Benefit of Elevation of HDL-C in Women

Cardiovascular Outcomes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921010
• Other study ID #: 3954
• Status: Completed
• Phase: Phase 4
• Start date: June 2003
• Est. completion date: June 2005

Study information

• Verified date: April 2019
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Outcomes

Intervention

Drug:
• Niaspan
See Arm Description
• Placebo
See Arm Description

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelial function		16 weeks