Benefit of Elevation of HDL-C in Women
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|ClinicalTrials.gov Identifier: NCT01921010|
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : April 23, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Outcomes||Drug: Niaspan Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Benefit of Elevation of HDL-cholesterol/Triglyceride Lowering on Cardiovascular Outcomes in Women|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||June 2005|
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.
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.
See Arm Description
- endothelial function [ Time Frame: 16 weeks ]
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): NCT01921010
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||C. Noel Bairey Merz, M.D.||Cedars-Sinai Medical Center|