drugset
drugset / Trial / NCT00300365

Pioglitazone vs Placebo in Combination With Niacin Extended Release on Low HDL

NCT00300365 ↗

Phase 2 Completed 38 enrolled University of Pennsylvania Kos Pharmaceuticals · collab
RandomizedParallel-groupQuadruple-blindPrevention

Summary

We will test our primary hypothesis that combining niacin extended release (niacin-ER), at a daily dosage of up to 2.0 g with pioglitazone, at a daily dosage of 45 mg will result in a 12% greater increase in HDL-C when compared to niacin-ER monotherapy over 12 weeks in non-diabetic patients with the metabolic syndrome (see Table 1).

Timeline

Start
2005-11
Primary completion
2010-08
Completion
2010-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Pioglitazone Small molecule 45 mg —
Background Aspirin Small molecule 325 mg —
Background Niacin ER Unknown 1.5 g —
Background Niacin ER Unknown 2 g —

Indications

metabolic syndrome X