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NCT ID: NCT00566657 Completed - Clinical trials for Peripheral Vascular Diseases

Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions

TAMARIS
Start date: November 2007
Phase: Phase 3
Study type: Interventional

Primary objective is to demonstrate the superiority of riferminogene pecaplasmid over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin lesions. Secondary objectives are to evaluate: - The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major amputation; - The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death; - The safety of riferminogene pecaplasmid in the study population.

NCT ID: NCT00566254 Completed - Clinical trials for Epilepsy; Paediatric Partial Onset Seizures

Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Study)

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

The purpose of this study is to compare the safety and efficacy of zonisamide with placebo.

NCT ID: NCT00561470 Completed - Clinical trials for Colorectal Neoplasms

Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen

VELOUR
Start date: November 2007
Phase: Phase 3
Study type: Interventional

The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin based treatment for metastatic disease. The secondary objectives were to compare progression-free survival, to evaluate overall response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV) aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.

NCT ID: NCT00558363 Completed - Neoplasms, Prostate Clinical Trials

ARTS - AVODART After Radical Therapy For Prostate Cancer Study

ARTS
Start date: November 2007
Phase: Phase 2
Study type: Interventional

ARI109924 will be a 2-year, multicentre, randomised, double-blind, placebo-controlled trial assessing the efficacy and safety of dutasteride in extending time to prostate specific antigen (PSA) doubling in men who have been treated for clinically localised prostate cancer (PCa) with a radical therapy (radical prostatectomy, primary radiotherapy or salvage radiotherapy) with curative intent but who experience a biochemical failure (PSA rise) afterwards without signs or symptoms of metastases.

NCT ID: NCT00558259 Completed - Clinical trials for Venous Thromboembolism

Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE

RE-SONATE
Start date: November 2007
Phase: Phase 3
Study type: Interventional

The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA).

NCT ID: NCT00552344 Completed - Crohn Disease Clinical Trials

A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease

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

The primary objective of the study is to assess the safety of long term therapy with Certolizumab Pegol in those subjects participating in study C87085 [NCT00552058].

NCT ID: NCT00552058 Completed - Crohn Disease Clinical Trials

Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease

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

The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.

NCT ID: NCT00551707 Completed - Clinical trials for Rheumatoid Arthritis

Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis

MARS-1
Start date: October 2007
Phase: Phase 2
Study type: Interventional

CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating the dose-dependent adverse effects. CRx-102 has been associated with clinical benefit in proof of concept studies in subjects with hand Osteoarthritis (OA) and Rheumatoid Arthritis (RA). In this trial, CRx-102 will be given to subjects with active RA as an add-on therapy to existing stable doses of Disease Modifying Anti-Rheumatic Drugs (DMARDs) including methotrexate (MTX), sulfasalazine, hydroxychloroquine, leflunomide or azathioprine. MTX in combination with other DMARDs (e.g., sulfasalazine or hydroxychloroquine) will be permitted to reflect the current standard of care practices within rheumatology.

NCT ID: NCT00549939 Completed - Clinical trials for Neurogenic Urinary Bladder

Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction

ALFACHIN
Start date: October 2007
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to evaluate the efficacy of Alfuzosin in comparison to Placebo on the detrusor Leak Point Pressure (LPP) in children and adolescents 2-16 years of age with elevated detrusor LPP of neuropathic etiology and detrusor LPP ≥ 40 cm H2O. Secondary objectives were: - To investigate the safety and tolerability of two doses of Alfuzosin in comparison to Placebo in children and adolescents, - To evaluate the effects of the two doses of Alfuzosin in comparison to Placebo on: - Detrusor compliance, - Urinary tract infection, - To investigate the pharmacokinetics of Alfuzosin (population kinetics), - To evaluate the 12-month long-term safety of Alfuzosin 0.1 mg/kg/day and 0.2 mg/kg/day. The study consisted of 2 periods: - a 12-week double blind treatment period where patients were to receive either Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day or placebo then, - a 40-week open label extension treatment period where patients were to receive either Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day.

NCT ID: NCT00549679 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study To Evaluate Safety And Tolerability Of GSK256066 In Chronic Obstructive Pulmonary Disease (COPD) Patients

Start date: October 4, 2007
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and tolerability of the cfor the first time in mild to moderate COPD patients.