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NCT ID: NCT02679404 Terminated - Aortic Stenosis Clinical Trials

Sorin Universal REgistry on Aortic Valve Replacement

SURE-AVR
Start date: May 2015
Phase:
Study type: Observational

Multi-center, International, Prospective, Non comparative, Non randomized, Open label. 5,000 patients to be enrolled approximately worldwide. The objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance with the Instructions for Use (IFU). This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry in accordance with the local applicable regulations.

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: NCT02641392 Terminated - Crohn's Disease Clinical Trials

A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

Start date: July 25, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study. The GED-0301-CD-003 trial was not initiated; see detailed description.

NCT ID: NCT02628028 Terminated - Clinical trials for Rheumatoid Arthritis

A Study of LY3337641 in Rheumatoid Arthritis

RAjuvenate
Start date: August 22, 2016
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the safety and effectiveness of LY3337641 in adults with rheumatoid arthritis (RA).

NCT ID: NCT02618577 Terminated - Clinical trials for Atrial High Rate Episodes

Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes

NOAH
Start date: February 2016
Phase: Phase 3
Study type: Interventional

NOAH is an investigator-initiated, prospective, parallel-group, double-blind, randomised, multi-centre trial. The objective of the trial is to demonstrate that oral anticoagulation using the NOAC edoxaban is superior to current therapy to pre-vent stroke, systemic embolism, or cardiovascular death in patients with AHRE and at least two stroke risk factors but without AF. The trial will be conducted in several European countries.

NCT ID: NCT02616146 Terminated - Contraception Clinical Trials

Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring and Levonorgestrel-Ethinyl Estradiol Combined Oral Contraceptive in Adult Women at Risk for Pregnancy (MK-8342B-062)

Start date: December 1, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the contraceptive efficacy of the etonogestrel + 17β-estradiol (ENG-E2) vaginal ring in women between 18 and 35 years of age based on the number of in-treatment pregnancies as expressed by the Pearl Index (PI). The study will also assess the safety and tolerability of ENG-E2 vaginal ring. The levonorgestrel-ethinyl estradiol (LNG-EE) 150/30 μg combined oral contraceptive (COC) will be used as the active comparator.

NCT ID: NCT02615522 Terminated - Clinical trials for Osteoarthritis, Knee

Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration

Start date: September 2016
Phase:
Study type: Observational

Prospective, monocenter post market clinical follow-up of a primary knee replacement bearing the CE-mark. 200 subjects will be recruited and followed up for up to ten years or until revision of the primary knee endoprosthesis, whichever occurs first. Documentation of clinical and radiological parameters within the clinical routine pre-operative and post-operative at 3 and 12 months and 2, 5 and 10 years to evaluate time to revision, pain situation, knee functionality, mobility and stability.

NCT ID: NCT02612428 Terminated - Clinical trials for Acute Alcoholic Hepatitis

Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects w/ AILD

Start date: January 2016
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate safety and efficacy of ELAD with respect to overall survival of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) through at least Study Day 91. The secondary objective is to evaluate the proportion of survivors at Study Day 91 using a chi-squared test.