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Biostatistics and Medical Informatics
Clinical Trials Program Statistical Data Analysis Center
Research Portfolio - Selected Ongoing Trials

COSMIC-HF Trial (2013 - present) A phase 2 double-blind, randomized, placebo-controlled, multicenter, dose escalation study to select and evaluate an oral modified release formulation of omecamtiv mecarbil in subjects with HF and left ventricular systolic dysfunction. The primary objectives of this study are (i) to select an oral modified release (MR) formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in subjects with HF and left ventricular systolic dysfunction and (ii) to characterize its pharmacokinetics (PK) after 12 weeks of treatment. Industry sponsored.

 

AMG785 (2012 - present) Two phase 3 multicenter, randomized, double-blind, clinical trials to determine the efficacy and safety of AMG785 in the treatment of postmenopausal women with osteoporosis. Primary outcome measures include clinical and vertebral fracture. Industry sponsored.

 

ATOMIC-AHF Trial (2011 - present) A phase 2 double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of IV infusion treatment with omecamtiv mecarbil in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure. The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure. Industry sponsored.

 

LMS 002 (2011 - present) A phase 3 multicenter, double-blind, placebo-controlled randomized discontinuation study followed by an open-label extension period to evaluate the efficacy and safety of amifampridine phosphate (3,4-diaminopyridine phosphate) in patients with Lambert-Eaton Myasthenic Syndrome (LEMS). Primary outcome measures: change from baseline Quantitative Myasthenia Gravis (QMG) at 14 days. Industry sponsored.

 

DVS SR (2010 - present) A phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety and tolerability of desvenlafaxine succinate sustained-release (DVS SR) in the treatment of children and adolescent outpatients with major depressive disorder. Primary outcome measures: change from baseline to final on-therapy visit in the Children's Depression Rating Scale-Revised (CDRS-R) Total score. Industry sponsored.

 

PEGASUS-TIMI (2010 - present) A phase 3 randomized, double-blind, placebo controlled, parallel group, multinational trial, to assess the prevention of thrombotic events with ticagrelor compared to placebo on a background of acetyl salicylic acid (ASA) therapy in patients with history of myocardial infarction. Primary outcome measures: any event after randomization from the composite of cardiovascular death, non-fatal MI, or non-fatal stroke. Industry sponsored.

 

JAK Oral Psoriasis (2010-present) The phase 3 clinical development program for psoriasis will include multiple independent trials of CP-690,550. The primary outcome is improving signs and symptoms and physical function. Industry sponsored.

 

JAK RA (2009-present) The phase 3 clinical development for rheumatoid arthritis will include multiple independent trials of CP-690,550. The primary outcome is improving signs and symptoms and physical function. Industry sponsored.

 

LPL100601 and SB-480848/033 (2008-present) The phase 3 clinical development program is expected to include two independent trials. The program will be conducted worldwide. The first trial is expected to enroll 15,500 participants with chronic coronary heart disease and will compare the incidence of major adverse cardiovascular events. Participants who qualify for the study will be randomized to either darapladib or placebo administered in addition to standard therapy. The second trial will test whether darapladib can safely lower the chances of having a cardiovascular event when treatment is started within 30 days after an acute coronary syndrome (ACS).

 

Lurasidone HCl (2008-present) Select trials in a phase 3 clinical development will include multiple independent trials of SM-13496. One trial is randomized, placebo-and-active comparator controlled, clinical trial to study the safety and efficacy of two doses of lurasidone HCI in acutely psychotic patients with schizophrenia. The primary outcome measure is change in total PANSS score from baseline to the end of the double blind treatment period.

 

TEMPO 3/4 (2007-present) A phase 3, multi-center, double-blind, placebo-controlled, parallel-arm trial to determine long-term safety and efficacy of oral tolvaptan tablets regimens in adult subjects with autosomal dominant polycystic kidney disease.

Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Grantham JJ, Higashihara E, Perrone RD, Krasa HB, Ouyang J, Czerwiec FS, for the TEMPO Investigators. Tolvaptan in patients with autosomal dominant polycystic kidney disease. The New England Journal of Medicine November 3, 2012: pp1-12.

 

 
Last Modified: and is in reverse chronological order by end date.
 
Selected Ongoing Trials | Completed Trials, Ongoing Publications
 
UW Madison, Burton James Lab UW Madison, Commencement UW Madison, Chemical vials UW Madison, Bascom Hall UW Madison, Chapman Lab
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