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NCT ID: NCT00076999 Completed - HIV Infections Clinical Trials

Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children

Start date: November 2003
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide information concerning the pharmacokinetic characteristics of tipranavir and ritonavir in this age group, and to determine the relative bioavailability of the TPV liquid formulation and TPV capsule formulation in adolescents switching from liquid to capsule. The secondary objective of this study is the determination of the dose of topranavir and ritonavir (TPV/r) in children and adolescents between 2 and 18 years of age required for an adult equivalent systemic exposure of TPV/r 500 mg / 200 mg.

NCT ID: NCT00076388 Completed - Clinical trials for Non-Small-Cell Lung Carcinoma

Iressa Versus Docetaxel (Taxotere)

Start date: February 2004
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effects of ZD1839 or docetaxel in patients with advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy.

NCT ID: NCT00075270 Completed - Neoplasms, Breast Clinical Trials

Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

Start date: January 2004
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.

NCT ID: NCT00074581 Completed - HIV Infections Clinical Trials

Preventing Sexual Transmission of HIV With Anti-HIV Drugs

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

This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.

NCT ID: NCT00073528 Completed - Breast Neoplasms Clinical Trials

Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer

Start date: December 9, 2003
Phase: Phase 3
Study type: Interventional

This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or metastatic breast cancer, who had not received prior therapy for advanced or metastatic disease.

NCT ID: NCT00073307 Completed - Clinical trials for Carcinoma, Renal Cell

Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer

Start date: November 2003
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.

NCT ID: NCT00072293 Completed - Breast Cancer Clinical Trials

Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases

23-01
Start date: December 2001
Phase: N/A
Study type: Interventional

RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection. PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases.

NCT ID: NCT00071331 Completed - Clinical trials for Congestive Heart Failure

EVEREST: Efficacy of Vasopressin Antagonism in hEart failuRE: Outcome Study With Tolvaptan

Start date: September 2003
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults with worsening congestive heart failure (CHF).

NCT ID: NCT00071279 Completed - Pulmonary Embolism Clinical Trials

SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis

Start date: November 2003
Phase: Phase 3
Study type: Interventional

Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. Research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur. In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo. Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.

NCT ID: NCT00069784 Completed - Clinical trials for Diabetes Mellitus, Non-Insulin-Dependent

The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)

ORIGIN
Start date: August 2003
Phase: Phase 3
Study type: Interventional

The primary objectives of the ORIGIN study were: - To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes; - To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes. The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce: - total mortality (all causes); - the risk of diabetic microvascular outcomes; - the rate of progression of IGT or IFG to type 2 diabetes.