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NCT ID: NCT00501566 Completed - Liver Cirrhosis Clinical Trials

Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites

Normo~CAT
Start date: April 2004
Phase: Phase 2
Study type: Interventional

The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites when used concomitantly with a standard dose regimen of spironolactone and furosemide. The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.

NCT ID: NCT00501384 Completed - Liver Cirrhosis Clinical Trials

Satavaptan Dose-Ranging Study in the Prevention of Ascites

SPA
Start date: April 2004
Phase: Phase 2
Study type: Interventional

The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone. The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period. This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).

NCT ID: NCT00501046 Completed - Clinical trials for Chronic Kidney Disease

A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease Including Assessment of Quality of Life (EPPIC-2)

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

1) To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD), on time to first occurrence of any event of the triple composite outcome of initiation of dialysis, kidney transplant or doubling of serum creatinine (sCr) when compared with placebo; 2) To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD; 3) To evaluate the effects of AST-120 versus placebo, on other measures of renal function and quality of life.

NCT ID: NCT00500682 Completed - Clinical trials for Chronic Kidney Disease

A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease (EPPIC-1)

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

1) To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD), on time to first occurrence of any event of the triple composite outcome of initiation of dialysis, kidney transplant or doubling of serum creatinine (sCr) when compared with placebo; 2) To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD; 3) To evaluate the effects of AST-120 versus placebo, on other measures of renal function.

NCT ID: NCT00500539 Completed - Asthma Clinical Trials

Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.

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

The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patients). The secondary objective of this study is to assess the safety of the liquid formulation of omalizumab in the same patients.

NCT ID: NCT00500331 Completed - Clinical trials for Diabetes Mellitus, Type 2

Dose-Ranging Study in Treatment Naive Type 2 Diabetes Mellitus(T2DM)

Start date: January 23, 2007
Phase: Phase 2
Study type: Interventional

This is a dose-ranging study that will evaluate the efficacy, safety and tolerability of a range of doses of investigational product and pioglitazone, compared to placebo, administered as monotherapy over 12 weeks in treatment naive patients with T2DM

NCT ID: NCT00496938 Completed - Clinical trials for Coronary Artery Disease

XIENCE V: SPIRIT WOMEN

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

The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIMEā„¢ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

NCT ID: NCT00496769 Completed - Atrial Fibrillation Clinical Trials

A Phase III Study of Apixaban in Patients With Atrial Fibrillation

AVERROES
Start date: August 31, 2007
Phase: Phase 3
Study type: Interventional

The purpose of this clinical research study is to determine whether apixaban is more effective than acetylsalicylic acid in the prevention of strokes associated with patients with atrial fibrillation. The safety of this treatment will also be studied.

NCT ID: NCT00496158 Terminated - Hepatitis B Clinical Trials

Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus

QUASH2
Start date: August 2007
Phase: Phase 3
Study type: Interventional

The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks, 72 weeks, and 96 weeks.

NCT ID: NCT00496002 Terminated - Hepatitis B Clinical Trials

Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus

QUASH 1
Start date: August 2007
Phase: Phase 3
Study type: Interventional

The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks and 96 weeks.