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

September 13, 2011 updated by: Cedars-Sinai Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • CSMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Collaborators

Kos Pharmaceuticals
General Clinical Research Center (GCRC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

January 9, 2008

First Posted (Estimate)

January 10, 2008

Study Record Updates

Last Update Posted (Estimate)

September 14, 2011

Last Update Submitted That Met QC Criteria

September 13, 2011

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDL3954
  • GCRC: Grant #MO1-RR00425

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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