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NCT ID: NCT00468975 Completed - Asthma Clinical Trials

A Blinded Study To Examine The Ability Of PF-610,355 To Open The Airways In Asthmatic Patients.

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

A study to determine the ability of different doses of PF-610,355 to open the airways in asthmatic patients by comparison with placebo and a marketed drug that also opens the airways in asthmatic patients.

NCT ID: NCT00468845 Completed - Pain, Postoperative Clinical Trials

Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy

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

To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of pain.

NCT ID: NCT00468832 Active, not recruiting - Clinical trials for Duchenne Muscular Dystrophy

Longitudinal Study of the Natural History of Duchenne Muscular Dystrophy (DMD)

Start date: December 2005
Phase: N/A
Study type: Observational

The purpose of this study is to establish the largest long-term assessment of people with Duchenne muscular dystrophy (DMD). In this study, the investigators associated with the Cooperative International Neuromuscular Research Group CINRG) will take a detailed look (for a minimum of eight years) at DMD participant's physical abilities, the medical problems they experience, and how they use health care services. Physical abilities will be compared to a group of healthy controls. The second purpose of this study is to find out whether small, normal differences in the genetic makeup of people with DMD (called "single nucleotide polymorphisms" or "SNPs") affect how their disease progresses and relates to muscle strength/size and steroid response. The third purpose of this study is to study genetic variations associated with DMD. The final purpose of this study is to determine whether certain biomarkers are present in people with DMD and not in healthy controls.

NCT ID: NCT00468819 Completed - Clinical trials for Magnetic Resonance Imaging

A Study of Magnetic Resonance Imaging (MRI) With Gadavist in Children

Start date: May 2007
Phase: Phase 1
Study type: Interventional

In this clinical study a contrast agent for magnetic resonance imaging (MRI), which has already been approved for application in adults, will be investigated in children and adolescents. MRI is a modern and safe examination method without delivering radiation burden using magnetic fields to produce cross-sectional images of the human body. A special computer program then puts these images together and creates a two or three-dimensional image of the inner organs thus facilitating the detection and evaluation of pathological changes. In contrast-enhanced MRI a contrast agent is injected into a peripheral vein before the examination which results in a stronger contrast in the examined area. Therefore, pathological changes can be more easily detected and evaluated compared to non-enhanced MRI. The company Bayer HealthCare Pharmaceuticals has developed a contrast agent for MRI called Gadavist 1.0 which was first approved in 1998 in Switzerland for MRI of brain and spine. Since 2003 Gadavist can also be used in magnetic resonance angiography (MRA) in adults, i.e. in the MRI examination of the blood vessels and since 2006 in MRI of liver and kidney disease. Gadavist was examined in more than 2,900 adults within the framework of clinical studies during development and has been used after its marketing authorization in meanwhile more than 600,000 patients. Yet, clinical studies investigating Gadavist have been only conducted with adults so far. Diseases requiring MRI examinations, however, often occur in children, too. Therefore, many contrast agents are already used on a regular basis in MRI examinations of children, some of these contrast agents being authorized already. Within the framework of this study the pharmacokinetic characteristics of Gadavist in children or adolescents will be investigated, i.e. how the contrast agent is distributed and behaves in the body. In addition, safety and tolerability will be evaluated in order to demonstrate that Gadavist 1.0 is a safe and well tolerated contrast agent also for children and adolescents. Furthermore, the study aims to obtain the dosage recommendation of 0.1 ml per kilogram body weight also for this population group.

NCT ID: NCT00468767 Completed - Atrial Fibrillation Clinical Trials

Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation

ACT I
Start date: August 2003
Phase: Phase 3
Study type: Interventional

This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.

NCT ID: NCT00468728 Completed - Diarrhea Clinical Trials

PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

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

This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

NCT ID: NCT00466167 Completed - Parkinson Disease Clinical Trials

Pivotal Study in Advanced Parkinsons Disease Patients

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

The general aim of this trial is to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for Unified Parkinsons Disease Rating Scale Parts II and III combined), safety, and tolerability of pramipexole ER, in daily doses from 0.375 milligram to 4.5 milligram once a day, in comparison to placebo, in Levodopa combined with a Dopa-Decarboxylase-inhibitor treated Parkinson patients with advanced Parkinsons Disease and motor fluctuations. In addition, a numerical comparison of the efficacy of pramipexole extended release versus pramipexole immediate release will be done. The efficacy of pramipexole immediate release will also be compared to placebo, for assay sensitivity.

NCT ID: NCT00465816 Completed - Clinical trials for Infections, Meningococcal

Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612

Start date: April 11, 2007
Phase: Phase 3
Study type: Interventional

This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years. There will be 3 groups in this study.

NCT ID: NCT00464165 Completed - Smoking Cessation Clinical Trials

Comparison of Efficacy and Safety of Rimonabant 5mg/Day or 20mg/Day Versus Placebo in Smoking Cessation

STRATUS-EU
Start date: November 2002
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers. The secondary objective is to evaluate the effects of rimonabant on craving and weight and on the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period and to observe the percentage of abstinent subjects during a 40-week follow-up post treatment.

NCT ID: NCT00463866 Completed - Asthma Clinical Trials

Local Phase 4 Pan-European SMART Study

Start date: March 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period