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

Completed · Phase 2 · Has a placebo group

Conditions studied: Metabolic Syndrome

In brief

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).

Key facts

Study ID

NCT00300365

Run by

University of Pennsylvania

People needed

38

Starts

2005-11-01

Expected to finish

2010-08-01

Last updated by the study team

2017-07-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women between the ages of 18 and 75
• HDL-C ≤ 40 mg/dL for Men and HDL-C < 50 mg/dl for Women*
• At least two of the following criteria (a, b, c, or d) listed below:
• Abdominal obesity (waist circumference: men 40 inches and women 35 inches)**
• Blood pressure > 130/>85 mmHg in untreated patients OR use of any antihypertensive agent.
• Fasting glucose > 100 mg/dL but < 126 mg/dL
• Fasting triglycerides > 150 mg/dL

You may not qualify if…

• Diabetes or use of anti-hyperglycemic medication in the last 3 months (subjects with a fasting blood glucose of > 110 mg/dL will have an oral glucose tolerance test (OGTT) to rule out diabetes mellitus).
• Subjects on statin therapy may be enrolled, but only if they have been on a stable dose for at least 3 months, and are not expected to require titration of statin therapy during the course of the study.
• Uncontrolled hypertension (defined as systolic bp > 180, diastolic BP > 100).
• Triglycerides > 400 mg/dL
• LDL-cholesterol level > 190 mg/dl
• History of chronic renal insufficiency (serum creatinine >2.0 mg/dl).
• History of liver disease or abnormal liver function tests (LFTs) (>2x upper limit normal)
• Hemoglobin < 10 mg/dL
• History of congestive heart failure (NYHA Class III or IV)
• Women who are pregnant or lactating
• History of a non-skin malignancy within the previous 5 years
• Any major active rheumatologic, pulmonary, or dermatologic disease or other chronic inflammatory condition
• Surgery in the last 90 days
• History of HIV positive
• Active alcohol or drug abuse
• Active peptic ulcer disease
• Gout attack within the past 6 months
• Participation in an investigational drug study within 6 weeks
• Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful study participation
• Subjects on warfarin may be enrolled, but they will be excluded from the optional adipose biopsy.

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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