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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00590629
Recruitment Status : Completed
First Posted : January 10, 2008
Last Update Posted : September 14, 2011
General Clinical Research Center (GCRC)
Kos Pharmaceuticals
Information provided by:
Cedars-Sinai Medical Center

December 26, 2007
January 10, 2008
September 14, 2011
June 2002
November 2005   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00590629 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Benefit of Elevation of HDL-C on Cardiovascular Outcomes in Women
Not Provided

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.

Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Coronary Artery Disease
Drug: Niaspan
1500 mg Niaspan for 16 weeks
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2005
November 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
GCRC: Grant #MO1-RR00425
Not Provided
Not Provided
Donna Polk, CSMC
Cedars-Sinai Medical Center
  • General Clinical Research Center (GCRC)
  • Kos Pharmaceuticals
Not Provided
Cedars-Sinai Medical Center
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP