Status:
COMPLETED
Pioglitazone vs Placebo in Combination With Niacin Extended Release on Low HDL
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Kos Pharmaceuticals
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 incr...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00300365
Start Date
November 1 2005
End Date
August 1 2010
Last Update
July 28 2017
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104