SDAC: Research Portfolio
REPRISE (2014-present) A Phase 3b, multicenter, randomized-withdrawal, placebo-controlled. double-blind, parallel-group trial to compare the efficacy and safety of tolvaptan (45 to 120 mg/day, split-dose) in subjects with chronic kidney disease between late stage 2 to early stage 4 due to autosomal dominant polycystic kidney disease. Primary outcome measures are treatment difference in the change of eGFR from pre-treatment baseline to post-treatment follow-up, normalized (divided) by each subject's treatment duration. Industry sponsored.
Pyoderma Gangrenosum (2014-present) A phase 3 program of two randomized, double-blind, placebo-controlled studies of efficacy and saftey of gevokizumab in treating active ulcers of pyoderma gangrenosum. The primary endpoint is complete closure of the target ulcer at 18 weeks. Industry sponsored.
AMG162 (2014-present). This is a phase 3, prospective, multicenter, single-arm study in children 2 to 17 years of age with osteogenesis imperfecta (OI) to evaluate efficacy and safety of denosumab. Primary Outcome Measures are change from baseline in lumbar spine BMD Z-score, as assessed by DXA, and change in lumbar spine BMD Z-score, as assessed by DXA. Industry sponsored.
B148 Program (2013-present). Phase 3 program of multiple randomized, double-blind, placebo-controlled, parallel group studies to assess the efficacy, safety, and tolerability of bococizumab in subjects with primary hyperlipidemia, mixed dyslipidemia, and heterozygous familial hypercholesterolemia at risk of cardiovascular events. Primary outcomes include percent change from baseline in fasting LDL-C and rates of major cardiovascular events. Industry sponsored.
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.
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.
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.
Clinical Trials Program Manager
poulsen [at] biostat.wisc.edu