CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Pioglitazone +3 moredrug
Likely dose
Pioglitazone 45 mg/day orally; Niacin ER 2.0 g/day orally; Aspirin 325 mg/day orallyAI-extracted
Key inclusion· 3
  • ✓Age 18–75 years
  • ✓HDL-C ≤40 mg/dL (men) or <50 mg/dL (women)
  • ✓At least two of the following: abdominal obesity (waist ≥40 in men, ≥35 in women), BP >130/>85 mmHg (untreated or on antihypertensives), fasting glucose 100–<126 mg/dL, or triglycerides >150 mg/dL
Key exclusion· 10
  • ✕Diabetes or anti-hyperglycemic medication use in the last 3 months
  • ✕Uncontrolled hypertension (SBP >180 or DBP >100 mmHg)
  • ✕Triglycerides >400 mg/dL
  • ✕LDL-cholesterol >190 mg/dL

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00300365
NCT00300365Phase 2Completed
CompareCT.gov

A Randomized, Double Blind, Placebo Controlled Trial of Pioglitazone and Niacin Extended Release in Non-diabetic Patients With Metabolic Syndrome

University of Pennsylvania·interventional·Posted Mar 8, 2006·Updated Jul 28, 2017

In Brief

A Phase 2 clinical trial evaluating Pioglitazone, Placebo, and 2 other interventions for Metabolic Syndrome. Completed, enrolled 38 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetabolic Syndrome
CountriesUnited States
CollaboratorsKos Pharmaceuticals

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 8, 2006
Enrollment StartNov 1, 2005
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 20.3 years ago

Interventions

Pioglitazonedrug

Pioglitazone, initially 30 mg, then titrated to 45 mg/day

Placeboother

Pioglitazone placebo

Niacin ERdrug

Niacin ER 2.0 g/day

Aspirindrug

asprin 325 mg/day