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NCT ID: NCT01068665 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes

BEGIN™
Start date: March 2010
Phase: Phase 3
Study type: Interventional

This trial is conducted in South Africa, Europe and North America. The aim of this trial is to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or dipeptyl peptidase 4 (DPP-4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs) qualifying for intensified treatment.

NCT ID: NCT01066962 Completed - HIV Infections Clinical Trials

Study of Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir in HIV-infected Antiretroviral naïve Subjects

ANRS 143
Start date: August 2010
Phase: Phase 3
Study type: Interventional

The triple therapy darunavir/r + tenofovir/emtricitabine is likely to become a relevant first-line treatment option in the years to come. The dual combination of boosted darunavir + raltegravir is an innovative treatment option that combines two potent new antiretroviral drugs, one of which belongs to a new drug class (integrase inhibitor). The expected efficacy profile of this combination is promising. Moreover, this combination might have a better tolerance profile and has the advantage of sparing the NRTI class. In the context of tenofovir/emtricitabine currently being a reference backbone in first-line antiretroviral regimens, we hypothesise that, in combination with darunavir/r, raltegravir may be an alternative option if its efficacy is non-inferior to tenofovir/emtricitabine.

NCT ID: NCT01066793 Completed - Clinical trials for Hepatitis C, Chronic

PROPHESYS 2: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b

Start date: October 2007
Phase: N/A
Study type: Observational

This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <2000.

NCT ID: NCT01064401 Completed - Clinical trials for Relapsing-Remitting Multiple Sclerosis

Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis

(DECIDE)
Start date: May 2010
Phase: Phase 3
Study type: Interventional

The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in participants with relapsing remitting multiple sclerosis. The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population.

NCT ID: NCT01058174 Completed - Clinical trials for Liver Transplantation

Liver Transplant European Study Into the Prevention of Fungal Infection

TENPIN
Start date: December 15, 2009
Phase: Phase 3
Study type: Interventional

Prevention of invasive fungal infection in high risk patients following liver transplant.

NCT ID: NCT01057537 Completed - Clinical trials for Cardiovascular Diseases

UMPIRE - Use of a Multidrug Pill In Reducing Cardiovascular Events

UMPIRE
Start date: June 2010
Phase: Phase 3
Study type: Interventional

People with established cardiovascular disease need secondary prevention that addresses multiple risk factors. Complexity & cost confer particularly difficult barriers to uptake of treatment; recovery from a stroke or heart attack typically necessitates multiple drugs for cholesterol, blood pressure and platelet function. A low-cost, fixed-dose, once-daily combination polypill, the Red Heart Pill, has been formulated by Dr Reddy's Laboratories. UMPIRE will evaluate whether provision of this polypill compared with usual medications improves adherence and clinical outcomes among high-risk patients in Europe and India. The results will be used to develop recommendations for equitable access.

NCT ID: NCT01056120 Completed - Clinical trials for De Novo and Re-stenosed Coronary Artery Lesions

Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice

ENERGY
Start date: March 2010
Phase: N/A
Study type: Observational

To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.

NCT ID: NCT01054339 Completed - Clinical trials for Alpha-1 Antitrypsin Deficiency

Safety & Efficacy Study of rAAV1-CB-hAAT for Alpha-1 Antitrypsin Deficiency

Start date: June 2010
Phase: Phase 2
Study type: Interventional

Assessment of the safety and efficacy of intramuscular (IM) administration of a recombinant adenoassociated virus (rAAV) alpha-1 antitrypsin (AAT) vector (rAAV1-CB-hAAT) in AAT-deficient adults at three dosage levels [6.0 × 10e11, 1.9 × 10e12 and 6.0 × 10e12 vector genome particles (vg) per kg body weight]. Funding Sources - The FDA Office of Orphan Products Development and NIH National Heart, Lung, and Blood Institute

NCT ID: NCT01045603 Completed - Clinical trials for Breakthrough Cancer Pain

Instanyl® Non-Interventional Study

INIS
Start date: December 2009
Phase: N/A
Study type: Observational

The aim of this study is to describe the use of Instanyl® (Intranasal fentanyl spray) in the treatment of breakthrough pain (BTP) in cancer patients by success of dose titration and distribution of dose strength. Data will be collected at three different time points over a 3 month period.

NCT ID: NCT01042769 Completed - Clinical trials for Diabetes Mellitus Type 2

A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus

Start date: February 2010
Phase: Phase 3
Study type: Interventional

This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.