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NCT ID: NCT00605683 Completed - Clinical trials for Idiopathic Parkinson's Disease

MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist

MOTION
Start date: November 2007
Phase: Phase 3
Study type: Interventional

Parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO B, the major DA metabolising enzyme in man. This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinson's Disease. The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score from baseline to endpoint, was chosen based on regulatory guidance and prior use in other trials in similar populations.

NCT ID: NCT00603746 Completed - Asthma Clinical Trials

A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Moderate-Dose ICS Therapy.

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

This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

NCT ID: NCT00603525 Terminated - Clinical trials for Arthritis, Rheumatoid

Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-α Antagonist Therapy

Start date: January 2008
Phase: Phase 3
Study type: Interventional

This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a duration of 24 weeks, followed by a 120 week Open-label Period. The primary purpose of the study is to demonstrate the efficacy and safety of ofatumumab in reducing clinical signs and symptoms in adult RA patients who had an inadequate response to TNF-α antagonist therapy.

NCT ID: NCT00603382 Completed - Asthma Clinical Trials

A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Non-steroidal Therapy.

Start date: December 1, 2007
Phase: Phase 2
Study type: Interventional

This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

NCT ID: NCT00602745 Terminated - Neoplasm Metastasis Clinical Trials

S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen

S-1 Pancreas
Start date: February 2008
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy. The secondary objectives are to compare: progression free survival, overall response rate, clinical benefit and improvement in tumor related symptoms and also to assess overall safety and pharmacokinetics of S-1.

NCT ID: NCT00600171 Completed - Asthma Clinical Trials

Efficacy And Safety Of GW642444M Comparing Placebo In Adolescent And Adult Subjects With Persistent Asthma.

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

This study is designed to determine if the investigational drug is effective and safe in individuals with asthma

NCT ID: NCT00591578 Completed - Hypertension Clinical Trials

Efficacy and Safety Comparison of Azilsartan Medoxomil to Valsartan in Participants With Essential Hypertension

Start date: December 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of TAK-491 (azilsartan medoxomil), once daily (QD), to valsartan in participants with essential hypertension.

NCT ID: NCT00589264 Completed - Child Development Clinical Trials

Zinc and Biobehavioral Development in Early Childhood

Start date: July 2004
Phase: N/A
Study type: Interventional

Zinc is necessary for growth and development, including the central nervous system, and zinc deficiency which is common in resource-poor settings, may adversely affect social, behavorial, cognitive and sensorimotor development. The project, located in Lima Peru, utilizes an experimental model in which children receive 10 mg supplemental zinc (or not) daily along with 10 mg iron and 1/2 mg copper from 6 months of age to 18 months of age. Beginning at 6 months of age, and at 9, 12, and 18 months, children are evaluated in multiples aspects of development. Children are also followed for their diet, growth, and health status. We hypothesize that children in this setting in which the diet is low in zinc who receive supplemental zinc will have better information processing skills, sensorimotor and behavioral development than their counterparts who do not receive supplemental zinc.

NCT ID: NCT00580216 Terminated - Atrial Fibrillation Clinical Trials

Evaluation of Weekly Subcutaneous Biotinylated Idraparinux Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation

BOREALIS-AF
Start date: December 2007
Phase: Phase 3
Study type: Interventional

The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial fibrillation (AF).

NCT ID: NCT00579306 Completed - Stroke Clinical Trials

Levels of Inflammatory Markers in the Treatment of Stroke—An SPS3 Ancillary Study

LIMITS
Start date: June 2005
Phase: N/A
Study type: Observational

The goals of this trial are to determine the prognostic significance of an elevated level of inflammatory blood markers in people who have experienced small subcortical strokes and who are enrolled in the Secondary Prevention of Small Subcortical Strokes (SPS3) trial.