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

This study has been completed.
Sponsor:
Collaborator:
Kos Pharmaceuticals
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00300365
First received: March 6, 2006
Last updated: June 29, 2017
Last verified: June 2017
  Purpose
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).

Condition Intervention Phase
Metabolic Syndrome Drug: Pioglitazone Other: Placebo Drug: Niacin ER Drug: Aspirin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Pioglitazone and placebo were overencapsulated
Primary Purpose: Prevention
Official Title: A Randomized, Double Blind, Placebo Controlled Trial of Pioglitazone and Niacin Extended Release in Non-diabetic Patients With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks [ Time Frame: Baseline, after 12 weeks of pioglitazone vs placebo ]
    Mean increase in HDL-C from baseline (week -4) to 12 weeks post randomization in non-diabetic subjects with low HDL-C and metabolic syndrome. After baseline, all subjects titrated niacin extended release (ER) to 2 grams (g) daily over 4 weeks. Subjects were also given 325 mg aspirin to take 30 minutes before the niacin ER. After 4 weeks, half of the subjects added blinded pioglitazone 30mg/day (milligrams/day) for 6 weeks followed by 45 mg/day for 6 weeks; the other half added placebo. HDL-C was was assessed at baseline and 12 weeks post randomization


Enrollment: 38
Study Start Date: November 2005
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Pioglitazone + Open-Label Niacin
Intervention: Pioglitazone, initially 30mg, then titrated to 45mg + niacin ER 2.0 g/day + aspirin 325 mg/day
Drug: Pioglitazone
Pioglitazone, initially 30 mg, then titrated to 45 mg/day
Other Name: Actos
Drug: Niacin ER
Niacin ER 2.0 g/day
Drug: Aspirin
asprin 325 mg/day
Placebo Comparator: Placebo +Open-Label Niacin
Intervention: Pioglitazone Placebo + 2.0 g/day Open-Label Niacin + 325 mg/day Aspirin
Other: Placebo
Pioglitazone placebo
Drug: Niacin ER
Niacin ER 2.0 g/day
Drug: Aspirin
asprin 325 mg/day

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 visit (-5 weeks). The subjects who are eligible, and provide informed consent will return for Visit 2 baseline data (-4 weeks), and then begin the unblinded niacin-ER titration. Specifically, subjects will receive a starting dose of niacin-ER of 500 mg per day, which will be increased in 500 mg increments every week up to a dose of 2000 mg per day. Subjects will need to tolerate at least 1500 mg per day of niacin-ER in order to remain in the study and be randomized. Thus subjects who are unable to tolerate the 2000 mg daily dose of niacin-ER will be taken back to 1500 mg per day for one week and then randomized. Subjects who develop prohibitive side effects at doses less than 1500 mg per day will be discontinued from the study. All subjects who are able to take the target dose of niacin-ER will continue that dose of niacin-ER and come to the General Clinical Research Center (GCRC) to be randomized in a 1:1 fashion to either niacin-ER plus pioglitazone or niacin-ER plus matching placebo for 12 weeks. Pioglitazone will be started at 30 mg and then increased to 45 mg at week 6. This entry design is designed to minimize the differences in mean dose of niacin-ER and dropout rate between study groups.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women between the ages of 18 and 75
  2. HDL-C ≤ 40 mg/dL for Men and HDL-C < 50 mg/dl for Women*
  3. At least two of the following criteria (a, b, c, or d) listed below:

    1. Abdominal obesity (waist circumference: men 40 inches and women 35 inches)**
    2. Blood pressure > 130/>85 mmHg in untreated patients OR use of any antihypertensive agent.
    3. Fasting glucose > 100 mg/dL but < 126 mg/dL
    4. Fasting triglycerides > 150 mg/dL

Exclusion Criteria:

  1. 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).
  2. 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.
  3. Uncontrolled hypertension (defined as systolic bp > 180, diastolic BP > 100).
  4. Triglycerides > 400 mg/dL
  5. LDL-cholesterol level > 190 mg/dl
  6. History of chronic renal insufficiency (serum creatinine >2.0 mg/dl).
  7. History of liver disease or abnormal liver function tests (LFTs) (>2x upper limit normal)
  8. Hemoglobin < 10 mg/dL
  9. History of congestive heart failure (NYHA Class III or IV)
  10. Women who are pregnant or lactating
  11. History of a non-skin malignancy within the previous 5 years
  12. Any major active rheumatologic, pulmonary, or dermatologic disease or other chronic inflammatory condition
  13. Surgery in the last 90 days
  14. History of HIV positive
  15. Active alcohol or drug abuse
  16. Active peptic ulcer disease
  17. Gout attack within the past 6 months
  18. Participation in an investigational drug study within 6 weeks
  19. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful study participation
  20. Subjects on warfarin may be enrolled, but they will be excluded from the optional adipose biopsy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300365

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Kos Pharmaceuticals
Investigators
Principal Investigator: Rick Samaha, MD University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00300365     History of Changes
Other Study ID Numbers: 803751
Pionir ( Other Identifier: University of Pennsylvania )
Study First Received: March 6, 2006
Results First Received: April 4, 2017
Last Updated: June 29, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Pennsylvania:
HDL cholesterol
Metabolic syndrome

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Aspirin
Pioglitazone
Niacin
Niacinamide
Nicotinic Acids
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Hypoglycemic Agents
Hypolipidemic Agents

ClinicalTrials.gov processed this record on August 23, 2017