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

NCT00300365 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2017-07-28

Study results available
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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).

Conditions

  • Metabolic Syndrome

Interventions

DRUG

Pioglitazone

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

OTHER

Placebo

Pioglitazone placebo

DRUG

Niacin ER

Niacin ER 2.0 g/day

DRUG

Aspirin

asprin 325 mg/day

Sponsors & Collaborators

Principal Investigators

  • Rick Samaha, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00300365 on ClinicalTrials.gov