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NCT ID: NCT00576303 Completed - Anemia Clinical Trials

A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.

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

This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00575588 Completed - Type 2 Diabetes Clinical Trials

52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period

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

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sulphonylurea in addition with metformin.

NCT ID: NCT00574873 Completed - Clinical trials for Chronic Myeloid Leukemia

Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML

Start date: February 5, 2008
Phase: Phase 3
Study type: Interventional

Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year.

NCT ID: NCT00571675 Completed - Clinical trials for Hormone Refractory Prostate Cancer

A Study Comparing AT-101 in Combination With Docetaxel and Prednisone Versus Docetaxel and Prednisone in Men With Chemotherapy-Naïve Metastatic Hormone Refractory Prostate Cancer (HRPC)

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

This is a randomized, double-blind, placebo-controlled, multinational Phase 2 study to evaluate and compare oral AT-101 in combination with docetaxel and prednisone versus docetaxel and prednisone plus placebo in the treatment of chemotherapy-naïve metastatic hormone-refractory prostate cancer, who have received hormonal therapy but not chemotherapy.

NCT ID: NCT00571649 Completed - Clinical trials for Venous Thromboembolism

Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients

MAGELLAN
Start date: December 2007
Phase: Phase 3
Study type: Interventional

This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.

NCT ID: NCT00567996 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control

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

This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

NCT ID: NCT00567489 Completed - Diabetes Clinical Trials

IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients

Impendia
Start date: January 2008
Phase: Phase 4
Study type: Interventional

Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) and Automated Peritoneal Dialysis (APD)patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels. Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be assessed.

NCT ID: NCT00567190 Completed - Clinical trials for Metastatic Breast Cancer

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer

CLEOPATRA
Start date: February 12, 2008
Phase: Phase 3
Study type: Interventional

This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Participants could have received one prior hormonal treatment for MBC. Participants may have received systemic breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the participant had experienced a disease-free interval (DFI) of greater than or equal to (≥)12 months from completion of adjuvant systemic treatment (excluding hormonal therapy) to metastatic diagnosis. Participants may have received trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment. Participants were randomized in 1:1 ratio to receive either pertuzumab or placebo, along with trastuzumab and docetaxel once every 3 weeks (q3w), during the treatment phase of the study until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Participants in the Placebo arm were not allowed to receive open-label pertuzumab after discontinuation from study treatment. However, if any analysis of overall survival had met the predefined criteria for statistical significance, participants in the Placebo arm still on treatment were offered the option to receive open-label pertuzumab in addition to other study medications.

NCT ID: NCT00566657 Completed - Clinical trials for Peripheral Vascular Diseases

Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions

TAMARIS
Start date: November 2007
Phase: Phase 3
Study type: Interventional

Primary objective is to demonstrate the superiority of riferminogene pecaplasmid over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin lesions. Secondary objectives are to evaluate: - The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major amputation; - The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death; - The safety of riferminogene pecaplasmid in the study population.

NCT ID: NCT00565812 Completed - Osteoarthritis Clinical Trials

A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee

ITIC
Start date: November 2007
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of this 2-year study is to evaluate the safety, tolerability and disease modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS), in overweight and obese subjects with knee osteoarthritis. The efficacy of SD-6010 will be evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment of the study knee as the primary endpoint.