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Benefit of Elevation of HDL-C on Cardiovascular Outcomes in Women

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00590629
Collaborator
General Clinical Research Center (GCRC) (Other), Kos Pharmaceuticals (Industry)
43
Enrollment
1
Location
41
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Prevention
Study Start Date :
Jun 1, 2002
Actual Primary Completion Date :
Nov 1, 2005
Actual Study Completion Date :
Nov 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Stable women on statin therapy with LDL-C between 90-135mg/dl and triglycerides > 150mg/dl
    Exclusion Criteria:

    • History of MI, PTCA or surgery within previous 3 months

    • Currently on Niaspan and unwilling to withdraw Niaspan therapy or known intolerance to niacin

    • Active or known gall bladder disease

    • Pregnant or nursing women

    • Significant comorbidity that precludes participation

    • Significant liver disease, active alcoholism, or LFT >1.5x's ULN at screening

    • Diabetes or glucose > 126 mg/dl at screening

    • PI perceived inability to comply with protocol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CSMC Los Angeles California United States 90048

    Sponsors and Collaborators

    • Cedars-Sinai Medical Center
    • General Clinical Research Center (GCRC)
    • Kos Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00590629
    Other Study ID Numbers:
    • HDL3954
    • GCRC: Grant #MO1-RR00425
    • NCT00192010
    First Posted:
    Jan 10, 2008
    Last Update Posted:
    Sep 14, 2011
    Last Verified:
    Dec 1, 2007
    Keywords provided by , ,
    Women with and without CAD
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Niacin
    Nicotinic Acids

    Study Results

    No Results Posted as of Sep 14, 2011