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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: NCT00888433 Completed - Clinical trials for Uncontrolled Hypertension

Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)

HTN-2
Start date: June 2009
Phase: N/A
Study type: Interventional

An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.

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predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial.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 Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period.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: 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: NCT00880620 Completed - Parkinson's Disease Clinical Trials

A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease

APEX-PD
Start date: April 2009
Phase: Phase 3
Study type: Interventional

This study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease.

NCT ID: NCT00879970 Terminated - Clinical trials for Diabetes Mellitus, Type 2

Thiazolidinedione Intervention With Vitamin D Evaluation

TIDE
Start date: May 2009
Phase: Phase 4
Study type: Interventional

This study will answer two separate questions. The first question is to test the cardiovascular effects of long-term treatment with rosiglitazone or pioglitazone when used as part of standard of care compared to similar standard of care without rosiglitazone or pioglitazone in patients with type 2 diabetes who have a history of or are at risk for cardiovascular disease. The second question will compare the effects of long-term supplementation of vitamin D on death and cancer

NCT ID: NCT00870155 Terminated - Clinical trials for Secondary Progressive Multiple Sclerosis

A Study for Patients With Multiple Sclerosis

MAESTRO-02
Start date: February 2007
Phase: Phase 2/Phase 3
Study type: Interventional

To obtain additional safety data in subjects who have previously completed the MBP8298-01 study "A Double Blind Placebo Controlled Multi-Centre to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Multiple Sclerosis" Dirucotide is generic name for MBP8298.

NCT ID: NCT00869726 Completed - Clinical trials for Secondary Progressive Multiple Sclerosis

A Study for Patients With Secondary Progressive Multiple Sclerosis

MAESTRO-01
Start date: December 2004
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether MBP8298 is effective and safe in the treatment secondary progressive multiple sclerosis. Dirucotide is generic name for MBP8298.

NCT ID: NCT00860288 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Start date: February 2009
Phase: Phase 2/Phase 3
Study type: Interventional

This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as add-on therapy to metformin

NCT ID: NCT00858637 Completed - Clinical trials for Chronic Kidney Disease

Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis

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

The primary objective of this study is to demonstrate the superiority of MCI-196 over placebo and non-inferiority with simvastatin in reducing serum low-density lipoprotein (LDL)-cholesterol in subjects with chronic kidney disease Stage V on dialysis. This study incorporates a Washout Period and two treatment periods - an active comparison phase and a placebo-controlled withdrawal phase.