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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: NCT00550420 Terminated - Alzheimer's Disease Clinical Trials

Study Of Rosiglitazone XR In Subjects With Mild-to-Moderate Alzheimers

Start date: October 1, 2007
Phase: Phase 3
Study type: Interventional

This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed AVA105640. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study followed by 8mg RSG XR. Subject participation will last until one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this study is to evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD who have completed AVA105640. The secondary objective of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele status

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.

NCT ID: NCT00545532 Completed - Influenza, Human Clinical Trials

A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.

Start date: February 4, 2008
Phase: Phase 3
Study type: Interventional

This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be randomized to receive either conventional dose (30 milligrams [mg] to 75 mg twice daily orally [po], depending on age and weight) or double dose (60 mg-150 mg twice daily po depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.

NCT ID: NCT00541658 Completed - Clinical trials for Postmenopausal Osteoporosis

A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis

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

The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

NCT ID: NCT00532558 Terminated - Clinical trials for Hypercholesterolemia

Efficacy of Lapaquistat Acetate on Blood Cholesterol Levels in Treating Subjects With Hypercholesterolemia

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

The purpose of the study is to determine the reduction of LDL-cholesterol level after treatment with 50 mg per day of lapaquistat acetate once daily (QD).

NCT ID: NCT00532298 Completed - Influenza Clinical Trials

Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over

Start date: September 20, 2007
Phase: Phase 2
Study type: Interventional

This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.