Status:
COMPLETED
Benefit of Elevation of HDL-C in Women
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Cardiovascular Outcomes
Eligibility:
FEMALE
18-100 years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01921010
Start Date
June 1 2003
End Date
June 1 2005
Last Update
April 23 2019
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048