A Randomized, Double Blind, Placebo Controlled Trial of Pioglitazone and Niacin Extended Release in Non-Diabetic Patients With Metabolic Syndrome
This is a two-arm, parallel, double-blind randomized prospective clinical trial. The
subjects will be asked to provide informed consent, and then undergo screening for
enrollment criteria at the first visit (-5 weeks). The subjects who are eligible, and
provide informed consent will return for Visit 2 baseline data (-4 weeks), and then begin
the unblinded niacin-ER titration. Specifically, subjects will receive a starting dose of
niacin-ER of 500 mg per day, which will be increased in 500 mg increments every week up to a
dose of 2000 mg per day. Subjects will need to tolerate at least 1500 mg per day of
niacin-ER in order to remain in the study and be randomized. Thus subjects who are unable to
tolerate the 2000 mg daily dose of niacin-ER will be taken back to 1500 mg per day for one
week and then randomized. Subjects who develop prohibitive side effects at doses less than
1500 mg per day will be discontinued from the study. All subjects who are able to take the
target dose of niacin-ER will continue that dose of niacin-ER and come to the GCRC to be
randomized in a 1:1 fashion to either niacin-ER plus pioglitazone or niacin-ER plus matching
placebo for 12 weeks. Pioglitazone will be started at 30 mg and then increased to 45 mg at
week 6. This entry design is designed to minimize the differences in mean dose of niacin-ER
and dropout rate between study groups.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
HDL cholesterol
Rick Samaha, MD
Principal Investigator
University of Pennsylvania
United States: Food and Drug Administration
803751
NCT00300365
November 2005
Name | Location |
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University of Pennsylvania | Philadelphia, Pennsylvania 19104 |