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NCT ID: NCT02047097 Completed - Multiple Sclerosis Clinical Trials

Dimethyl Fumarate (DMF) Observational Study

ESTEEM
Start date: November 19, 2013
Phase:
Study type: Observational [Patient Registry]

The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl fumarate (DMF). Secondary objectives of this study in this population are as follows: To determine dimethyl fumarate (DMF) prescription and utilization patterns in routine clinical practice in patients with multiple sclerosis (MS); To assess the effectiveness of dimethyl fumarate (DMF) on multiple sclerosis (MS) disease activity and disability progression in routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score and multiple sclerosis (MS) relapse information; and To assess the effect of dimethyl fumarate (DMF) on health-related quality of life, healthcare resource consumption, and work productivity.

NCT ID: NCT02045979 Completed - Healthy Clinical Trials

Pharmacokinetics and Safety in Healthy Volunteers

Start date: January 31, 2014
Phase: Phase 1
Study type: Interventional

Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish pharmacokinetic similarity of BI 695501 to adalimumab.

NCT ID: NCT02045862 Completed - Overactive Bladder Clinical Trials

A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder

SYNERGY II
Start date: March 17, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.

NCT ID: NCT02042898 Completed - Clinical trials for Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Transfusion Requirements in Cardiac Surgery III

TRICS-III
Start date: January 20, 2014
Phase: N/A
Study type: Interventional

TRICS-III is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in high risk patients having cardiac surgery using a non-inferiority trial design.

NCT ID: NCT02036671 Completed - Clinical trials for Chronic Kidney Disease

Novel Endovascular Access Trial (NEAT)

NEAT
Start date: January 2014
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and efficacy of the FLEX System when used to create an arteriovenous fistula (AVF or AV fistula) percutaneously in patients with Chronic Kidney Disease (CKD) who require hemodialysis vascular access.

NCT ID: NCT02031783 Completed - Healthy Clinical Trials

Glucose:Fructose Versus Glucose Carbohydrate Ingestion and Endurance Performance

Start date: November 2013
Phase: N/A
Study type: Interventional

The primary objective is to show that multiple transportable carbohydrate ingestion is more effective in improving endurance performance compared to single transportable carbohydrate ingestion.

NCT ID: NCT02031302 Completed - Clinical trials for Aortic Valve Stenosis

RESPOND Post Market Study

RESPOND
Start date: May 27, 2014
Phase:
Study type: Observational

The purpose of the RESPOND post market study is to collect real world clinical and device performance outcomes data with the Lotus Valve System used in routine clinical practice to demonstrate that the commercially available Lotus Valve System is a safe and effective treatment for patients with severe calcific aortic stenosis.

NCT ID: NCT02026349 Completed - Influenza Clinical Trials

Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults - T705US316

Start date: January 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms.

NCT ID: NCT02024789 Completed - Down Syndrome Clinical Trials

A Study of RG1662 in Adults and Adolescents With Down Syndrome (CLEMATIS)

Start date: May 5, 2014
Phase: Phase 2
Study type: Interventional

This multi-center, randomized, double-blind, 3-arm, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RG1662 in adults and adolescents with Down syndrome. Subjects will be randomized to receive RG1662 either at low or high dose or placebo orally twice daily for 26 weeks.

NCT ID: NCT02023879 Completed - Clinical trials for Hypercholesterolemia

Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)

Start date: December 16, 2013
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin lipid modifying background therapy or as monotherapy in comparison with placebo in participants with primary hypercholesterolemia not treated with a statin. Secondary Objective: - To evaluate the effects on other lipid parameters of Alirocumab 150 mg Q4W versus placebo. - To evaluate the safety and tolerability of Alirocumab 150 mg Q4W. Alirocumab 75 mg Q2W was added as a calibrator arm.