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NCT00400231 · ClinicalTrials.gov registry record · Phase 2
The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study
A Phase 2 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 124
- Enrollment target
NCT00400231: Completed Phase 2 study, sponsored by University of Pennsylvania.
NCT00400231 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 124 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00400231, a Phase 2 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 124 participants
- Enrollment target
Study Summary
Patients with metabolic syndrome, insulin resistance, and elevated triglycerides of 150 mg/dl or higher will be randomized to one of four groups: 1) placebo; 2) metformin; 3) fenofibrate; or 4) combined metformin and fenofibrate for a period of 12 weeks after titration to target dose. We are interested in the effects of these therapies on triglyceride levels, HDL-C, insulin resistance, and markers of inflammation.
Interventions
- DRUG Study drugs: Metformin and fenofibrate
- DRUG Study Drug: Metformin
- DRUG Study Drug: fenofibrate
- DRUG Metformin and Fenofibrate placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2005-08 |
| Est. Completion | 2008-03 |
| Phase | Phase 2 |
What the finished NCT00400231 record still lists
NCT00400231 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Study drugs: Metformin and fenofibrate is the first listed.
NCT00400231 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00400231 about?
NCT00400231 is a clinical study titled "The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study". Patients with metabolic syndrome, insulin resistance, and elevated triglycerides of 150 mg/dl or higher will be randomized to one of four groups: 1) placebo; 2) metformin; 3) fenofibrate; or 4) combined metformin and fenofibrate for a period of 12 weeks after titration to target dose. We are interes...
What is the current status of trial NCT00400231?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2005-08. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00400231?
The interventions under investigation include: Study drugs: Metformin and fenofibrate (DRUG), Study Drug: Metformin (DRUG), Study Drug: fenofibrate (DRUG), Metformin and Fenofibrate placebo (DRUG).
Who is sponsoring clinical trial NCT00400231?
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 NCT00400231's enrollment target sits among peer trials
124 564th of 2000 higher than 1,437 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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