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NCT00304993 · ClinicalTrials.gov registry record · Phase 4
Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia
A Phase 4 study of Insulin Resistance and Metabolic Syndrome X, sponsored by Foundation Research, Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00304993 is a Phase 4 study of Insulin Resistance and Metabolic Syndrome X that has completed, run by Foundation Research, Florida. The registered enrollment target is 30 participants, below the 245-participant average among 120 other Insulin Resistance trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00304993, a Phase 4 study of Insulin Resistance and Metabolic Syndrome X, has completed, sponsored by Foundation Research, Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Lipid abnormalities in people with the Metabolic Syndrome (the Insulin Resistance Syndrome) are characterized by elevations in triglycerides and LDL cholesterol; low levels of HDL cholesterol; and small, dense LDL particles. Statins generally do not change LDL particle size, so often fenofibrate is added. This combination may still not be sufficient. Niacin is a common third drug added to the treatment regimen, but niacin can increase insulin resistance. This study compares niacin as a third drug to rosiglitazone, an insulin sensitizer.
Conditions Studied
Interventions
- DRUG rosiglitazone
- DRUG fenofibrate
- DRUG niacin
Study Locations (1)
Florida
- Foundation Research - St. Petersburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2001-01 |
| Est. Completion | 2005-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00304993
The ClinicalTrials.gov registry entry for NCT00304993 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 245-participant average among 120 other Insulin Resistance trials with a reported enrollment target (88% lower). The listed sponsor is Foundation Research, Florida, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Insulin Resistance appearing as the primary indexed condition, and to 3 interventions - of which rosiglitazone is the first listed.
NCT00304993 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT00304993 about?
NCT00304993 is a clinical study titled "Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia". Lipid abnormalities in people with the Metabolic Syndrome (the Insulin Resistance Syndrome) are characterized by elevations in triglycerides and LDL cholesterol; low levels of HDL cholesterol; and small, dense LDL particles. Statins generally do not change LDL particle size, so often fenofibrate is ...
What is the current status of trial NCT00304993?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2001-01. Estimated completion is 2005-02.
What conditions does trial NCT00304993 study?
This clinical trial studies the following conditions: Insulin Resistance, Metabolic Syndrome X.
What interventions are being tested in trial NCT00304993?
The interventions under investigation include: rosiglitazone (DRUG), fenofibrate (DRUG), niacin (DRUG).
Who is sponsoring clinical trial NCT00304993?
This trial is sponsored by Foundation Research, Florida, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00304993 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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