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NCT ID: NCT02675816 Terminated - Clinical trials for Obstructive Sleep Apnea

Inspire® Upper Airway Stimulation System

RCT
Start date: August 2015
Phase: Phase 4
Study type: Interventional

The purpose of this post-market study is to assess safety and effectiveness of Inspire Upper Airway System (UAS) in a commercial setting. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe obstructive sleep apnea (OSA) using a randomized controlled trial design.

NCT ID: NCT02673697 Terminated - Aortic Stenosis Clinical Trials

Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement

PERSIST-AVR
Start date: March 22, 2016
Phase: N/A
Study type: Interventional

Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively. The trial will enroll up to 1234 subjects, but accrual may stop earlier at approximately 900 or 1050 subjects These subjects will be enrolled at approximately 60 worldwide investigational sites where the device is commercially available The primary objective of this trial is to test the safety and efficacy of Perceval versus standard sutured stented bioprosthetic aortic valves among the intended trial population.

NCT ID: NCT02670330 Terminated - Clinical trials for Epidermolysis Bullosa

Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa

Start date: June 9, 2015
Phase: Phase 3
Study type: Interventional

The study aimed to assess the long-term safety of topical use of Zorblisa (SD-101-6.0) in participants with Epidermolysis Bullosa (EB).

NCT ID: NCT02670083 Terminated - Alzheimer's Disease Clinical Trials

A Study Evaluating the Efficacy and Safety of Crenezumab Versus Placebo in Participants With Prodromal to Mild Alzheimer's Disease (AD).

CREAD
Start date: March 22, 2016
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose. Participants will then have the option to enter the Open Label Extension (OLE) study if eligible. Participants who do not enter the OLE study will have additional follow-up visits at 16 and 52 weeks after the last dose, primarily for safety and also for limited efficacy assessments.

NCT ID: NCT02665689 Terminated - Clinical trials for Macular Edema, Cystoid

Influence of Diabetes Control on Treatment of Diabetic Macular Edema With Ranibizumab

DORO
Start date: January 18, 2016
Phase: Phase 4
Study type: Interventional

The aim of the prospective randomized study is to investigate whether a intensified diabetic control program leads to better final visual acuity and less frequent diabetic ocular complications in patients with diabetic retinopathy when compared with a normal diabetic treatment.

NCT ID: NCT02665364 Terminated - Clinical trials for Systemic Lupus Erythematosus

Phase IIb Study of IFN-K in Systemic Lupus Erythematosus

Start date: September 23, 2015
Phase: Phase 2
Study type: Interventional

The safety and immunogenicity of the IFNα-Kinoid (IFN-K) have been evaluated in a phase I clinical study conducted in subjects with Systemic Lupus Erythematosus (SLE). Preliminary results showed acceptable safety profile and patients developped antibodies response. The principal aim of the present study is to confirm the neutralization of the interferon gene signature and the clinical efficacy of IFN-K in subjects with SLE. In addition, the immune responses and the safety elicited by IFN-K will also be evaluated.

NCT ID: NCT02663908 Terminated - Prostate Cancer Clinical Trials

A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease

PRONOUNCE
Start date: April 19, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in subjects with prostate cancer and cardiovascular disease.

NCT ID: NCT02660359 Terminated - Clinical trials for Urinary Incontinence

Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2

CONTENT2
Start date: July 8, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® doses (600 units [U] and 800 U), compared to placebo in reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS).

NCT ID: NCT02657356 Terminated - Clinical trials for Connective Tissue Disease-Associated Pulmonary Arterial Hypertension

Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST

Start date: October 4, 2016
Phase: Phase 3
Study type: Interventional

This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with connective tissue disease-associated pulmonary arterial hypertension to determine the recommended dose range and evaluate the change from baseline in 6-minute walk distance (6MWD) following 24 weeks of study participation.

NCT ID: NCT02656329 Terminated - Heart Failure Clinical Trials

International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device

ADMIRE-ICD
Start date: December 30, 2015
Phase: Phase 3
Study type: Interventional

This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable cardioverter defibrillator (ICD) implantation, in New York Health Association (NYHA) class II and III heart failure participants with 25%<=left ventricular ejection fraction (LVEF)<=35%, and in particular, for identifying participants who are at low risk for sudden cardiac death and who would not benefit, or may suffer harm, from implantation of an ICD device.