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NCT00590629 · ClinicalTrials.gov registry record · Phase 4
Benefit of Elevation of HDL-C on Cardiovascular Outcomes in Women
A Phase 4 study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 43
- Enrollment target
NCT00590629 is a Phase 4 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 43 participants.
The verdict
NCT00590629, a Phase 4 study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 43 participants
- Enrollment target
Study Summary
Several risk factors including high cholesterol contribute to heart disease. We know that lowering triglycerides and raising HDL (protective cholesterol) in men reduces the risk for heart disease. We expect that women will share this same benefit because the combination of high triglycerides and low HDL appears to be a more important risk for heart disease in women. Niacin reduces triglycerides and raises HDL. We also expect to see improvement in markers of inflammation and clot formation and blood vessel health, which we hypothesize should all confer a reduced risk of heart disease in women. Women already taking lipid lowering statin will receive niacin therapy. We will measure blood lipid levels, markers of inflammation and clotting as well as a non-invasive measure of blood vessel reactivity. After 3 months of therapy we will repeat these measures.
Interventions
- DRUG Niaspan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2002-06 |
| Est. Completion | 2005-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00590629
The ClinicalTrials.gov registry entry for NCT00590629 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Niaspan is the first listed.
NCT00590629 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00590629 about?
NCT00590629 is a clinical study titled "Benefit of Elevation of HDL-C on Cardiovascular Outcomes in Women". Several risk factors including high cholesterol contribute to heart disease. We know that lowering triglycerides and raising HDL (protective cholesterol) in men reduces the risk for heart disease. We expect that women will share this same benefit because the combination of high triglycerides and low...
What is the current status of trial NCT00590629?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 43 participants. The study started on 2002-06. Estimated completion is 2005-11.
What interventions are being tested in trial NCT00590629?
The interventions under investigation include: Niaspan (DRUG).
Who is sponsoring clinical trial NCT00590629?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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