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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00300365
Recruitment Status : Completed
First Posted : March 8, 2006
Results First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Kos Pharmaceuticals
Information provided by (Responsible Party):
University of Pennsylvania

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 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 or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Pioglitazone Other: Placebo Drug: Niacin ER Drug: Aspirin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
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
Study Start Date : November 2005
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00300365

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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Kos Pharmaceuticals
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Principal Investigator: Rick Samaha, MD University of Pennsylvania
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Responsible Party: University of Pennsylvania Identifier: NCT00300365    
Other Study ID Numbers: 803751
Pionir ( Other Identifier: University of Pennsylvania )
First Posted: March 8, 2006    Key Record Dates
Results First Posted: July 28, 2017
Last Update Posted: July 28, 2017
Last Verified: June 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:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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
Hypoglycemic Agents
Hypolipidemic Agents
Lipid Regulating Agents