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NCT ID: NCT00574613 Completed - Skin Fibrosis Clinical Trials

Efficacy and Safety Study of p144 to Treat Skin Fibrosis in Systemic Sclerosis

Start date: September 2007
Phase: Phase 2
Study type: Interventional

Transforming growth factor-beta 1 (TGF-β1) is consistently over expressed in most fibrotic diseases and displays a variety of profibrotic effects in fibroblasts. Activation of TGF-β receptors induces the activation of several kinase signalling cascades leading to the phosphorylation of SMAD proteins as well as to the activation of SMAD-independent kinases that collectively activate ECM synthesis and fibroblast growth and differentiation into myofibroblasts. TGF-β1 is one of the main mediators in the fibrotic process, associated to both scarring and a long list of pathologies related to chronic inflammation and which affect all type of organs and tissues. An increase in TGF-β1 mRNA and protein levels has been described in these processes. Peptide 144 (P144) is the acetic salt of a 14mer peptide from human TGF-β1 type III receptor (betaglycan). P144 TGF-β1-inhibitor has been specifically designed to block the interaction between TGF-β1 and TGF-β1 type III receptor, thus blocking its biological effects. P144 has shown significant antifibrotic activity in mice receiving repeated subcutaneous injections of bleomycin, a widely accepted animal model of human scleroderma, and could contribute to the development. The purpose of this study is to asses the efficacy and safety of topical application of P144 in the treatment of skin fibrosis in patients with systemic sclerosis.

NCT ID: NCT00571649 Completed - Clinical trials for Venous Thromboembolism

Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients

MAGELLAN
Start date: December 2007
Phase: Phase 3
Study type: Interventional

This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.

NCT ID: NCT00571584 Completed - Clinical trials for Congenital Bleeding Disorder

High Dose of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors

Start date: November 2002
Phase: Phase 4
Study type: Interventional

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.

NCT ID: NCT00568334 Completed - Varicella Clinical Trials

Study of Two Formulations of GSK Biologicals' Varicella Vaccine

Start date: November 1, 2007
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate a modified formulation of GSK Biologicals' live attenuated varicella vaccine. In vivo pre-clinical data show this change has no negative impact on vaccine safety. This present study is undertaken to rule out any negative impact on the immunogenicity and safety of GSK Biologicals' live attenuated varicella virus vaccine.

NCT ID: NCT00567996 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control

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

This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

NCT ID: NCT00567346 Completed - Clinical trials for Allergic Rhinoconjunctivitis

Efficacy and Safety of Grass Pollen Sublingual Immunotherapy

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

The study is assessing efficacy and safety of three different dosage regimens of grass pollen sublingual immunotherapy in adult patients suffering from grass pollen related rhinoconjunctivitis.

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: NCT00565812 Completed - Osteoarthritis Clinical Trials

A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee

ITIC
Start date: November 2007
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of this 2-year study is to evaluate the safety, tolerability and disease modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS), in overweight and obese subjects with knee osteoarthritis. The efficacy of SD-6010 will be evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment of the study knee as the primary endpoint.

NCT ID: NCT00565409 Completed - Clinical trials for Arthritis, Rheumatoid

Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

PRESERVE
Start date: March 2008
Phase: Phase 4
Study type: Interventional

To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.