Clinical trials: Therapy Strategies
Atherosclerotic Cardiovascular Disease
A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)
The purpose of this study was to assess the effectiveness of an "inclisiran first" implementation strategy (addition of inclisiran to maximally tolerated statin therapy immediately upon failure to achieve acceptable LDL-C with…
- Trial name
- V-INITIATE (NCT04929249)
- Testing
- Inclisiran
- Where
- 43 sites in United States
- Volunteers
- 450 people
- Sponsor
- Novartis Pharmaceuticals
Major Depressive Disorder (MDD)
A Duloxetine Dosing Strategy Study in Korean Patients With Major Depressive Disorder
The purpose of this study is to assess nausea severity in response to four different drug dosing strategies of Duloxetine (30 mg with food, 60 mg with food, 30 mg without food, and 60 mg without food) in Korean patients with…
- Trial name
- NCT00960986
- Testing
- Duloxetine hydrochloride
- Where
- 7 sites in South Korea
- Volunteers
- 249 people
- Sponsor
- Eli Lilly and Company
GERD
Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients
To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.
- Trial name
- MAESTRO (NCT00444275)
- Testing
- esomeprazole (Nexium®), Xolaam®
- Where
- France
- Volunteers
- 3,029 people
- Sponsor
- AstraZeneca
Coronary Stenosis
POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI)
The primary objective of this study is to study the safety and efficacy of the BiOSS LIM C with respect to Patient oriented Composite Endpoint (PoCE) at 12 months in a "real world" left-main bifurcation population and as compared…
- Trial name
- POLBOS-LM (NCT03508219)
- Testing
- BiOSS LIM C
- Where
- 15 sites in France, Italy and 1 more
- Volunteers
- 130 people
- Sponsor
- ECRI bv
Hypertension
Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension
This study will compare the safety and efficacy of initial combination treatment with aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine in patients with hypertension.
- Trial name
- ACCELERATE (NCT00797862)
- Testing
- Amlodipine, hydrochlorothiazide, Aliskiren
- Where
- 10 sites in Canada, Costa Rica and 8 more
- Volunteers
- 1,254 people
- Sponsor
- Novartis
HIV Infections
A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries
The overall objective of the CAB LA + RPV LA clinical development program is to develop a highly effective, well-tolerated, two-drug, LA injectable regimen which has the potential to offer improved treatment convenience…
- Trial name
- NCT04399551
- Testing
- CAB OLI, CAB LA, RPV OLI
- Where
- 18 sites in Belgium, France and 3 more
- Volunteers
- 437 people
- Sponsor
- ViiV Healthcare
Rheumatoid Arthritis
A Study of Tocilizumab and Methotrexate in Combination or as Monotherapy in Treatment-Naïve Patients With Early Rheumatoid Arthritis
This randomized, double-blind, placebo-controlled study will compare the efficacy with regard to sustained remission and safety of tocilizumab and methotrexate, in combination or as monotherapy, in treatment-naïve patients with…
- Trial name
- NCT01034137
- Testing
- methotrexate, tocilizumab [RoActemra/Actemra]
- Where
- 21 sites in Netherlands
- Volunteers
- 317 people
- Sponsor
- Hoffmann-La Roche
Major Depressive Disorder
Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder
This study investigates two different approaches to the change in antidepressant treatment when an initial treatment is not effective: early intervention or delayed intervention. Two hypothesis will be tested: 1.
- Trial name
- NCT00810069
- Testing
- Duloxetine Hydrochloride, Escitalopram
- Where
- 60 sites in Denmark, France and 9 more
- Volunteers
- 840 people
- Sponsor
- Eli Lilly and Company
Ulcerative Colitis
Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC)
To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX mesalamine once daily.
- Trial name
- NCT00446849
- Testing
- MMX Mesalamine
- Where
- 62 sites in United States
- Volunteers
- 290 people
- Sponsor
- Shire
HIV Infections
A Study to Evaluate the Safety and Efficacy of Adding Enfuvirtide to Oral Highly Active Antiretroviral Therapy (HAART) in Human Immunodeficiency Virus (HIV) Patients With Prior Treatment Experience
To assess the efficacy of enfuvirtide (Fuzeon) added to HAART compared to treatment with HAART alone in achieving and maintaining viral load suppression.
- Trial name
- INTENSE (NCT00487188)
- Testing
- Enfuvirtide, Highly active antiretroviral treatment (HAART)
- Where
- 39 sites in United States, Canada and 8 more
- Volunteers
- 47 people
- Sponsor
- Hoffmann-La Roche
HIV Infections
Study to Identify and Determine Best Implementation Practices for Injectable Cabotegravir+Rilpivirine in the United States (US)
Chronic human immunodeficiency virus (HIV) infection in adults continues to be characterized by increased development of resistant virus, increased transmission of resistant virus and issues associated with the long-term toxicity…
- Trial name
- NCT04001803
- Testing
- CAB LA+RPV LA
- Where
- 9 sites in United States
- Volunteers
- 115 people
- Sponsor
- ViiV Healthcare
Atrial Fibrillation, Percutaneous Coronary Intervention
Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)
The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate…
- Trial name
- NCT02164864
- Testing
- Dabigatran Etexilate 110mg, Warfarin 3mg, Aspirin
- Where
- 421 sites in United States, Argentina and 39 more
- Volunteers
- 2,725 people
- Sponsor
- Boehringer Ingelheim
Diabetes, Diabetes Mellitus, Type 2
Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin
This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with…
- Trial name
- BEGIN™ (NCT01388361)
- Testing
- insulin degludec, insulin aspart, liraglutide
- Where
- 124 sites in United States, Austria and 10 more
- Volunteers
- 413 people
- Sponsor
- Novo Nordisk A/S
Psoriasis
A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis
The purpose of this study is to demonstrate that Super-Responders (SRe; defined as psoriasis participants who receive on-label guselkumab treatment until week 20 and respond with a Psoriasis Area and Severity Index score (PASI) =…
- Trial name
- GUIDE (NCT03818035)
- Testing
- Guselkumab
- Where
- 90 sites in France, Germany
- Volunteers
- 880 people
- Sponsor
- Janssen-Cilag International NV
Myocardial Infarction
STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction
This study aims at evaluating, in a proof of concept approach, the outcome of patients presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in either a pre-hospital setting or community…
- Trial name
- NCT00623623
- Testing
- primary PCI, enoxaparin, catheterisation
- Where
- 201 sites in Austria, Belgium and 14 more
- Volunteers
- 1,899 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation, Percutaneous Coronary Intervention
A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention
The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various combinations of dual antiplatelet therapy (DAPT)…
- Trial name
- PIONEER AF-PCI (NCT01830543)
- Testing
- rivaroxaban 2.5 mg, rivaroxaban 15 mg, rivaroxaban 10 mg
- Where
- 348 sites in United States, Argentina and 23 more
- Volunteers
- 2,124 people
- Sponsor
- Janssen Scientific Affairs, LLC
Atrial Fibrillation
A Prospective, Open Label Study Evaluating Two Management Strategies on Gastrointestinal Symptoms in Patients Newly on Treatment With Pradaxa for the Prevention of Stroke and Systemic Embolism With Non-valvular Atrial Fibrillation
This is a prospective and open label study that aims to enroll approximately 1200 patients with non-valvular atrial fibrillation (NVAF) not previously treated with Pradaxa® and free of gastrointestinal symptoms (GIS) for at least…
- Trial name
- NCT01493557
- Testing
- pantoprazole, Pradaxa (dabigatran etexilate), Pradaxa, within 30 minutes after a meal
- Where
- 103 sites in United States, Canada
- Volunteers
- 1,067 people
- Sponsor
- Boehringer Ingelheim
Diabetes Mellitus, Type 2
Insulin Glulisine in Type 2 Diabetic Patients
To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled…
- Trial name
- Basal Plus (NCT00360698)
- Testing
- Insulin Glargine, Glimepiride, Insulin Glulisine
- Where
- 3 sites in United States, Russia and 1 more
- Volunteers
- 106 people
- Sponsor
- Sanofi
Arthritis, Rheumatoid
IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis
Regarding Tofacitinib, newly introduced on the market, few data on drug retention and no data on the factors predictive of Tofacitinib drug survival in patients with RA are available.
- Trial name
- NCT03981900
- Testing
- Tofacitinib
- Where
- 66 sites in France
- Volunteers
- 314 people
- Sponsor
- Pfizer
Rheumatoid Arthritis
A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment
This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis.
- Trial name
- NCT00810199
- Testing
- tocilizumab [RoActemra/Actemra], methotrexate
- Where
- 137 sites in United States, Brazil and 18 more
- Volunteers
- 556 people
- Sponsor
- Hoffmann-La Roche