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NCT ID: NCT01331837 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors

Start date: August 2011
Phase: Phase 4
Study type: Interventional

This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events with tocilizumab in comparison to etanercept in participants with rheumatoid arthritis (RA). Participants will be randomized to receive intravenous (IV) 8 milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 milligrams (mg) etanercept weekly, with or without non-biologic disease-modifying anti-rheumatic drug (DMARD).

NCT ID: NCT01331408 Completed - Clinical trials for Volume Restoration and Shaping of the Buttocks

A Study to Evaluate Efficacy and Safety of Macrolane VRF30 for Volume Restoration and Contouring of the Buttocks

Start date: September 2008
Phase: Phase 4
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of Macrolane for volume restoration and shaping of the buttocks.

NCT ID: NCT01330316 Completed - Hepatitis C Clinical Trials

A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients

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

The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.

NCT ID: NCT01329276 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Assess Particle Deposition and Acute Effects of Symbicort® Forte Turbohaler®) in COPD Patients.

Start date: June 2010
Phase: Phase 4
Study type: Interventional

Computational Fluid Dynamics (CFD) is a new functional imaging method. Since CFD is very sensitive to detect small changes, it might be worthwhile to study the acute effect of formoterol and budesonide combination therapy (Symbicort® forte Turbohaler®) on the upper airway dimensions in severe COPD patients (GOLD III). The increased sensitivity of this technique makes it possible to detect changes in airway caliber in early stages. The regional distribution of resistance and the change in this parameter will provide more insight into the mode of action of the product.

NCT ID: NCT01329029 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS)

REACT
Start date: May 2011
Phase: Phase 4
Study type: Interventional

The objective of the REACT trial is to investigate the effect of roflumilast 500 μg tablets once daily versus placebo on exacerbation rate and pulmonary function in COPD patients who are concomitantly treated with a fixed combination of long-acting β2-agonists (LABA) and inhaled glucocorticosteroids (ICS). In addition, data on safety and tolerability of roflumilast will be obtained. An additional objective is to further characterize the population pharmacokinetic profile of roflumilast and roflumilast N oxide and to further characterize their pharmacokinetics/pharmacodynamics (PK/PD) relationship in terms of efficacy and relevant safety aspects. Patients to be included are required to have severe COPD associated with chronic bronchitis and a history of frequent exacerbations and must be concomitantly treated with a fixed combination of LABA and ICS. Two parallel treatment arms (roflumilast 500 μg once daily and placebo) are included.

NCT ID: NCT01328756 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder (ADHD)

Lisdexamfetamine Dimesylate 2-year Safety Study in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

Start date: July 7, 2011
Phase: Phase 4
Study type: Interventional

While the Lisdexamfetamine Dimesylate (SPD489) clinical program has studied the efficacy, safety, and tolerability of SPD489 in treating core symptoms of ADHD in children and adolescents aged 6-17 years and adults aged 18-55 years, the majority of these studies have been of short duration - up to 8 weeks. A number of long-term studies have been undertaken (up to 1 year) and these have confirmed the safety and ongoing efficacy in this patient population. In order to run a study with investigational medication within Poland the study changed to a Phase 3 rather than a Phase 4 study in that country. Please note that the study number remains as SPD489-404. Study SPD489-404 has been designed to further evaluate the long-term effects of SPD489 in children and adolescents over a 2-year treatment period.

NCT ID: NCT01328041 Completed - Clinical trials for Infection, Human Immunodeficiency Virus

A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.

VIKING-3
Start date: May 2011
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to assess the antiviral activity and safety of a dolutegravir (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults with current or historical failure on an integrase inhibitor (INI) containing regimen. The study will assess DTG 50mg twice daily administered initially with the current failing ART regimen but then with an optimised background ART regimen (OBR) after Day 7. The first analyses will be conducted after the last subject enrolled has completed 24 weeks. Subjects may remain on study after Week 24.

NCT ID: NCT01327885 Completed - Soft Tissue Sarcoma Clinical Trials

Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma

Start date: March 10, 2011
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have disease progression within 6 months prior to study enrolment following standard therapies which must have included an anthracycline, unless contraindicated and then at least one additional regimen after failure of the anthracycline.

NCT ID: NCT01327846 Completed - Atherosclerosis Clinical Trials

Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)

CANTOS
Start date: April 11, 2011
Phase: Phase 3
Study type: Interventional

Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated hsCRP could prevent recurrent cardiovascular events. The purpose of the extension phase of the main study is to collect additional long-term safety data on continued exposure to canakinumab in patients who participated in the pivotal phase. Sub-study 1 (CACZ885M2301S1): The purpose of this sub-study was to evaluate the effect of quarterly subcutaneous canakinumab treatment for 24 months comparted with placebo on the carotid plaque burden measured by integrated vascular MRI in patients enrolled in the CACZ885M2301 study (CANTOS). Sub-study 2 (CACZ885M2301S2): The purpose of this CANTOS sub-study was to determine whether, in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared to placebo, on top of standard of care could increase insulin secretion and insulin sensitivity.

NCT ID: NCT01327053 Completed - Clinical trials for Basal Cell Carcinoma

A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

BOLT
Start date: June 29, 2011
Phase: Phase 2
Study type: Interventional

This study assessed the efficacy and safety of oral treatment with two dose levels of LDE225 in patients with locally advanced or metastatic BCC.