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NCT00300365 · ClinicalTrials.gov registry record · Phase 2
Pioglitazone vs Placebo in Combination With Niacin Extended Release on Low HDL
A Phase 2 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT00300365: Completed Phase 2 study, sponsored by University of Pennsylvania.
NCT00300365 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00300365, a Phase 2 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study 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).
Primary Outcome
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
Interventions
- OTHER Placebo
- DRUG Aspirin
- DRUG Pioglitazone
- DRUG Niacin ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2005-11 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
What the finished NCT00300365 record still lists
NCT00300365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00300365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00300365 about?
NCT00300365 is a clinical study titled "Pioglitazone vs Placebo in Combination With Niacin Extended Release on Low HDL". 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...
What is the current status of trial NCT00300365?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2005-11. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00300365?
The interventions under investigation include: Placebo (OTHER), Aspirin (DRUG), Pioglitazone (DRUG), Niacin ER (DRUG).
Who is sponsoring clinical trial NCT00300365?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00300365's enrollment target sits among peer trials
38 1467th of 2000 higher than 517 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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