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NCT ID: NCT01436656 Completed - Clinical trials for Melanoma and Metastatic Colorectal Cancer

A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma

Start date: September 5, 2011
Phase: Phase 1
Study type: Interventional

CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or metastatic melanoma harboring the BRAF V600 mutation (during dose escalation phase and expansion phase) and patients with metastatic colorectal cancer harboring the BRAF V600 mutation (during the expansion phase) will be enrolled. The study consists of a dose escalation part were cohorts of patients will receive escalating oral doses of LGX818, followed by a safety dose expansion part were patients will be treated with oral dose of LGX818 given at the MTD or RP2D.

NCT ID: NCT01435993 Terminated - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis

Start date: September 8, 2011
Phase: Phase 1
Study type: Interventional

This study will investigate an experimental new drug, GSK1223249 in patients diagnosed with relapsing forms of multiple sclerosis. The study will specifically investigate safety (vital signs like heart rate, blood pressure, Magnetic Resonance Imaging (MRI), and other markers of health from blood samples), tolerability (any side effects that occur, if any), and pharmacokinetics (how the body processes the drug and how long the drug stays in the blood, and in cerebro-spinal fluid). The study will also investigate if patients' own immune system interacts with GSK1223249.

NCT ID: NCT01434160 Completed - Contraception Clinical Trials

LCS12 Adolescent Study

Start date: September 2011
Phase: Phase 3
Study type: Interventional

The study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped intrauterine contraceptive system in female adolescents under 18 years of age. Approximately 300 generally healthy, post-menarcheal female adolescents with regular menses at the beginning of the study requiring contraception will be enrolled into the study. Duration of study treatment is approximately 12 months with an option to continue the use of the contraceptive system up to three years if the woman is willing to continue the use after the first 12 months. The incidence of adverse events over 12 month treatment period will be the main outcome of this study. Also the efficacy (number of pregnancies), discontinuation rate and pharmacokinetics will be evaluated.

NCT ID: NCT01434134 Completed - Breast Cancer Clinical Trials

Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy

PRADA
Start date: September 2011
Phase: Phase 2
Study type: Interventional

Women treated for breast cancer are at increased risk for cardiovascular disease, including heart failure. In this study, by using magnetic resonance imaging (MRI), the investigators want to assess if heart failure medications such as beta blockers and angiotensin receptor blockers can prevent cardiac dysfunction during early breast cancer therapy.

NCT ID: NCT01431287 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Tiotropium +Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)

Start date: September 2011
Phase: Phase 3
Study type: Interventional

The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with COPD.

NCT ID: NCT01430494 Completed - Clinical trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease

OVERTURE
Start date: June 2011
Phase: N/A
Study type: Observational

To collect characteristics of patients with ADPKD across a broad population, over time to better understand disease progression (signs, symptoms and outcomes). Association with total kidney volume changes and other measures of disease progression will be determined in order to identify a population at increased risk for disease progression. The economic and quality life impact of ADPKD will be assessed. Subjects who terminated participation early from clinical trials with tolvaptan may also be followed.

NCT ID: NCT01429051 Completed - Cancer Clinical Trials

A Clinical Trial With Intranasal Fentanyl in Cancer Patients With Breakthrough Pain

NOSE-400
Start date: August 2011
Phase: Phase 3
Study type: Interventional

The aim of this clinical trial was to demonstrate the efficacy of a 400 μg dose strength of intranasal fentanyl spray (INFS, Instanyl®) and to evaluate the safety and to establish long term tolerability of treatment with INFS doses of 50, 100, 200 and 400 μg.

NCT ID: NCT01428453 Completed - Alzheimer's Disease Clinical Trials

A Phase 2a Study to Evaluate the Effect of Rilapladib (SB-659032) in Alzheimer's Disease

Start date: October 1, 2011
Phase: Phase 2
Study type: Interventional

The study is designed to investigate the effects of rilapladib on biomarkers related to the Alzheimer's disease, and cognitive function.

NCT ID: NCT01424267 Terminated - Clinical trials for Abdominal Aortic Aneurysm

Zenith® LP Abdominal Aortic Aneurysm (AAA) Post-Market Registry

Start date: July 2010
Phase: N/A
Study type: Observational

A registry to collect additional prospective intra-operative and follow-up information on physician use of the CE-marked Zenith® Low Profile Abdominal Aortic Aneurysm (AAA) Endovascular Graft under routine clinical care.

NCT ID: NCT01422317 Completed - Clinical trials for Myocardial Infarction

Effects of High-dose n-3 Fatty Acids on Clinical Outcome and Serum Lipids - Omacor Following Acute Myocardial Infarction

OFAMI
Start date: September 1995
Phase: Phase 3
Study type: Interventional

The object of this study was to evaluate the effect of a high-dose ethylester concentrate of of n-3 fatty acids administered early after an acute myocardial infarction on subsequent cardiac events and serum lipids.The second purpose of this study was to assess the impact of high-dose n-3 fatty acids on several markers of coagulation, inflammation, endothelial dysfunction and lipid peroxidation. Re-investigation was intended after a prolonged wash-out-period.