Benefit of Elevation of HDL-C in Women

April 22, 2019 updated by: Noel Bairey Merz, Cedars-Sinai Medical Center

Benefit of Elevation of HDL-cholesterol/Triglyceride Lowering on Cardiovascular Outcomes in Women

The combination of HDL-C elevation, lowering of triglycerides and further LDL-C reduction accomplished by the addition of niacin to statin medication would improve endothelial function as compared to LDL-C reduction alone in patients with and without coronary artery disease and the combination of low HDL-C/high triglycerides.

The combination of lipid lowering therapy would have beneficial effects on markers of inflammation. These benefits would be particularly evident in women.

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
        • Cedars-Sinai Medical Center

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Stable CAD(coronary artery disease) patients on statin therapy with LDL-C between 90-135mg/dl and triglycerides > 150mg/dl
  • Well-controlled diabetes with HbA1C < 7.5 currently on statin therapy, able to tolerate Niacin without unstable blood glucose levels with LDL-C between 90-135mg/dl and triglycerides > 150mg/dl
  • Stable patients on statin therapy with LDL-C between 90-135mg/dl and triglycerides > 150mg/dl

Exclusion Criteria:

  • History of MI(myocardial infarction), PTCA(percutaneous transluminal coronary angiography) 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(liver function test) >1.5x's ULN( upper limit of normal) at screening
  • Diabetes with Hg A1C(hemoglobin A1c) < 7.5
  • 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Niaspan
Patients will be randomized to Niaspan 1.5 g/d in addition to usual care statin lipid lowering agents. The dose of Niaspan will be titrated over a 4-week period and then patients will remain on study drug for additional 12 weeks. The dose of statin will be adjusted in a blinded fashion in both groups at week 10 to similarly achieve a LDL-C of less than 100mg/dl.
Drug: Niaspan
See Arm Description
Placebo Comparator: Control
patients will be randomized to placebo 1.5 g/d in addition to usual care statin lipid lowering agents. The dose of placebo will be titrated over a 4-week period and then patients will remain on study drug for additional 12 weeks. The dose of statin will be adjusted in a blinded fashion in both groups at week 10 to similarly achieve a LDL-C of less than 100mg/dl.
Drug: Placebo
See Arm Description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
endothelial function
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

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

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: C. Noel Bairey Merz, M.D., Cedars-Sinai Medical Center

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, 2003

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

August 9, 2013

First Submitted That Met QC Criteria

August 12, 2013

First Posted (Estimate)

August 13, 2013

Study Record Updates

Last Update Posted (Actual)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 22, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3954

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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