Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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. 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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00400231
The ClinicalTrials.gov registry entry for NCT00400231 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Study drugs: Metformin and fenofibrate is the first listed.
NCT00400231 reports 0 study locations.
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
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.