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NCT ID: NCT00803855 Completed - Healthy Clinical Trials

Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy Volunteers

SAD
Start date: December 2008
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to assess the safety and tolerability of AZD1446 following single dose administration.

NCT ID: NCT00803205 Completed - Cystic Fibrosis Clinical Trials

Study of Ataluren (PTC124™) in Cystic Fibrosis

Start date: September 8, 2009
Phase: Phase 3
Study type: Interventional

Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of mutation called a nonsense (premature stop codon) mutation is the cause of CF in approximately 10% of patients with the disease. Ataluren is an orally delivered investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 3 trial that will evaluate the clinical benefit of ataluren in adult and pediatric participants with CF due to a nonsense mutation. The main goals of the study are to understand whether ataluren can improve pulmonary function and whether the drug can safely be given for a long period of time. The study will also assess the effects of ataluren on CF pulmonary exacerbation frequency, cough frequency, health-related quality of life, antibiotic use for CF-related infections, CF-related disruptions to daily living, body weight, and CF pathophysiology.

NCT ID: NCT00803049 Completed - Multiple Sclerosis Clinical Trials

Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis

Start date: October 2006
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) patients with relapse. The secondary objective is to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI) parameters.

NCT ID: NCT00802750 Completed - Catheterization Clinical Trials

Study Where Healthy Volunteers Evaluate LoFric Catheters

Start date: November 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate healthy volunteers perception of catheterization with LoFric catheters with new solvents in the manufacturing process. The subjects will be catheterized three times during one visit day. The hypothesis is that the subjects' perception of catheterization is the same when using the test catheters compared to the reference catheter.

NCT ID: NCT00802737 Completed - Clinical trials for Leukaemia, Lymphocytic, Chronic

Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL)

Start date: January 2009
Phase: Phase 4
Study type: Interventional

The purpose of the trial is to investigate the efficacy and safety of ofatumumab retreatment and maintenance in patients with chronic lymphocytic leukemia who have previously responded or had disease stabilization after ofatumumab in an ongoing trial (Hx-CD20-406).

NCT ID: NCT00802373 Completed - Clinical trials for Urinary Bladder, Overactive

Solifenacin Succinate Versus Tolterodine 4mg Once Daily

STAR
Start date: July 2003
Phase: Phase 3
Study type: Interventional

Prospective, double-blind, double-dummy, 2-arm, parallel-group, design. Flexible dose regimen for solifenacin succinate, fixed dose treatment regimen for tolterodine. Assessment of OAB symptoms by patient diaries.

NCT ID: NCT00801424 Completed - Hypothermia Clinical Trials

Warmed Humidified Carbon Dioxide (CO2) for Open Surgery

S2
Start date: November 2008
Phase: N/A
Study type: Interventional

Eighty adult patients undergoing open colon surgery will be randomized to either: 1. standard warming measures including heating sheets, warming of fluids, and insulation of limbs and head, or to 2. additional insufflation of humidified carbon dioxide (approx. 36-37ºC, approx. 80-100% relative humidity) via a humidifier with a heated tube (Fisher&Paykel) connected to a gas diffuser (Cardia Innovation AB) that is able to create a local atmosphere of 100% carbon dioxide (humidified ) in the open wound cavity. PRIMARY AIM The primary aim of this study is to evaluate if humidified carbon dioxide insufflated into an open surgical wound can be used to warm the core, the open wound cavity, and the wound edges during major abdominal surgery. SECONDARY AIMS Secondary aims are to evaluate possible differences between the groups regarding complications and clinical differences including histological signs of desiccation injury of peritoneal samples, time to extubation, core temperature after surgery, ICU stay, bleeding volume, hospital stay, postoperative pain, infections, shivering, postoperative signs of restored bowel function including bowel movements, flatus, and first meal.

NCT ID: NCT00800384 Completed - Clinical trials for Ventricular Tachycardia

Shockless Implant Evaluation

SIMPLE
Start date: January 2009
Phase: N/A
Study type: Interventional

This trial will assess the safety of defibrillator testing and the influence of defibrillation testing on the efficacy of clinical shocks. The trial will test the hypothesis that implantable cardioverter defibrillator (ICD) implantation without defibrillation testing (DT) is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death. It will also test the hypothesis, that defibrillation testing increases the peri-operative (30 days) complication rate of ICD implantation.

NCT ID: NCT00799981 Completed - Catheterization Clinical Trials

A Comparison of Two Urinary Catheters of Different Lengths for Female Use, in Intermittent Catheterization

Start date: November 2008
Phase: N/A
Study type: Interventional

A study comparing a 10 cm catheter with a 7 cm catheter in a group of female patients who, on a routine bases, empty their bladder using urinary catheters, by measuring residual urine after intermittent catheterization.

NCT ID: NCT00799903 Completed - Atherosclerosis Clinical Trials

The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial

STABILITY
Start date: December 2008
Phase: Phase 3
Study type: Interventional

This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.