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NCT ID: NCT01063855 Completed - Clinical trials for Erectile Dysfunction

Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction

COUPLE
Start date: April 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of dapoxetine compared to placebo in men with premature ejaculation and erectile dysfunction who are currently being treated with a phosphodiesterase-5 inhibitor (ie, sildenafil, vardenafil, or tadalafil) for erectile dysfunction.

NCT ID: NCT01061736 Completed - Clinical trials for Rheumatoid Arthritis

Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients

RA-MOBILITY
Start date: March 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Primary Objectives: Part A (dose ranging study): To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks. Part B (pivotal study): To demonstrate that sarilumab added to MTX was effective in: - reduction of signs and symptoms of rheumatoid arthritis at 24 weeks - inhibition of progression of structural damage at 52 weeks - improvement in physical function at 16 weeks Secondary Objectives: Part B: To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks To assess the safety of sarilumab added to MTX To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.

NCT ID: NCT01061723 Completed - Clinical trials for Ankylosing Spondylitis

Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

ALIGN
Start date: February 2010
Phase: Phase 2
Study type: Interventional

Primary objective: - to evaluate the efficacy of Sarilumab in patients with Ankylosing Spondylitis [AS] using the Assessment in AS working group criteria [ASAS] 20% response criteria [ASAS20] Secondary objectives: - to demonstrate that Sarilumab is effective on: - assessment of higher level of response (ASAS 40% response criteria [ASAS40]) - partial remission - disease activity - range of motion - Magnetic Resonance Imaging [MRI] of the spine - to assess the safety and tolerability of Sarilumab in patients with AS as well as the pharmacokinetic profile of Sarilumab in patients with AS

NCT ID: NCT01060475 Completed - Healthy Clinical Trials

Safety and Tolerability of LIM-0705 in Healthy Male Subjects

LIM
Start date: February 2010
Phase: Phase 1
Study type: Interventional

LIM-0705 dosed separately and in combination with tacrolimus will be safe and well tolerated.

NCT ID: NCT01058980 Completed - Clinical trials for Paroxysmal Atrial Fibrillation

ADenosine Following Pulmonary Vein Isolation to Target Dormant Conduction Elimination: the ADVICE Trial

ADVICE
Start date: December 2009
Phase: Phase 4
Study type: Interventional

Atrial fibrillation (AF) is the most common heart rhythm disorder, impairs quality of life and increases stroke risk and mortality. Despite advances in medical treatment, AF remains uncontrolled in many patients. In many patients, AF is initiated by abnormal electrical impulses from the pulmonary veins. A catheter ablation procedure called pulmonary vein isolation (PVI) has therefore been developed, using heat to isolate the PV foci from the heart. PVI is very effective, but must be repeated in up to 50% of cases because the foci isolation is not permanent after initial PVI. The intravenous administration of a drug called adenosine during the PVI procedure can unmask residual conduction that would otherwise remain unnoticed, so-called "dormant conduction". In our experience, additional ablation guided by adenosine reduces AF recurrence and the need for a repeat PVI procedure. However, the adenosine-guided approach has not yet been proven as standard therapy. The present study, to be conducted at 15 clinical centres in Canada, Europe and Australia is therefore intended to evaluate the efficacy of adenosine-guided ablation to prevent AF recurrence. Five hundred twenty-six patients will be included in the study, which should be completed within 2 years. In all patients, the presence of dormant conduction will be tested with adenosine during PVI. If dormant conduction is observed, additional ablation will be performed in half of these patients selected randomly. If there is no dormant conduction, randomly selected patients will be followed in a registry. If the adenosine-guided approach is demonstrated to improve the success rate of PVI procedures, it should become the standard approach for a "permanent cure" of AF, and therefore benefit patients by reducing arrhythmia recurrence, hospitalizations and the need for repeat interventions.

NCT ID: NCT01058434 Completed - Clinical trials for Relapsed or Refractory Multiple Myeloma

Safety and Efficacy of TKI258 in Relapsed or Refractory Multiple Myeloma Patients, Who Are With or Without t(4;14) Chromosomal Translocation

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

This study will evaluate safety and efficacy of TKI258 in patients with relapsed or refractory multiple myeloma

NCT ID: NCT01058083 Completed - Dyslipidemia Clinical Trials

Safety Study of BMS-770767 in Subjects With Hypercholesterolemia

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

The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)

NCT ID: NCT01057810 Completed - Prostate Cancer Clinical Trials

Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer

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

The purpose of this study is to determine if patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo

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: NCT01056354 Completed - Clinical trials for Influenza and Other Novel Respiratory Viruses

Respiratory Virus Outpatient Study (FLU 002 Plus)

Start date: August 2009
Phase: N/A
Study type: Observational

Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to describe participants seeking medical care in geographically diverse locations with 2009 H1N1 infection and their clinical course over a 14-day period following enrollment. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. This version of the protocol further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded