SDAC: Research Portfolio
REG475 (2015-present) A randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy and safety of REGN475 in patients with pain due to osteoarthritis of the knee or hip. Primary outcome measure is the change from baseline to week 16 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale score. Industry sponsored.
HARMONY (2015-present) A long-term, randomized, double-blind, placebo-controlled, study to determine the effect of albiglutide, when added to standard blood glucose lowering therapies, on major cardiovascular event s in patients with Type 2 Diabetes Mellitus. Primary outcome measures are time to first occurrence of major adverse cardiovascular events (MACE; cardiovascular death, myocardial infarction, or stroke). Industry sponsored.
NAVIGATE (2015-present) Multicenter, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority phase III study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent Embolic Stroke of Undetermined Source (ESUS), comparing rivaroxaban 15 mg once daily with aspirin 100 mg. Primary Outcome Measures: Time from randomization to first occurrence of any of the components of the composite outcome (adjudicated), including: Stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging), Systemic embolism: and time from randomization to the first occurrence of major bleeding. Industry sponsored.
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.
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.
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.
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.
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.
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