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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.

NCT ID: NCT00333775 Completed - Breast Cancer Clinical Trials

A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer

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

This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals.

NCT ID: NCT00332020 Completed - Clinical trials for Venous Thromboembolism

Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

RECORD 2
Start date: February 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and can help prevent blood clots forming after a hip replacement operation.

NCT ID: NCT00329628 Completed - Clinical trials for Venous Thromboembolism

Rivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin

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

The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and prevent blood clot which may form after total hip replacement operation.

NCT ID: NCT00326976 Completed - Clinical trials for Myocardial Infarction

Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury

Start date: August 2006
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate whether FX06 is capable of limiting infarct size following balloon catheterization for acute myocardial infarction.

NCT ID: NCT00321737 Completed - Esophagitis, Reflux Clinical Trials

Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis

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

The purpose of this study is to assess the ability of once-daily (QD) treatment with dexlansoprazole modified release (MR) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE).

NCT ID: NCT00314184 Completed - Bipolar Disorder Clinical Trials

Quetiapine Fumarate Bipolar Maintenance Monotherapy

SPaRCLe
Start date: March 2005
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

NCT ID: NCT00310804 Completed - Influenza Clinical Trials

Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)

Start date: September 2005
Phase: Phase 3
Study type: Interventional

The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-derived control vaccine licensed in Europe.

NCT ID: NCT00309699 Completed - Bipolar Disorder Clinical Trials

A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder

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

The purpose of this study is to evaluate the effectiveness and safety of flexible-doses paliperidone ER (3 to 12 mg as needed) compared with placebo over 3 weeks in patients with Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate the effects of paliperidone ER on global functioning, and will compare the effectiveness of flexible doses of paliperidone ER to that of quetiapine over 12 weeks.

NCT ID: NCT00303589 Completed - Clinical trials for Soft Tissue Infections

A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections

Start date: December 2005
Phase: Phase 2
Study type: Interventional

This 3 arm study will compare the efficacy and safety of beta-lactam with that of 'standard care' in patients with complicated skin and skin structure infections requiring hospitalization. Patients will be randomized to receive 1)beta-lactam 750mg iv q8h 2)beta-lactam 1500mg iv q8h or 3)'standard care' [PRP (nafcillin or flucloxacillin) or vancomycin, plus aztreonam or ciprofloxacin]. The anticipated time on study treatment is <3 months and the target sample size is 100-500 individuals.