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Center for Global Research Data

Assessing heterogeneity in relative treatment efficacy by age, sex and comorbidity.

Lead Investigator: David McAllister, University of Glasgow
Title of Proposal Research: Assessing heterogeneity in relative treatment efficacy by age, sex and comorbidity.
Vivli Data Request: 5483
Funding Source: This research is funded via Dr McAllister’s Wellcome Trust Fellowship Ref: 201492Z16Z
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Less than half of patients with a chronic condition have only a single disease. Most have multiple diseases – or multimorbidity. People with multimorbidity are less likely to receive recommended treatments; Partly because clinical practice guidelines, which make treatment recommendations, rarely provide specific treatment recommendations for people with multimorbidity.

This rarity reflects uncertainty as to whether standard treatment recommendations should apply to multimorbidity. Clinical trials usually resolve such uncertainties, but it is not feasible to conduct trials large enough to examine the most common patterns of multimorbidity, even for the most important treatments. Analysing data from large healthcare databases is a feasible alternative, but such analyses have in several cases led to inaccurate conclusions.

Therefore, individual clinicians have to estimate treatment effectiveness in people with multimorbidity unsupported by guidance or high quality evidence. There is therefore a need to develop novel methods, for determining treatment effectiveness in multimorbidity.
Evidence synthesis (ES), where modellers combine data from multiple sources, is a promising approach. Using ES, results from clinical trials may be combined with other data to estimate treatment effects for particular groups. However, ES has not yet been developed for the problem of multimorbidity and there are a number of additional challenges.

In a project funded by the Wellcome Trust we plan to develop and validate an approach to determine treatment effectiveness in people with multimorbidity. As part of that project we aim to determine whether and how, for different groups of related drug-classes, relative treatment effects differ according to the presence or absence of specific co-existing diseases.

We have identified 201 suitable trials. We will use these to ‘survey’ how treatment effects vary according to the presence of co-existing diseases for different types of drug and treatment outcome (eg blood pressure, mortality).

Rather than focusing on individual drugs we will summarise this variation for drug-classes and groupings of related drug classes. We will use statistical models similar to those outlined in the NICE Technical Support Documents for ES.

This work will improve the health of people with multimorbidity. If we find that there is very little variation, it will considerably simplify the challenge of determining treatment effectiveness in multimorbidity. If instead we discover substantial variation, this knowledge may be incorporated into ES, resulting in more robust valid estimates of treatment effectiveness.

Requested Studies:

A Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison of 12-week Treatment of Two Doses (5 Mcg and 10 Mcg) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) i
Data Contributor: Boehringer Ingelheim
Study ID: NCT00240435
Sponsor ID: 205.252

A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Comparison of One-Year Treatment of Two Doses (5mg and 10mg) of Tiotropium Inhalation Solution Delivered by the Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Data Contributor: Boehringer Ingelheim
Study ID: NCT00168844
Sponsor ID: 205.254

A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Comparison of One-Year Treatment of Two Doses (5mg and 10mg) of Tiotropium Inhalation Solution Delivered by the Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Data Contributor: Boehringer Ingelheim
Study ID: NCT00168831
Sponsor ID: 205.255

A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-week Maintenance Phase in Patients With Early Parkinsons Disease (PD).
Data Contributor: Boehringer Ingelheim
Study ID: NCT00479401
Sponsor ID: 248.524

A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Efficacy Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over a 12-week Treatment Phase in Early Parkinson’s Disease Patients (PramiBID)
Data Contributor: Boehringer Ingelheim
Study ID: NCT00402233
Sponsor ID: 248.622

A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With Pramipexole (Sifrol, Mirapexin) 0.125-0.75 mg/Day Per os to Investigate the Long-term Efficacy, Safety and Tolerability in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome for 26 Weeks Followed by a 26 Week Open-label Extension Treatment Period
Data Contributor: Boehringer Ingelheim
Study ID: NCT00472199
Sponsor ID: 248.629

A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD).
Data Contributor: Boehringer Ingelheim
Study ID: NCT00466167
Sponsor ID: 248.525

A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson’s Disease.
Data Contributor: Boehringer Ingelheim
Study ID: NCT00321854
Sponsor ID: 248.595

A Randomised, Double-blind, Double Dummy, Active Controlled, Parallel Group, Forced Titration Study to Compare the Fixed-dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 25mg (T80/HCTZ25) Versus Telmisartan 80mg (T80) Monotherapy as First Line Therapy in Patients With Grade 2 or Grade 3 Hypertension (Systolic Blood Pressure (SBP) >=160 mmHg and Diastolic Blood Pressure (DBP) >=100 mmHg)
Data Contributor: Boehringer Ingelheim
Study ID: NCT00926289
Sponsor ID: 502.550

A Randomized, Double-blind, Placebo-controlled Two-year Trial to Examine the Changes in Exercise Endurance and COPD Treated With Tiotropium Once Daily (EXACTT)
Data Contributor: Boehringer Ingelheim
Study ID: NCT00525512
Sponsor ID: 205.368

Effect of Inhalation of Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients (a Randomised, Double-blind, Double-dummy, Parallel Group, One-year Study).
Data Contributor: Boehringer Ingelheim
Study ID: NCT00563381
Sponsor ID: 205.389

A Prospective Randomised Open- Label Blinded-Endpoint (PROBE) Trial Comparing Telmisartan (MICARDIS®) (40-80-80mg QD) and Ramipril (2.5-5–10mg QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring. PRISMA = Prospective Randomised Investigation of the Safety and Efficacy of Micardis® vs Ramipril Using ABPM
Data Contributor: Boehringer Ingelheim
Study ID: NCT00274612
Sponsor ID: 502.391

A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Investigate the Efficacy of Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy VIVALDI-Study
Data Contributor: Boehringer Ingelheim
Study ID: NCT00153023
Sponsor ID: 502.396

A Prospective, Randomized, Double-Blind, Forced Titration Trial to Compare the Efficacy of MICARDIS® (Telmisartan 80 mg p.o. Once Daily) and Diovan® (Valsartan 160 mg p.o. Once Daily) Using Ambulatory Blood Pressure Monitoring (ABPM) in Patients With Mild to Moderate Hypertension After Missing One Dose
Data Contributor: Boehringer Ingelheim
Study ID: NCT00034840
Sponsor ID: 502.327

A Randomised, Double-blind, Placebo-controlled, Multicenter Trial to Investigate the Preventive Effect of BIBR277 (Telmisartan) in Diabetic Nephropathy on Transition From Incipient to Overt Nephropathy – Incipient to Overt : Angiotensin 2 Receptor Blocker, Telmisartan, Investigation on Type 2 Diabetic Nephropathy (INNOVATION Study –
Data Contributor: Boehringer Ingelheim
Study ID: NCT00153088
Sponsor ID: 502.413

A Prospective, Randomised, Open-Label, Blinded-Endpoint, Parallel Group, Multicentre, Forced-Titration, 14-Week Treatment Study Comparing MICARDIS® (Telmisartan 40-80-80 mg, QD) and ALTACE® (Ramipril 2.5-5-10 mg, QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring
Data Contributor: Boehringer Ingelheim
Study ID: NCT00274599
Sponsor ID: 502.392

A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare MICARDIS® (Telmisartan) 80 mg Versus COZAAR® (Losartan) 100 mg, in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy (AMADEO Study)
Data Contributor: Boehringer Ingelheim
Study ID: NCT00168857
Sponsor ID: 502.397

Spiriva Assessment of FEV1 – (SAFE-Portugal). The Effect of Inhaled Tiotropium Bromide (18 Mcg Once Daily) on the Change in FEV1 During Treatment in Patients With COPD. A Three-month Parallel Group, Double-blind, Randomised, Placebo-controlled Study.
Data Contributor: Boehringer Ingelheim
Study ID: NCT00239408
Sponsor ID: 205.282

Effects of Inhaled Tiotropium Bromide on Severity of Airflow Obstruction During Long-term Treatment in Patients With Moderately Severe Copd. Impact on Severity and Incidence of Exacerbations.
Data Contributor: Boehringer Ingelheim
Study ID: NCT00274014
Sponsor ID: 205.214

A Six-Week, Randomized, Double-Blind, Quadruple-Dummy Parallel Group Multiple Dose Study Comparing the Efficacy and Safety of Tiotropium Inhalation Capsules Plus Formoterol Inhalation Capsules to Salmeterol Inhalation Aerosol Plus Fluticasone Inhalation Aerosol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Data Contributor: Boehringer Ingelheim
Study ID: NCT00239421
Sponsor ID: 205.287

A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Proportion of Patients Experiencing an Exacerbation and Proportion of Patients Hospitalized for an Exacerbation Over 6 Months During Treatment With Tiotropium 18 Mcg Capsule Once Daily in Patients With COPD in a Veterans Affairs Setting
Data Contributor: Boehringer Ingelheim
Study ID: NCT00274547
Sponsor ID: 205.266

Effect of a 9-month Treatment of SPIRIVA® on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease. Validation of a New HRQoL Questionnaire Appropriate to Common Daily Practice. (TIPHON Study)
Data Contributor: Boehringer Ingelheim
Study ID: NCT00274053
Sponsor ID: 205.256

A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol in a 12 Week, Randomized, Double-Blind, Double-Dummy Parallel Group Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).
Data Contributor: Boehringer Ingelheim
Study ID: NCT00274560
Sponsor ID: 205.264

Spiriva® Assessment of FEV1 (SAFE). The Effect of Inhaled Tiotropium Bromide (18 Mcg Once Daily) on the Change in FEV1 During Long-term Treatment in Patients With COPD. A One-year Parallel Group, Double-blind, Randomised, Placebo-controlled Study
Data Contributor: Boehringer Ingelheim
Study ID: NCT00277264
Sponsor ID: 205.259

Acute and Long-term Effects of Once Daily Oral Inhalation of Tiotropium 18 Mcg Dry Powder Inhalation Capsules in a Placebo Controlled Parallel Group Design Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) of Different Severity
Data Contributor: Boehringer Ingelheim
Study ID: NCT00274573
Sponsor ID: 205.257

A Six Month, Randomized, Double-blind (Within Formulation), Multiple Dose Trial to Compare the Safety and Efficacy of 20 mcg and 40 mcg of Ipratropium Bromide, as Delivered by the RESPIMAT Device, to 18 mcg ATROVENT® Inhalation Aerosol (x 2 Puffs) and Respective Placebos in Adults, With Chronic Obstructive Pulmonary Disease
Data Contributor: Boehringer Ingelheim
Study ID: NCT02177344
Sponsor ID: 244.2484

A Randomised, Double- Blind, Placebo-controlled, 6 Week Parallel-group Trial on the Efficacy and Safety of the Angiotensin II Receptor Antagonist Micardis® (Telmisartan 20 mg, 40 mg or 80 mg, p.o. Once Daily) or Hydrochlorothiazide 12.5 mg p.o. Once Daily in the Management of Patients With Isolated Systolic Hypertension (ISH). (ARAMIS – Study = Angiotensin II Receptor Antagonist Micardis in Isolated Systolic Hypertension)
Data Contributor: Boehringer Ingelheim
Study ID: NCT02175355
Sponsor ID: 502.254

A PROBE (Prospective, Randomised, Open-Label, Blinded Endpoint) Trial to Investigate the Efficacy and Safety of Telmisartan 40-80mg Once Daily Compared With 10-20 mg Enalapril Once Daily Over a Period of 24 Weeks in Elderly Patients With Blood Hypertension
Data Contributor: Boehringer Ingelheim
Study ID: NCT02177461
Sponsor ID: 502.317

A Prospective Randomized Open-Label Blinded End Point (PROBE) Trial Comparing MICARDIS® (Telmisartan) (80 mg QD) and Valsartan (80 mg QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring.
Data Contributor: Boehringer Ingelheim
Study ID: NCT02177396
Sponsor ID: 502.256

A Phase IIIb-IV, Randomised, Open Label Trial on Efficacy and Safety of 2 Parallel Groups: Full Dose Tenecteplase Combined With Unfractionated Heparin or Enoxaparin in Acute Myocardial Infarction in the Prehospital Setting (ASSENT 3 Plus) ASSENT 3 Plus Was a Satellite Study to ASSENT 3 (Main Study) ASSENT (ASsessment of the Safety and Efficacy of New Thrombolytic Regimens)
Data Contributor: Boehringer Ingelheim
Study ID: NCT02181998
Sponsor ID: 1123.11

A Multiple Dose Comparison of Tiotropium Inhalation Capsules, Salmeterol Inhalation Aerosol and Placebo in a Six-Month, Double-Blind, Double-Dummy, Safety and Efficacy Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Data Contributor: Boehringer Ingelheim
Study ID: NCT02172287
Sponsor ID: 205.130

A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (30 mg QD and 60 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Nonerosive Gastroesophageal Reflux Disease (GERD)
Data Contributor: Takeda
Study ID: NCT00321984
Sponsor ID: T-GD05-137

A Phase 3 Multicenter, Randomized, Double-Blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy of TAK-390MR (30 mg QD) Compared to Placebo on Relief of Nocturnal Heartburn in Subjects With Symptomatic Gastroesophageal Reflux Disease (GERD)
Data Contributor: Takeda
Study ID: NCT00627016
Sponsor ID: T-GD07-170

A Phase 3, Open-Label Study to Assess the Long-Term Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD)
Data Contributor: Takeda
Study ID: NCT00255190
Sponsor ID: T-GI04-088

A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60 mg Once- Daily [QD] and 90 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis
Data Contributor: Takeda
Study ID: NCT00251693
Sponsor ID: T-EE04-084

A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60 mg Once-daily [QD] and 90 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis
Data Contributor: Takeda
Study ID: NCT00251719
Sponsor ID: T-EE04-085

A Phase 3 Study to Evaluate the Safety and Efficacy of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis
Data Contributor: Takeda
Study ID: NCT00255164
Sponsor ID: T-EE04-086

A Phase 3 Study to Evaluate the Safety and Efficacy of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis
Data Contributor: Takeda
Study ID: NCT00255151
Sponsor ID: T-EE04-087

A Phase 3 Study to Evaluate the Safety and Efficacy of TAK-390MR (30 mg QD and 60 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis.
Data Contributor: Takeda
Study ID: NCT00321737
Sponsor ID: T-EE05-135

A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (60 mg Once-Daily (QD) and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)
Data Contributor: Takeda
Study ID: NCT00251745
Sponsor ID: T-GD04-082

A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)
Data Contributor: Takeda
Study ID: NCT00251758
Sponsor ID: T-GD04-083

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis
Data Contributor: Takeda
Study ID: NCT00783718
Sponsor ID: C13006

Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
Data Contributor: UCB
Study ID: NCT01087762
Sponsor ID: AS001

Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Adult-Onset Active and Progressive Psoriatic Arthritis (PsA)
Data Contributor: UCB
Study ID: NCT01087788
Sponsor ID: PsA001

Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 48 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL (5 mcg [2 Actuations of 2.5 mcg] and 10 mcg [2 Actuations of 5 mcg]) Delivered by the Respimat® Inhaler, in Patients With Chronic Obstructive Pulmonary Disease (COPD
Data Contributor: Boehringer Ingelheim
Study ID: NCT00782509
Sponsor ID: 1222.12

Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 48 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL (5 mcg [2 Actuations of 2.5 mcg] and 10 mcg [2 Actuations of 5 mcg]) Delivered by the Respimat® Inhaler, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Data Contributor: Boehringer Ingelheim
Study ID: NCT00782210
Sponsor ID: 1222.11

A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 48 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL (5 µg [2 Actuations of 2.5 ug] and 10 ug [2 Actuations of 5 ug]) Delivered by the Respimat® Inhaler, and 48 Weeks of Twice Daily Foradil® (12 µg) Delivered by the Aerolizer® Inhaler, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Data Contributor: Boehringer Ingelheim
Study ID: NCT00793624
Sponsor ID: 1222.13

A Prospective, Randomized, Double-Blind, Double-Dummy, Titration-to-Response Trial Comparing MICARDIS® (Telmisartan) (40 & 80 mg QD) and COZAAR® (Losartan) (50 & 100 mg QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring
Data Contributor: Boehringer Ingelheim
Study ID: NCT02200640
Sponsor ID: 502.343

A Prospective, Randomised, Double-Blind, Double-Dummy, Titration-to-Response Trial Comparing MICARDIS® (Telmisartan) (40 or 80 mg p.o. Once Daily) and COZAAR® / LORZAAR® (Losartan) (50 or 100 mg p.o. Once Daily) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (TOPAS STUDY = Telmisartan and LOsartan ComParative ABPM Study)
Data Contributor: Boehringer Ingelheim
Study ID: NCT02200653
Sponsor ID: 502.344

A Randomised, Double-blind, Parallel Group, 12 Week Study, Comparing the Effect of Once Daily Tiotropium Lactose Capsule With Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD), naïve to Anticholinergic Agents in Addition to Receiving Their Usual COPD Care
Data Contributor: Boehringer Ingelheim
Study ID: NCT00274079
Sponsor ID: 205.276

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg and 25 mg Administered Once Daily) as Add on to Pre-existing Antidiabetic Therapy Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycaemic Control
Data Contributor: Boehringer Ingelheim
Study ID: NCT01164501
Sponsor ID: 1245.36

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 12 Weeks in Hypertensive Patients With Type 2 Diabetes Mellitus
Data Contributor: Boehringer Ingelheim
Study ID: NCT01370005
Sponsor ID: 1245.48

A Multi-Center, Randomized, Parallel-Group, Open-Label Study to Compare Prescription Non-Steroidal Anti-Inflammatory Drug (NSAID) Changes, Health Care Utilization, Efficacy and Safety of Meloxicam 7.5 mg Versus Usual Care Administration of Prescription NSAIDs in a Managed Healthcare Setting in Patients With Osteoarthritis of the Hip, Knee, Hand or Spine
Data Contributor: Boehringer Ingelheim
Study ID: NCT02183064
Sponsor ID: 107.210

A Double-blind, Double-dummy, Randomised, Parallel-group Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release Versus Pramipexole Immediate Release Administered Orally for 18 Weeks in Chinese Parkinson’s Disease (PD) Patients Who Can be Concomitantly Treated With Levodopa
Data Contributor: Boehringer Ingelheim
Study ID: NCT01191944
Sponsor ID: 248.671

A Prospective, Randomised, Double-blind, Double-dummy Trial to Compare the Efficacy of Micardis® (Telmisartan) (80 mg p.o. Once Daily) and Valsartan (160 mg p.o. Once Daily) in Patients With Mild-to-moderate Hypertension After Missing One Dose Using Ambulatory Blood Pressure Monitoring
Data Contributor: Boehringer Ingelheim
Study ID: NCT02242318
Sponsor ID: 502.376

A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler (TIOSPIR)
Data Contributor: Boehringer Ingelheim
Study ID: NCT01126437
Sponsor ID: 205.452

A Randomised, Double Blind, Parallel Group Study to Assess the Efficacy and Safety of 12 Weeks of Once Daily, Orally Inhaled, Co-administration of Olodaterol 5µg (Delivered by the Respimat® Inhaler) and Tiotropium 18µg (Delivered by the HandiHaler®) Compared to Once Daily, Orally Inhaled, Co-administration of Placebo (Delivered by the Respimat® Inhaler) and Tiotropium 18µg (Delivered by the HandiHaler®) in Patients With Chronic Obstructive Pulmonary Disease (COPD)[ANHELTO TM 1]
Data Contributor: Boehringer Ingelheim
Study ID: NCT01694771
Sponsor ID: 1222.51

A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Data Contributor: Boehringer Ingelheim
Study ID: NCT01335464
Sponsor ID: 1199.32

A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Data Contributor: Boehringer Ingelheim
Study ID: NCT01335477
Sponsor ID: 1199.34

A Phase 3, Randomized, Multicenter, Allopurinol and Placebo-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout.
Data Contributor: Takeda
Study ID: NCT00174915
Sponsor ID: C02-009

A Phase 3, Randomized, Multicenter Study Comparing the Safety and Efficacy of Oral Febuxostat Versus Allopurinol in Subjects With Gout
Data Contributor: Takeda
Study ID: NCT00102440
Sponsor ID: C02-010

A Phase 3, Open-Label, Randomized, Allopurinol-Controlled Study to Assess the Long-Term Safety of Oral Febuxostat in Subjects With Gout
Study ID: NCT00175019
Sponsor ID: C02-021
Data Contributor: Takeda

A Phase 3, Randomized, Multicenter, Double-Blind, Allopurinol-Controlled Study Assessing the Efficacy and Safety of Oral Febuxostat in Subjects With Gout.
Data Contributor: Takeda
Study ID: NCT00430248
Sponsor ID: F-GT06-153

A 12-week Randomised, Double Blind, Placebo Controlled, Parallel Group Trial Evaluating the Efficacy and Safety of Inhaled Tiotropium 18μg q.d. in Patients With COPD and a Concomitant Diagnosis of Asthma
Data Contributor: Boehringer Ingelheim
Study ID: NCT00152984
Sponsor ID: 205.301

A PROBE (Prospective, Randomised, Open-label, Blinded Endpoint) Trial to Investigate the Efficacy and Safety of Telmisartan 40-80 mg Once Daily Compared With Losartan 50-100 mg Once Daily Over a Period of 12 Weeks, and of Telmisartan 80 mg + HCTZ 12.5 mg Once Daily Compared With Losartan 100 mg Once Daily + HCTZ 12.5 mg Once Daily Over a Period of Further 12 Weeks in Mild to Moderate Hypertensive Patients (Grade 1 and Grade 2 WHO-ISH Guidelines 1999)
Data Contributor: Boehringer Ingelheim
Study ID: NCT02172586
Sponsor ID: 502.316

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (5 mcg/Day) Over 48 Weeks as add-on Controller Therapy on Top of Usual Care in Patients With Severe Persistent Asthma
Data Contributor: Boehringer Ingelheim
Study ID: NCT00776984
Sponsor ID: 205.417

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (5 mcg/Day) Over 48 Weeks as add-on Controller Therapy on Top of Usual Care in Patients With Severe Persistent Asthma
Data Contributor: Boehringer Ingelheim
Study ID: NCT00772538
Sponsor ID: 205.416

Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab’ Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn’s Disease.
Data Contributor: UCB
Study ID: NCT00552058
Sponsor ID: C87085

A Multi-center, Double-blind, Parallel-group, Placebo Controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures.
Data Contributor: UCB
Study ID: NCT00490035
Sponsor ID: N01252

An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures
Data Contributor: UCB
Study ID: NCT00464269
Sponsor ID: N01253

A Randomised, Double-blind, Active-controlled Study to Evaluate the Impact of Stepwise Withdrawal of Inhaled Corticosteroid Treatment in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) on Optimized Bronchodilator Therapy
Data Contributor: Boehringer Ingelheim
Study ID: NCT00975195
Sponsor ID: 352.2046

A 24-week Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Oral Administration of Empagliflozin + Metformin Compared With the Individual Components of Empagliflozin or Metformin in Drug Naive Patients With Type 2 Diabetes Mellitus
Data Contributor: Boehringer Ingelheim
Study ID: NCT01719003
Sponsor ID: 1276.1

A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination With Metformin in Subjects With Type 2 Diabetes
Data Contributor: Takeda
Study ID: NCT00856284
Sponsor ID: SYR-322_305

A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Glimepiride
Data Contributor: Lilly
Study ID: NCT01075282
Sponsor ID: 11374

A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients With Moderate-to-Severe Plaque Psoriasis
Data Contributor: Lilly
Study ID: NCT01474512
Sponsor ID: 12972

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis
Data Contributor: Lilly
Study ID: NCT01597245
Sponsor ID: 12973

A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate to Severe Plaque Psoriasis With a Long-Term Extension Period
Data Contributor: Lilly
Study ID: NCT01646177
Sponsor ID: 13685

PHIRST-1: Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment in Patients With Pulmonary Arterial Hypertension
Data Contributor: Lilly
Study ID: NCT00125918
Sponsor ID: 10303

A Phase 3, Randomized, Double Blind, Placebo and Tamsulosin Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil Once a Day Dosing for 12 Weeks in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Data Contributor: Lilly
Study ID: NCT00861757
Sponsor ID: 10487

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, 5-Group, Multinational Study to Evaluate the Efficacy, Dose Response, and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Data Contributor: Lilly
Study ID: NCT00384930
Sponsor ID: 9797

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multinational Study to Evaluate the Efficacy and Safety of Daily Tadalafil for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Data Contributor: Lilly
Study ID: NCT00827242
Sponsor ID: 10893

A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil 2.5 and 5 mg Once Daily Dosing for 12 Weeks for the Treatment of Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia in Men With Both Erectile Dysfunction and Benign Prostatic Hyperplasia
Data Contributor: Lilly
Study ID: NCT00855582
Sponsor ID: 11667

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Efficacy of Daily Tadalafil for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia on Concomitant Alpha1-Adrenergic Blocker Therapy
Data Contributor: Lilly
Study ID: NCT00848081
Sponsor ID: 11668

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Data Contributor: Lilly
Study ID: NCT00970632
Sponsor ID: 12932

A Randomized, Parallel-Arm, Double-Blinded Study Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Patients With Type 2 Diabetes Mellitus on Sulfonylurea Therapy (AWARD-8: Assessment of Weekly AdministRation of LY2189265 in Diabetes – 8)
Data Contributor: Lilly
Study ID: NCT01769378
Sponsor ID: 13193

A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-Weekly Dulaglutide With Once-Daily Liraglutide in Patients With Type 2 Diabetes (AWARD-6: Assessment of Weekly AdministRation of LY2189265 in Diabetes-6)
Data Contributor: Lilly
Study ID: NCT01624259
Sponsor ID: 11377

The Impact of LY2189265 Versus Insulin Glargine in Combination With Insulin Lispro for the Treatment to Target of Type 2 Diabetes Mellitus (AWARD-4: Assessment of Weekly AdministRation of LY2189265 in Diabetes – 4)
Data Contributor: Lilly
Study ID: NCT01191268
Sponsor ID: 11376

The Impact of LY2189265 Versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus (AWARD-3: Assessment of Weekly AdministRation of LY2189265 in Diabetes-3)
Data Contributor: Lilly
Study ID: NCT01126580
Sponsor ID: 11375

A Randomized, Placebo-Controlled Comparison of the Effects of Two Doses of LY2189265 or Exenatide on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Pioglitazone (AWARD-1: Assessment of Weekly Administration of LY2189265 in Diabetes-1)
Data Contributor: Lilly
Study ID: NCT01064687
Sponsor ID: 11373

A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin
Data Contributor: Lilly
Study ID: NCT00734474
Sponsor ID: 11422

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome
Data Contributor: Takeda
Study ID: NCT00968708
Sponsor ID: SYR-322_402

Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis
Data Contributor: Lilly
Study ID: NCT00051558
Sponsor ID: 6484

Effects of LY333334 in the Treatment of Postmenopausal Women With Osteoporosis
Data Contributor: Lilly
Study ID: NCT00670501

Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis
Data Contributor: Lilly
Study ID: NCT00670319
Sponsor ID: 1363

A Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Valsartan in Subjects With Essential Hypertension
Data Contributor: Takeda
Study ID: NCT00591578
Sponsor ID: TAK-491_301

A Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Ramipril in Subjects With Essential Hypertension
Data Contributor: Takeda
Study ID: NCT00760214
Sponsor ID: 01-06-TL-491-020

A Double-Blind, Randomized, Placebo-Controlled, 5-Arm Titration Study to Evaluate the Efficacy and Safety of TAK-491 When Compared With Valsartan and Olmesartan in Subjects With Essential Hypertension
Data Contributor: Takeda
Study ID: NCT00696436
Sponsor ID: 01-06-TL-491-019

An 8-Month Phase 3, Open-Label Study With a Blinded Reversal Phase to Evaluate the Safety and Tolerability of TAK-491 in Subjects With Essential Hypertension
Data Contributor: Takeda
Study ID: NCT00696384
Sponsor ID: 01-06-TL-491-016

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 in Black Subjects With Essential Hypertension
Data Contributor: Takeda
Study ID: NCT00591253
Sponsor ID: 01-06-TL-491-011

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 When Co-administered With Amlodipine 5 mg in Subjects With Essential Hypertension
Data Contributor: Takeda
Study ID: NCT00591266
Sponsor ID: 01-05-TL-491-010

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 When Co-administered With Chlorthalidone in Subjects With Essential Hypertension
Data Contributor: Takeda
Study ID: NCT00591773
Sponsor ID: 01-05-TL-491-009

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 in Subjects With Essential Hypertension
Data Contributor: Takeda
Study ID: NCT00696241
Sponsor ID: 01-05-TL-491-008

A Ph II/III Seamless, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Reduction in Signs and Symptoms and Inhibition of Structural Damage During Treatment With Tocilizumab Versus Placebo in Patients With Ankylosing Spondylitis Who Have Failed Non-steroidal Anti-inflammatory Drugs and Are naïve to TNF Antagonist Therapy NSAIDs
Data Contributor: Roche
Study ID: NCT01209702
Sponsor ID: NA22823

A Randomized, Double-blind Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis
Data Contributor: Roche
Study ID: NCT00106535
Sponsor ID: WA17823

A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis
Data Contributor: Roche
Study ID: NCT01119859
Sponsor ID: WA19924

A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab (TCZ), as a Monotherapy and in Combination With Methotrexate (MTX), Versus Methotrexate in Patients With Early, Moderate to Severe Rheumatoid Arthritis
Data Contributor: Roche
Study ID: NCT01007435
Sponsor ID: WA19926

A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis
Data Contributor: Roche
Study ID: NCT01232569
Sponsor ID: NA25220

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)
Data Contributor: Roche
Study ID: NCT01287117
Sponsor ID: Q4881g

A Phase III, Multicenter, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria Who Remain Symptomatic Despite Antihistamine Treatment (H1)
Data Contributor: Roche
Study ID: NCT01292473
Sponsor ID: Q4882g

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
Data Contributor: Roche
Study ID: NCT01264939
Sponsor ID: Q4883g

Update: This data request was withdrawn on 28-Apr-2022 by the researcher.