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

This study has been completed.

First Received: December 26, 2007 Last Updated: January 9, 2008 History of Changes

Sponsors and Collaborators:	Cedars-Sinai Medical Center GCRC: General Clinical Research Center, Grant #MO1-RR00425 Kos Pharmaceuticals
Information provided by:	Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT00590629

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 IV

MedlinePlus related topics: Coronary Artery Disease Heart Disease in Women Heart Diseases

Drug Information available for: Niacin Niacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment

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:

1500 mg Niaspan for 16 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590629

Locations

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

Sponsors and Collaborators

Cedars-Sinai Medical Center

GCRC: General Clinical Research Center, Grant #MO1-RR00425

Kos Pharmaceuticals

More Information

No publications provided

Responsible Party:	CSMC ( Donna Polk )
Study ID Numbers:	HDL3954, GCRC: Grant #MO1-RR00425
Study First Received:	December 26, 2007
Last Updated:	January 9, 2008
ClinicalTrials.gov Identifier:	NCT00590629 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:

Women with and without CAD

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Nicotinic Acids
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Niacin
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009