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NCT ID: NCT01519661 Completed - Clinical trials for Pulmonary Infections

Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis

Start date: January 2012
Phase: Phase 4
Study type: Interventional

This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.

NCT ID: NCT01518803 Completed - Obesity Clinical Trials

A Mediterranean-style Breakfast and Postprandial Lipid Disorders in Obese Pre-adolescents and Adults

Start date: May 2010
Phase: N/A
Study type: Interventional

Obesity has a major impact on the development of cardiovascular disease and other related conditions and it is of particular concern in children. The prevalence of childhood overweight and obesity in Spain is among the highest in the European continent. Childhood obesity has been associated with diseases that were thought to apply only to adults, such as the metabolic syndrome. Insulin resistance is the most important risk factor in subjects with severe obesity, which together with visceral obesity, exacerbates postprandial triglyceridemia, increasing cardiovascular risk. In this context, the investigators hypothesize that the postprandial lipid metabolism is also impaired in obese pre-adolescents, as it is in obese adults. This includes not only exacerbated postprandial triglyceridemia, but also impaired levels of inflammation markers. In addition, the investigators hypothesize that the lipid and protein composition of postprandial chylomicrons and chylomicron remnants are also altered in obese children when compared with their normal-weight counterparts, and that these postprandial lipoproteins induce foam cell formation differently. The investigators also believe that a Mediterranean-style meal can help to normalize the altered postprandial lipid metabolism in obese adolescents.

NCT ID: NCT01518283 Completed - Clinical trials for Hormone Refractory Prostate Cancer

Study of Weekly Cabazitaxel for Advanced Prostate Cancer

Start date: May 2012
Phase: Phase 2
Study type: Interventional

This is a multicenter open label non randomized phase II clinical trial of Weekly Cabazitaxel for Advanced Prostate Cancer in Hormone-Refractory Patients Previously Treated with Docetaxel. The purpose of this study is to evaluate the activity of the weekly administration of cabazitaxel as time to progression by PSA at week 12.

NCT ID: NCT01517802 Completed - Clinical trials for Metastatic Breast Cancer

A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate

Start date: March 28, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to collect follow-up safety data from participants in completed abiraterone acetate studies for a maximum duration of 9 years.

NCT ID: NCT01517698 Completed - Fragile X Syndrome Clinical Trials

A Study of RO4917523 in Patients With Fragile X Syndrome

Start date: May 2012
Phase: Phase 2
Study type: Interventional

This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4917523 in adolescent and adult patients with fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12 weeks.

NCT ID: NCT01517412 Completed - Clinical trials for Type 2 Diabetes Mellitus

Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

Start date: February 2012
Phase: Phase 3
Study type: Interventional

Primary Objective: - To compare the two treatment regimens in terms of change of HbA1c from baseline to endpoint (week 24) Secondary Objective: - To assess the effect of the 2 lixisenatide regimens on: - The percentage of patients who reached the target of HbA1c < 7% or ≤ 6.5% at week 24 - Fasting Plasma Glucose (FPG) - 7-point Self-Monitored Plasma Glucose (SMPG) profiles - Body weight - To assess the safety and tolerability of the 2 lixisenatide regimens

NCT ID: NCT01516736 Completed - Breast Cancer Clinical Trials

Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim

PROTECT2
Start date: March 2012
Phase: Phase 3
Study type: Interventional

The study will assess the efficacy of LA-EP2006 compared to Peg-Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

NCT ID: NCT01516541 Completed - Clinical trials for Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)

A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease

Start date: January 2012
Phase: Phase 3
Study type: Interventional

This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated risk for cardiovascular disease. Eligible patients will be randomized to receive either dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary, guidelines-based medical care. Anticipated time on study treatment is 4 years.

NCT ID: NCT01516528 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care

ACCESS
Start date: November 17, 2011
Phase: N/A
Study type: Observational

This is a prospective, observational, non-drug interventional, non-randomized study to compare the rate of moderate-severe COPD exacerbations in patients of all Chronic Obstructive Pulmonary Disease (COPD) severities with and without cardiovascular diseases. A total study population of 3330 subjects will be recruited by general practitioners (GPs) and assessed over a 27 month time frame.

NCT ID: NCT01515423 Completed - Schizophrenia Clinical Trials

Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia

Start date: May 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.