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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00590629
First Posted: January 10, 2008
Last Update Posted: September 14, 2011
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.
Collaborators:
General Clinical Research Center (GCRC)
Kos Pharmaceuticals
Information provided by:
Cedars-Sinai Medical Center
  Purpose

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 Intervention Phase
Coronary Artery Disease Drug: Niaspan Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Enrollment: 43
Study Start Date: June 2002
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Niaspan
    1500 mg Niaspan for 16 weeks
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590629


Locations
United States, California
CSMC
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
General Clinical Research Center (GCRC)
Kos Pharmaceuticals
  More Information

Responsible Party: Donna Polk, CSMC
ClinicalTrials.gov Identifier: NCT00590629     History of Changes
Obsolete Identifiers: NCT00192010
Other Study ID Numbers: HDL3954
GCRC: Grant #MO1-RR00425
First Submitted: December 26, 2007
First Posted: January 10, 2008
Last Update Posted: September 14, 2011
Last Verified: December 2007

Keywords provided by Cedars-Sinai Medical Center:
Women with and without CAD

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Niacin
Nicotinic Acids
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs