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NCT ID: NCT00801060 Terminated - Clinical trials for Chronic Lymphocytic Leukemia

Evaluation of Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) +/- Lumiliximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Start date: February 2008
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, open-label, multicenter study in subjects with previously untreated CLL. It is designed to evaluate safety and efficacy of fludarabine, cyclophosphamide, rituximab (FCR) and lumiliximab versus FCR alone.

NCT ID: NCT00800683 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive

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

to determine safety, efficacy and tolerability of BI 1356 versus placebo

NCT ID: NCT00800579 Completed - Cystic Fibrosis Clinical Trials

Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male Volunteers

Start date: November 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of escalating doses of GS-9411 in healthy male volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway hydration and mucociliary clearance in the lung.

NCT ID: NCT00800436 Completed - Breast Cancer Clinical Trials

A Dose Finding Study of Subcutaneous Herceptin (Trastuzumab) in Healthy Male Volunteers and HER2 Positive Female Patients

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

This 2 part study will select the subcutaneous(sc) dose of Herceptin which results in comparable exposure to intravenous(iv) Herceptin in healthy male volunteers and in HER2 positive female patients, and will assess the safety and tolerability of the 2 formulations. In the first part of the study, 4 cohorts of subjects will be treated with a single dose of Herceptin as follows: Cohort 1--6mg/kg iv in healthy male volunteers; Cohort 2--6mg/kg iv in female patients; Cohort 3--6mg/kg sc in healthy male volunteers; Cohort 4 --10mg/kg sc in healthy male volunteers. In part 2 of the study, the chosen sc dose (<12mg/kg)will be confirmed in female patients. Patients will receive a maximum of 2 doses of Herceptin, and the target sample size is <100 individuals.

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: NCT00800176 Completed - Clinical trials for Diabetes Mellitus Type 2

A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus

Start date: January 22, 2009
Phase: Phase 2
Study type: Interventional

This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg po daily, or placebo daily. Patients pre-treated with stable metformin will continue to take their usual dose of metformin throughout the study.The anticipated time on study treatment is <=3 months

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.

NCT ID: NCT00799266 Completed - Osteoporosis Clinical Trials

An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids

Start date: December 4, 2008
Phase: Phase 3
Study type: Interventional

This study was designed to evaluate the efficacy and safety of zoledronic acid compared to placebo in osteoporotic children treated with glucocorticoids

NCT ID: NCT00799227 Completed - Clinical trials for Diabetic Macular Edema

Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema

Start date: January 1, 2009
Phase: Phase 2
Study type: Interventional

The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.

NCT ID: NCT00798993 Completed - Clinical trials for End Stage Kidney Disease

Effect of 25-hydroxyvitamin D and a Structured Exercise Program on Dialysis Patients

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

This study aims to examine the effect of 25 hydroxyvitamin D supplementation and a structured exercise program on the exercise capacity and quality of life of haemodialysis patients with 25 hydroxyvitamin D insufficiency.