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NCT ID: NCT00327691 Completed - Clinical trials for Cardiovascular Disease

A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels

TNT
Start date: April 1998
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to determine the degree of additional reduction in cardiovascular risk that was accrued to patients by lowering their LDL-C beyond the currently accepted minimum target level for patients with pre-existing CHD. Secondary objectives include the safety profile of this treatment strategy, its cost-effectiveness, effect on other atherosclerotic-related events and procedures, and total mortality.

NCT ID: NCT00327665 Completed - Clinical trials for Infections, Streptococcal

Study to Evaluate the Safety and Immunogenicity of an Investigational Pneumococcal Vaccine in the Elderly Population

Start date: May 1, 2006
Phase: Phase 1
Study type: Interventional

As the licensed pneumococcal vaccine is not always satisfactory in elderly, new investigational pneumococcal vaccines are evaluated in the healthy elderly population. Note: The study consists of the primary phase (106068): vaccination and follow-up and the extension (106072) of the primary phase: 1 year follow-up. This protocol posting details the procedures of both the primary & extension phase.

NCT ID: NCT00327535 Completed - Anemia Clinical Trials

A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.

Start date: May 2006
Phase: Phase 2
Study type: Interventional

This 4 arm study will assess the optimal starting dose of Mircera in the treatment of anemia in patients with non-small cell lung cancer receiving first line myelosuppressive chemotherapy. Patients will be randomized to receive either Mircera 6.3 micrograms/kg, 9 micrograms/kg or 12 micrograms/kg s.c. every 3 weeks or darbepoetin alfa according to the approved local label (either 6.75 micrograms/kg s.c. every 3 weeks, or 2.25 micrograms/kg every week). The anticipated time on study treatment is <3 months and the target sample size is 100-500 individuals.

NCT ID: NCT00327522 Completed - Clinical trials for Prophylactic Pneumococcal Diseases

Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.

Start date: June 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of two doses of GSK Biologicals' 11 PCV vaccine when given to healthy subjects aged 18 to 40 years .

NCT ID: NCT00327444 Completed - Ovarian Neoplasms Clinical Trials

Study of the Effect of Intravenous AVE0005 (VEGF Trap) in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites

Start date: July 2006
Phase: Phase 2/Phase 3
Study type: Interventional

This study was designed to characterize the effect of aflibercept in participants with advanced chemoresistant ovarian cancer. Primary objective: Compare the effect of aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) to placebo treatment on repeat paracentesis in symptomatic malignant ascites in participants with advanced ovarian cancer Secondary objectives: Safety, tolerability, paracentesis-related parameters, participant-reported outcome.

NCT ID: NCT00326976 Completed - Clinical trials for Myocardial Infarction

Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury

Start date: August 2006
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate whether FX06 is capable of limiting infarct size following balloon catheterization for acute myocardial infarction.

NCT ID: NCT00326625 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)

Start date: July 27, 2006
Phase: Phase 2
Study type: Interventional

Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting multiple sclerosis. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties, which are believed to be of therapeutic value in ALS. The study treatment duration is 1 year (52 weeks).

NCT ID: NCT00325442 Completed - Clinical trials for Pulmonary Hypertension

FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)

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

This study was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16. Patients who completed all assessments for 16-weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).

NCT ID: NCT00325403 Completed - Clinical trials for Pulmonary Hypertension

FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)

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

This study was an international, multicenter, randomized (2:1 active:placebo), double-blind, placebo-controlled study in subjects with PAH who were NOT currently receiving approved therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and Week 12. Patients who completed all assessments for 12 weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).

NCT ID: NCT00325169 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

SERETIDE Plus Tiotropium Versus Individual Components

Start date: December 2005
Phase: Phase 2
Study type: Interventional

This study was designed to evaluate the effects on lung function of a combination of SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg once daily alone and SERETIDE 50/500mcg twice daily alone) in subjects with COPD. The study will utilise a three-way cross-over design with a 2-week wash-out period between each 2-week consecutive treatment period.