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NCT ID: NCT00559650 Terminated - Clinical trials for Congestive Heart Failure

Placebo Controlled, Randomized, Double-blind, Multi-center Study to Investigate the Efficacy and Tolerability of BAY58-2667

Start date: December 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess a dose titration scheme, of a new drug (BAY58-2667) given intravenously, to evaluate if this is safe and can help to improve the well-being, symptoms (e.g. breathing) and outcome of decompensated heart failure. Patients living with chronic heart failure have a risk of increased number of hospitalisations because of worsening of their condition (decompensated heart failure). The current treatment of acute heart failure consists of oxygen and medical treatment with vasodilators and positive inotropic agents (drugs, which should strengthen the pump function of the heart) which have their limitations. Therefore there is a need for new drugs in treatment of acute heat failure.

NCT ID: NCT00559286 Terminated - Clinical trials for Arterial Hypertension

Effect of the Known Antihypertensive Drug Telmisartan on Red Blood Cells and Circulation in the Smallest Blood Vessels

ITEM
Start date: December 2007
Phase: Phase 4
Study type: Interventional

The hypothesis of the presented study is: Telmisartan induces an increase of eNOS activity in RBC resulting in an enhanced intravascular NO bioavailability, an ameliorated RBC deformability and a reduction of RBC and platelet aggregation. This could be a potential mechanism of the improvement of microcirculatory disorders, especially in patients with diabetes mellitus and arterial hypertension, treated with Telmisartan.

NCT ID: NCT00557921 Terminated - Clinical trials for Coronary Artery Disease

Clopidogrel and the Optimization of Gastrointestinal Events (COGENT-1)

COGENT-1
Start date: December 2007
Phase: Phase 3
Study type: Interventional

The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of gastrointestinal bleeding and symptomatic ulcer disease, in the setting of concomitant aspirin therapy. Antiplatelet therapy is an essential element of care for patients with atherothrombotic disease. Bleeding is a fundamental adverse effect of all antiplatelet drugs including aspirin, clopidogrel and dual antiplatelet regimens. The gastrointestinal tract is the most common site of bleeding related to antiplatelet therapy, typically in connection with peptic ulcer disease. Recently published studies suggest the use of clopidogrel carries a gastrointestinal bleeding risk similar to that of aspirin or non-aspirin non-steroidal anti-inflammatory drugs. Patients taking any two of these drugs (clopidogrel, aspirin and/or non-aspirin NSAIDs) are exposed to an even higher risk of bleeding and ulcer disease. Cogentus Pharmaceuticals is launching phase 3 trials of a novel combination product, CGT-2168, which has the potential to significantly reduce this problem and increase patient safety. CGT-2168 combines a standard dosage of clopidogrel and a gastroprotectant (omeprazole) in a once-daily pill that may reduce the likelihood of adverse gastrointestinal events.

NCT ID: NCT00555789 Terminated - Clinical trials for Kidney Transplantation

24 Month Extension to Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients(Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients

Start date: October 2007
Phase: Phase 2
Study type: Interventional

This study will provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.

NCT ID: NCT00555321 Terminated - Clinical trials for Immunosuppression in Solid Organ Transplant

Belatacept in Liver Transplant Recipients

Start date: January 2008
Phase: Phase 2
Study type: Interventional

The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant

NCT ID: NCT00551785 Terminated - Hysterectomy Clinical Trials

Surveillance Study of Women Taking Intrinsa®

EMPOWER
Start date: September 2007
Phase: Phase 4
Study type: Observational

The primary objective of the study is to assess the risks of testosterone transdermal patch use in a representative study population. The primary clinical outcome of interest is breast cancer.

NCT ID: NCT00550862 Terminated - Clinical trials for Liver Cirrhosis, Biliary

Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)

Start date: October 2007
Phase: Phase 2
Study type: Interventional

The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to placebo.

NCT ID: NCT00550420 Terminated - Alzheimer's Disease Clinical Trials

Study Of Rosiglitazone XR In Subjects With Mild-to-Moderate Alzheimers

Start date: October 1, 2007
Phase: Phase 3
Study type: Interventional

This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed AVA105640. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study followed by 8mg RSG XR. Subject participation will last until one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this study is to evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD who have completed AVA105640. The secondary objective of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele status

NCT ID: NCT00550004 Terminated - Pancreatic Cancer Clinical Trials

Phase II Study to Evaluate Efficacy and Safety of RP101 in Combination With Gemcitabine

RP101
Start date: September 2007
Phase: Phase 2
Study type: Interventional

This will be a Phase II, multicenter, randomized, double blind, placebo controlled, study of six 28-day treatment cycles for patients with locally advanced, unresectable, or metastatic pancreatic cancer. The study will be conducted at approximately 55 sites in the North American, Europe, and South America. Approximately 153 subjects will be enrolled in a randomization (ratio 2:1).

NCT ID: NCT00549757 Terminated - Clinical trials for Type 2 Diabetes Mellitus

Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)

ALTITUDE
Start date: October 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney. AMENDMENT 4 RATIONALE (MARCH 2012) : Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.