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NCT ID: NCT01064791 Completed - Clinical trials for Renal Transplantation

Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients

Start date: December 2009
Phase: Phase 2
Study type: Interventional

This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo renal transplantation.

NCT ID: NCT01064492 Completed - Healthy Volunteers Clinical Trials

A Phase 1 Study To Estimate The Relative Bioavailability And Food Effect Of PF-04620110 In Healthy Adult Subjects

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

PF 04620110 is an acylCoA:diacylglycerol acyltransferase 1 (DGAT1) inhibitor that is being developed for the treatment of type 2 diabetes mellitus (T2DM). It is anticipated that PF 04620110 will have anti diabetic effects through inhibition of intestinal triglyceride absorption and potentially weight loss. The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of multiple oral formulations of PF 04620110 administered to healthy volunteers.

NCT ID: NCT01064414 Completed - Clinical trials for Diabetes Mellitus, Type 2

An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

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

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who have reduced kidney function.

NCT ID: NCT01064258 Completed - Clinical trials for Obstructive Sleep Apnea

Trial of Auto Continuous Positive Airway Pressure (CPAP)

Start date: August 2009
Phase: Phase 1
Study type: Interventional

Background: In patients with obstructive sleep apnea, automatic continuous positive airway pressure machines (autoCPAP) are said to be capable of identifying various breathing abnormalities during sleep and to correct them by increasing progressively the positive pressure applied to the airway. Once breathing becomes normal, pressure slowly declines. AutoCPAP devices have never been tested in Phase I studies. The investigators hypothesised that normal breathing would not be recognised as such, and that pressure would increase even in a normal subject.

NCT ID: NCT01063946 Completed - Clinical trials for Neoplasms, Malignant

A Study to Investigate the Disposition of Radio-labeled AVE8062 Compound Administered as a 30-minute IV Infusion to Patients With Advanced Solid Tumor

Start date: January 2010
Phase: Phase 1
Study type: Interventional

Primary Objectives: - To determine the excretion balance and systemic exposure of radioactivity after intravenous infusion of [14C]-AVE8062 to humans - To determine the pharmacokinetics of AVE8062 and RPR258063 and their contribution to overall exposure - To collect samples to determine the metabolic pathways of AVE8062 and identify the chemical structures of the main metabolites Secondary Objective: - To assess the safety profile of the drug

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: NCT01063231 Completed - Colonic Diseases Clinical Trials

Evaluation of PillCamâ„¢ Colon 2 in Visualization of the Colon

Start date: September 2009
Phase: Phase 3
Study type: Interventional

Evaluate accuracy of PCCE-2 in detecting patients with colonic polyps as compared to conventional colonoscopy.

NCT ID: NCT01063088 Completed - Influenza Clinical Trials

Adult Safety Study of 2009/2010 Seasonal Influenza Vaccine

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

The purpose of the study is to verify the safety and immunogenicity of a trivalent seasonal influenza vaccine with strain composition according to World Health Organization (WHO)/European Union (EU) recommendation for the 2009/2010 season.

NCT ID: NCT01062607 Completed - Bipolar Disorders Clinical Trials

Study of the Clinical Management of Bipolar Disease

WAVE bd
Start date: April 2010
Phase: N/A
Study type: Observational

This study is to provide reliable information on the management of bipolar disorders in real every day, clinical practice, to determine the clinical outcomes of such management and use of resources in relation to the disease, and to establish the factors associated with different management patterns and clinical outcomes.

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.