Benefit of Elevation of HDL-C in Women
Completed · Phase 4 · Has a placebo group
Conditions studied: Cardiovascular Outcomes
In brief
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.
Key facts
- Study ID
- NCT01921010
- Run by
- Cedars-Sinai Medical Center
- People needed
- 43
- Starts
- 2003-06-01
- Expected to finish
- 2005-06-01
- Last updated by the study team
- 2019-04-23
Who can join
Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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