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NCT ID: NCT00890448 Completed - Toxicity Clinical Trials

Case Control Study of Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure to Lapaquistat Acetate

Start date: May 2009
Phase: N/A
Study type: Observational

The purpose of this study is to examine the genetic contribution to the mechanism of lapaquistat acetate- induced hepatic abnormalities.

NCT ID: NCT00887224 Completed - Clinical trials for Major Depressive Disorder

Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder

Start date: June 2009
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to compare the long-term efficacy and safety of desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive Disorder, using a randomized withdrawal design. Randomized withdrawal means that after receiving desvenlafaxine succinate sustained release for a predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial. Subjects will not know to which group they have been assigned. The study consists of an up to 14-day screening period followed by an 8-week open-label period in which subjects will knowingly receive 50 mg/day of desvenlafaxine succinate sustained release. Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period. Responding subjects will receive an additional 3 months of open-label desvenlafaxine succinate sustained release at the same dose. Subjects with stable response to treatment at the conclusion of this 3 month period will be randomized to either desvenlafaxine succinate sustained release at 50 mg/day or placebo in a blinded manner for an additional 6 months or until symptoms of depression return. Following discontinuation at any point after enrollment in the study, subjects will receive two weeks of follow-up monitoring, including one week of blinded taper with 25 mg/day of desvenlafaxine succinate sustained release treatment for any subjects who have been taking desvenlafaxine succinate sustained release prior to discontinuation. Subjects assigned to placebo will receive a blinded placebo taper. Following taper, subjects will be evaluated for one additional week to monitor safety.

NCT ID: NCT00884507 Completed - Alzheimer's Disease Clinical Trials

A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease

Start date: May 2009
Phase: Phase 2
Study type: Interventional

This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534 1mg, 5mg or 15mg po daily) with background therapy of donepezil (5mg or 10mg).The anticipated time on study treatment is 6 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00882999 Completed - Clinical trials for Relapsing-Remitting Multiple Sclerosis

A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)

Start date: April 2009
Phase: Phase 2
Study type: Interventional

To look at the ability of LY2127399 to reduce magnetic resonance imaging (MRI) lesions at 12, 16, 20, and 24 weeks compared to placebo.

NCT ID: NCT00882778 Completed - Clinical trials for Congenital Bleeding Disorder

PROPACT: Retrospective Prophylaxis Patient Case Collection

PROPACT
Start date: April 2009
Phase: N/A
Study type: Observational

This study is conducted in Europe and North and South America. The primary aim of this observational study is to evaluate the frequency and pattern of bleeding episodes in haemophilia patients receiving preventative treatment with activated recombinant human factor VII. The secondary aim is to evaluate which patients are selected for this treatment, the dose and dose intervals used, and the safety of activated recombinant human factor VII when used as prevention. The study also aims to increase understanding of the unmet medical need and clinical relevance of preventative treatment in haemophilia patients.

NCT ID: NCT00881530 Completed - Clinical trials for Diabetes Mellitus, Type 2

Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

Start date: March 2009
Phase: Phase 2
Study type: Interventional

The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.

NCT ID: NCT00878709 Completed - Breast Cancer Clinical Trials

Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

ExteNET
Start date: July 9, 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.

NCT ID: NCT00878527 Completed - Heart Failure Clinical Trials

Safety and Performance Evaluation of CircuLite Synergy

Start date: June 29, 2007
Phase: N/A
Study type: Interventional

The purpose of the study is to demonstrate the safety and functionality of the CircuLite Synergy Pocket Circulatory Assist Device.

NCT ID: NCT00877929 Completed - Hypertension Clinical Trials

Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus

Start date: February 2009
Phase: Phase 3
Study type: Interventional

To demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure.

NCT ID: NCT00877383 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease

INTRUST2
Start date: April 2009
Phase: Phase 3
Study type: Interventional

This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD).