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NCT ID: NCT00340080 Completed - HIV Infection Clinical Trials

Clinical Utility Of Genetic Screening For HLA-B*5701, On Susceptibility To Abacavir Hypersensitivity

Start date: April 2006
Phase: Phase 4
Study type: Interventional

Study to evaluate the utility of prospective HLA-B*5701 screening on the incidence of abacavir hypersensitivity (ABC HSR) in 1800 previously ABC-naive adults with HIV-1 from Europe, Australia and other countries as applicable. The study has two (co-primary) objectives: i) to determine if screening for HLA-B*5701 prior to ABC-containing HAART results in a lower incidence of clinically-suspected HSR versus current standard of care (no genetic screening) and ii) to determine if screening for HLA-B*5701 prior to ABC-containing HAART, results in a significantly lower incidence of immunologically-confirmed HSR versus current standard of care (no genetic screening or patch testing). The study consists of up to a 28-day screening period, a randomised observation period (Day 1 through Week 6) and, for subjects experiencing a suspected ABC HSR and a subset of ABC-tolerant subjects, an epicutaneous patch test (EPT) assessment period. Eligible subjects will be randomised to one of two study arms: a Current Standard of Care Arm (no prospective genetic screening: Control) and a Genetic Screening Arm (prospective genetic screening). Subjects identified as HLA-B*5701 positive in the prospective Genetic Screening Arm will not receive ABC and will be excluded from further study. Subjects who experience suspected ABC HSR during the 6-week observation will be withdrawn from ABC-containing product and undergo EPT patch testing 6 weeks later.

NCT ID: NCT00338897 Completed - Clinical trials for Venous Thromboembolism

Dose Ranging Study in Elective Total Hip Replacement Surgery

DRIVE
Start date: May 2006
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective is to: - demonstrate the efficacy of SR123781A in the prevention of venous thromboembolism (VTE) by the demonstration of a dose-response in patients undergoing total hip replacement surgery. The secondary objectives are to: - evaluate the safety of SR123781A in the prevention of VTE after elective total hip replacement surgery; and - to assess the SR123781A pharmacokinetic profile in patients undergoing elective total hip replacement surgery.

NCT ID: NCT00338286 Completed - Breast Cancer Clinical Trials

A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy

Start date: March 2, 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the impact on tumor progression as evaluated by progression-free survival (PFS) of epoetin alfa plus standard supportive care as compared with standard supportive care alone (packed red blood cell (RBC) transfusions), for treating anemia according to label guidance in patients with metastatic breast cancer receiving standard chemotherapy.

NCT ID: NCT00337662 Completed - Schizophrenia Clinical Trials

Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia

Start date: May 2006
Phase: Phase 4
Study type: Interventional

The current study has been designed to address the significance of early onset of response prospectively in patients treated with an atypical antipsychotic.

NCT ID: NCT00337558 Completed - Clinical trials for Urinary Incontinence

A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)

SOLAR
Start date: May 2006
Phase: Phase 4
Study type: Interventional

This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment (bladder training) compared to the drug on its own. The study will compare the symptoms of OAB by assessing patient diaries and other patient reported outcomes.

NCT ID: NCT00337103 Completed - Clinical trials for Metastatic Breast Cancer

E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes

Start date: September 20, 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare E7389 versus capecitabine in patients with locally advanced or metastatic breast cancer who are refractory to the most recent chemotherapy. This is an open-label, randomized, two-parallel arm study. Patients will be randomized to receive either E7389 or capecitabine on a one-to-one ratio.

NCT ID: NCT00337090 Completed - Overactive Bladder Clinical Trials

A Study of YM178 in Patients With Symptomatic Overactive Bladder (DRAGON)

Start date: n/a
Phase: Phase 2
Study type: Interventional

The study will examine which dose of YM178 is best in terms of efficacy, safety and tolerability compared to placebo and compared to tolterodine, a marketed product.

NCT ID: NCT00335452 Completed - Angina Unstable Clinical Trials

Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS

CURRENT/OASIS7
Start date: June 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin (two doses) will decrease the risk of ischemic complications (cardiac death (CV death), myocardial infarction (MI), stroke) after a percutaneous coronary intervention (PCI).

NCT ID: NCT00335153 Completed - Clinical trials for Advanced Parkinson's Disease

Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease

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

The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in participants with advanced Parkinson's disease (PD) and severe motor fluctuations.

NCT ID: NCT00334282 Completed - Clinical trials for Carcinoma, Renal Cell

Safety and Efficacy of GW786034 (Pazopanib) In Metastatic Renal Cell Carcinoma

Start date: April 2006
Phase: Phase 3
Study type: Interventional

To evaluate efficacy and safety of pazopanib compared to placebo in patients with locally advanced and/ or metastatic renal cell carcinoma (RCC). Approximately 350-400 eligible patients will be stratified and randomized in a 2:1 ratio to receive either 800 mg pazopanib once daily or matching placebo. The study treatment will continue until patients experience disease progression, unacceptable toxicity or death. Primary objective of the study is to evaluate and compare the two treatment arms for progression-free survival. Principal secondary objective is to evaluate and compare the two treatment arms with respect to overall survival. Other objectives are overall response rate [complete response (CR) + partial response (PR)], rate of CR + PR + 6 months stable disease, and the incidence, severity and causality of adverse events and serious adverse events. Safety and efficacy assessments will be regularly performed on all patients. An Independent Data Monitoring Committee will be established to monitor safety during the course of the study and to evaluate interim efficacy data on overall survival.