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NCT ID: NCT00428948 Completed - Clinical trials for Polycystic Kidney Disease, Autosomal Dominant

Tolvaptan Phase 3 Efficacy and Safety Study in ADPKD

TEMPO3/4
Start date: January 2007
Phase: Phase 3
Study type: Interventional

This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.

NCT ID: NCT00428844 Completed - Osteomyelitis Clinical Trials

Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci

Start date: June 26, 2007
Phase: Phase 2
Study type: Interventional

This is a research study designed to look at the efficacy and safety of daptomycin given at a dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections caused by Staphylococci. These types of bacteria are among the most common types of bacteria causing infections of prosthetic joints.

NCT ID: NCT00428610 Completed - Ovarian Cancer Clinical Trials

A Study of Chemotherapy Treatment for Patients With Ovarian Cancer

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

The primary objective is to determine whether LY573636-sodium (hereafter referred to as LY573636) is effective in treating platinum-resistant ovarian cancer. Patients will receive an intravenous infusion of study drug once every 28 days. Computed tomography (CT) scans and CA-125 tests will be done before the first dose and then after every other treatment.

NCT ID: NCT00428090 Completed - Alzheimer's Disease Clinical Trials

Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease

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

Rosiglitazone (RSG) has been tested and is approved as a treatment for type II diabetes mellitus, a disease that occurs when the body ineffectively uses glucose. RSG XR, the investigational drug, is an extended-release form of RSG. This study tests whether RSG XR safely provides benefit to people with mild to moderate Alzheimer's disease (AD). RSG XR is a new approach to AD therapy and this study tests whether one's genes alter the effectiveness of RSG XR. Glucose is used by cells to make energy that they need to live. Changes in the ability of cells to use of glucose can lead to diseases like diabetes. Glucose levels may be lower in the brains of AD patients, and their brain cells may also use glucose less well than in unaffected people. The proper function of brain cells may be critical to memory and thought. If brain cells use glucose poorly, this might impact AD. Drugs that help brain cells properly use glucose may help a person maintain normal memory and thinking. Data suggesting that RSG may help AD patients was first seen in a small study at the Univ. of Washington and then from a larger international GSK study. In the first study, those receiving RSG once daily for 6 months scored better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that benefited most from therapy with RSG XR had a specific genetic pattern. They lacked the gene that caused them to produce apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene from one parent. Subjects with one copy of the APOE e4 gene remained fairly stable while those with two copies of APOE e4 continued to worsen during the 6-month treatment. This study will directly test the effect of RSG XR on people who either have or lack the APOE e4 gene.

NCT ID: NCT00426972 Completed - Trauma Clinical Trials

Trial of Zesteem (Estradiol) in Healing of Split Thickness Skin Graft Donor Sites

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

This trial will assess the effects of Zesteem (estradiol) on the healing of split thickness skin graft donor sites in patients aged 18-85 years.

NCT ID: NCT00424476 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

BLISS-52
Start date: May 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.

NCT ID: NCT00424255 Completed - Clinical trials for Neoplasms, Head and Neck

Study Of Adjuvant Lapatinib In High-Risk Head And Neck Cancer Subjects After Surgery

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

This is a randomised, double-blind, placebo-controlled, multicentre, global Phase III trial comparing the efficacy of adjuvant oral lapatinib versus placebo in high-risk subjects with head and neck cancer following surgery. Lapatinib or placebo will be administered post-operatively in combination with chemoradiotherapy followed by maintenance with lapatinib or placebo for 1 year. The primary goal is to determine if lapatinib is effective at reducing the recurrence of the disease in these high-risk patients.

NCT ID: NCT00424190 Completed - Clinical trials for Bacterial Infections

Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

cSSSI
Start date: February 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

NCT ID: NCT00424177 Completed - Clinical trials for Purpura, Thrombocytopaenic, Idiopathic

Repeated Exposure to Eltrombopag in Adults With Idiopathic Thrombocytopenic Purpura (REPEAT)

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

This open-label, repeat dosing study, TRA108057, will evaluate the efficacy, safety and tolerability of eltrombopag, when administered in a repeat, cyclic dosing schedule. The study will describe the effect of repeated (3 cycles), intermittent dosing of eltrombopag on the pharmacodynamics and durability of eltrombopag response as measured by the peripheral platelet counts. For more information or to see if you qualify, please visit: http://www.itpstudy.com/gov

NCT ID: NCT00423657 Completed - Clinical trials for Bacterial Infections

Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

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

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.