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NCT ID: NCT00721760 Completed - Clinical trials for Venous Thromboembolism

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery

SAVE-HIP2
Start date: July 2008
Phase: Phase 3
Study type: Interventional

The primary objective was to compare the efficacy of once daily [q.d] subcutaneous [s.c.] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the prevention of Venous Thromboembolic Events [VTE] in patients undergoing hip fracture surgery. The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing hip fracture surgery, and to document AVE5026 exposure in this population.

NCT ID: NCT00718549 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

A Study to Assess the Effect of Maintenance Treatment With Rituximab Versus No Treatment in Participants With Progressive B-Cell Chronic Lymphocytic Leukemia (CLL)

Start date: July 21, 2009
Phase: Phase 3
Study type: Interventional

This study will assess the effect of maintenance treatment with rituximab in comparison with observation period (no treatment), in participants with progressive B-cell CLL who have had previous first-line induction treatment with rituximab, cladribine and cyclophosphamide (RCC regimen). After 6 months of RCC induction therapy, participants will be randomized either to receive maintenance treatment with rituximab or to receive no treatment (observation only) for 96 weeks. Participants completing maintenance/observation period will be followed-up for approximately 3 years.

NCT ID: NCT00718224 Completed - Clinical trials for Venous Thromboembolism

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Elective Knee Replacement Surgery

SAVE-KNEE
Start date: July 2008
Phase: Phase 3
Study type: Interventional

The primary objective was to compare the efficacy of Semuloparin sodium (AVE5026) with Enoxaparin for the prevention of Venous Thromboembolic Events [VTE] in patients undergoing elective knee replacement surgery. The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing elective knee replacement surgery, and to document AVE5026 exposure in this population.

NCT ID: NCT00709904 Completed - Clinical trials for Venous Thromboembolism

Evaluation of AVE5026 as Compared to Placebo for the Extended Prophylaxis of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery

SAVE-HIP3
Start date: June 2008
Phase: Phase 3
Study type: Interventional

The primary objective is to evaluate the efficacy of once daily (QD) subcutaneous (SC) injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following an initial 7 to 10-day venous thromboprophylaxis with open-label AVE5026 in patients having undergone hip fracture surgery. The secondary objective is to evaluate the safety of extended AVE5026 administration.

NCT ID: NCT00708435 Completed - Clinical trials for Blood Coagulation Disorders

Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy

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

The purpose of this study is to evaluate efficacy, safety and tolerance of BERIPLEX® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by coumarin derivatives in subjects who require immediate correction of INR (International Normalized Ratio)and to stop an acute major bleeding.

NCT ID: NCT00697099 Completed - Clinical trials for Venous Thromboembolism

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Total Hip Replacement Surgery

SAVE-HIP1
Start date: June 2008
Phase: Phase 3
Study type: Interventional

The primary objective was to compare the efficacy of once daily [q.d.] subcutaneous [s.c.] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of enoxaparin for the prevention of Venous Thromboembolic Events [VTE] in patients undergoing elective total hip replacement surgery. The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing elective total hip replacement surgery, and to document AVE5026 exposure in this population.

NCT ID: NCT00694382 Completed - Cancer Clinical Trials

Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy

SAVE-ONCO
Start date: June 2008
Phase: Phase 3
Study type: Interventional

The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism [VTE] in cancer patients at high risk for VTE and who were undergoing chemotherapy. The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.

NCT ID: NCT00689104 Completed - Clinical trials for Urinary Bladder, Overactive

Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

SCORPIO
Start date: April 28, 2008
Phase: Phase 3
Study type: Interventional

The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.

NCT ID: NCT00688688 Completed - Clinical trials for Urinary Bladder, Overactive

Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

TAURUS
Start date: April 25, 2008
Phase: Phase 3
Study type: Interventional

The study is intended to test the safety, tolerability, efficacy of two doses of long term once daily (qd) treatment of Mirabegron in patients with symptoms of overactive bladder and secondly to compare these with active comparator.

NCT ID: NCT00680550 Completed - Atrial Fibrillation Clinical Trials

INSIGHT (R)XT. Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT

Start date: April 2008
Phase: N/A
Study type: Observational

To describe the clinical indications for Reveal XT in diagnosis and continuous monitoring of arrhythmia and to explore the clinical applications and outcome of arrhythmia monitoring on patient care.