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NCT ID: NCT03627091 Terminated - Crohn's Disease Clinical Trials

Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)

CARMEN CD 307
Start date: February 6, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).

NCT ID: NCT03600961 Terminated - Clinical trials for Ischemic Heart Disease

BIOFLOW-SV Portugal Registry

BIOFLOW-SV
Start date: July 5, 2018
Phase:
Study type: Observational

Assessment of the clinical safety and performance of the Orsiro drug-eluting stent in a real world setting in patients with small vessels with reference vessel diameter ≤2.75 mm

NCT ID: NCT03600805 Terminated - Clinical trials for Giant Cell Arteritis

Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

Start date: November 20, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of sarilumab in participants with giant cell arteritis (GCA) as assessed by the proportion of participants with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course. Secondary Objective: - To demonstrate the efficacy of sarilumab in participants with GCA compared to placebo, in combination with CS taper with regards to: - Clinical responses (such as responses based on disease remission rates, time to first disease flare) over time. - Cumulative CS (including prednisone) exposure. - To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with GCA. - To measure sarilumab serum concentrations in participants with GCA. - To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).

NCT ID: NCT03599622 Terminated - Crohn's Disease Clinical Trials

An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease

Start date: July 16, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and effectiveness of BMS-986165 compared to placebo in participants with moderately to severely active Crohn's Disease.

NCT ID: NCT03577899 Terminated - Clinical trials for Neovascular Age-related Macular Degeneration

Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-1)

Start date: September 25, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this clinical study is to evaluate the efficacy and safety of two different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelial growth factor (VEGF) antagonist active control, aflibercept intravitreal injection (2.0 mg/eye, Eylea®), in subjects with neovascular AMD.

NCT ID: NCT03566823 Terminated - Crohn's Disease Clinical Trials

Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)

CARMEN CD 306
Start date: July 17, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.

NCT ID: NCT03523728 Terminated - Clinical trials for Polycystic Kidney, Autosomal Dominant

A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD Patients

STAGED-PKD
Start date: October 4, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Primary Objective: To determine the effect of venglustat on the rate of total kidney volume (TKV) growth (Stage 1) and estimated glomerular filtration rate (eGFR) decline in participants at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) (Stage 2). Secondary Objectives: - To determine the effect of venglustat on the rate of renal function decline (Stage 1) and on the rate of TKV growth (Stage 2). - To evaluate the pharmacokinetics (PK) of venglustat in ADPKD participants (Stages 1 and 2). - To determine the effect of venglustat on pain and fatigue, based on participant reported diary (Stages 1 and 2). - Safety/tolerability objectives: - To characterize the safety profile of venglustat (Stages 1 and 2). - To evaluate the effect of venglustat on mood using Beck Depression Inventory II (BDI-II) (Stages 1 and 2). - To evaluate the effect of venglustat on the lens by ophthalmological examination (Stages 1 and 2).

NCT ID: NCT03521934 Terminated - Heart Failure Clinical Trials

Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

Start date: June 15, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable participants after admission for worsening heart failure (WHF) Secondary Objectives: To compare the effects of sotagliflozin to placebo on: - The total occurrences of HHF and urgent visit for HF - The occurrence of CV death - The occurrence of all-cause mortality - The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke - Change in Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score - Change in estimated glomerular filtration rate (eGFR)

NCT ID: NCT03517722 Terminated - Clinical trials for Lupus Erythematosus, Systemic

A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

Start date: April 16, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.

NCT ID: NCT03460704 Terminated - Clinical trials for Non Cystic Fibrosis Bronchiectasis

Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium.

PROMIS-II
Start date: January 29, 2018
Phase: Phase 3
Study type: Interventional

The primary objective of the trial was to investigate the effect of the use of inhaled colistimethate sodium (CMS), administered twice a day (b.i.d.) via a specific nebulizer for 12 months, compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFB) chronically infected with P. aeruginosa on the annualised frequency of pulmonary exacerbations.