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Phase 2 Completed N=78 Randomized Quadruple-blind Prevention

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

Source: ClinicalTrials.gov NCT00300365 ↗
Enrolled (actual)
78
Serious AEs
6.4%
Results posted
Jul 2017
Primary outcomePrimary: Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks — 37.4; 36.2; 40.6; 44.2 mg/dL — p=<0.0001

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).

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks
37.4; 36.2; 40.6; 44.2 <0.0001 sig

Eligibility Criteria

Inclusion Criteria

  • Men and women between the ages of 18 and 75
  • HDL-C ≤ 40 mg/dL for Men and HDL-C 130/>85 mmHg in untreated patients OR use of any antihypertensive agent.
  • Fasting glucose > 100 mg/dL but 150 mg/dL

Exclusion Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00300365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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