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NCT ID: NCT01631214 Completed - Clinical trials for Postmenopausal Women With Osteoporosis

Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

ARCH
Start date: May 4, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.

NCT ID: NCT01630434 Completed - Lung Preservation Clinical Trials

International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation

INSPIRE
Start date: November 2011
Phase: N/A
Study type: Interventional

A prospective, international, multi-center, randomized controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush and storage (Control Group).

NCT ID: NCT01628354 Completed - Clinical trials for Choroidal Neovascularization

Study to Investigate the Safety and Efficacy of Ranibizumab in Patients With Choroidal Neovascularisation Due to Causes Other Than Age Related Macular Degeneration

Start date: February 2008
Phase: Phase 4
Study type: Interventional

The investigators hypothesize that it is safe and effective to treat patients with choroidal neovascularisation (abnormal blood vessels growing under the retina) secondary to causes other than age related macular degeneration (AMD) and pigment epithelial detachments (blisters of fluid under the retina) secondary to AMD with ranibizumab (Lucentis). These groups of patients have to date been excluded from the multicentre trials demonstrating significant benefit of Ranibizumab in the treatment of AMD.

NCT ID: NCT01628094 Completed - Clinical trials for Hepatitis C, Chronic

ANNAPURNA: A Study of The Combination of RO5466731, RO5190591, Ritonavir and Copegus (Ribavirin) With or Without RO5024048 in Patients With Chronic Hepatitis C Who Are Either Treatment-Naïve or Have Previously Experienced a Null Response to Interferon-Based Treatment

Start date: June 2012
Phase: Phase 2
Study type: Interventional

This randomized, open-label, multicenter study will evaluate the safety , efficacy and tolerability of the combination treatment RO5466731, RO5190591, ritonavir and Copegus (ribavirin) with or without RO5024048 in patients with chronic hepatitis C genotype 1. In Part 1, treatment-naïve patients will be randomized to receive treatment with RO5466731, RO5190591 plus ritonavir, and Copegus, with or without RO5024048. In Part 2, further treatment-naïve patients will receive a successful regimen from Part 1, or a reduced intensity regimen, and patients who have previously experienced null response to interferon-based treatment will be added to the study.

NCT ID: NCT01627691 Completed - Clinical trials for Transcatheter Aortic Valve Replacement

REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System

Start date: October 8, 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

NCT ID: NCT01627340 Completed - Hepatitis B Clinical Trials

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus

Start date: July 24, 2012
Phase: Phase 4
Study type: Interventional

This study will evaluate the immunogenicity and safety of Engerix™-B (hepatitis B vaccine) when administered as a primary vaccination course at 0, 1 and 6 months in adults with or without type 2 diabetes mellitus.

NCT ID: NCT01626378 Completed - Clinical trials for Behavioral Variant Frontotemporal Dementia (bvFTD)

Safety and Efficacy Study Evaluating TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)

Start date: May 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the safety and efficacy of TRx0237 in the treatment of patients with behavioral variant frontotemporal dementia (bvFTD).

NCT ID: NCT01625390 Completed - Clinical trials for Hemophilia A, Hemophilia B

A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150

Start date: June 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Haemophilia is a disorder, usually genetic, affecting mostly male individuals, in which one of the proteins needed to form blood clots (FVIII) is missing or not present in sufficient levels. In a person with haemophilia, the clotting process is much slower and the person experiences bleeding episodes that can result in serious problems and potential disability. The current haemophilia standard of care is to maintain FVIII activity level above 1%. Sometimes, patients can develop antibodies (so called "inhibitors") against FVIII and it is no longer effective at controlling bleeds. Bleeds in these patients are currently treated using other proteins involved in the clotting process. The purpose of this study is to investigate how effectively BAY86-6150 may stop acute bleeds in "inhibitor" patients. This study consists of two parts, A and B. The purpose of part A is to find the most effective yet tolerable out of four doses of BAY86-6150 with regard to efficacy and safety (dose-finding part). Part A is expected to last 9 - 29 months. The purpose of part B is to confirm efficacy and safety of the dose found in part A in all participating patients (confirmatory part). Part B is expected to last 12-32 months. Approximately 60 male subjects 12 to 62 years-of-age with moderate or severe haemophilia A or B, with inhibitors to FVIII or FIX, who have had 4 or more bleeding episodes in the last 6 months, will participate in this study. Patient's bleeds will be treated with BAY86-6150 and with a rescue medication if no response is made to BAY86-6150. Patients will attend the treatment centre at regular intervals and be required to keep an electronic diary.

NCT ID: NCT01625338 Completed - Chronic Hepatitis C Clinical Trials

Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

Start date: June 2012
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).

NCT ID: NCT01625182 Completed - Clinical trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.

Start date: December 22, 2012
Phase: Phase 3
Study type: Interventional

The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.