Status:
TERMINATED
Comparative Study of the Effect of Ezetimibe Versus Extended-Release Niacin on Atherosclerosis
Lead Sponsor:
Walter Reed Army Medical Center
Collaborating Sponsors:
Abbott
Conditions:
Atherosclerosis
Eligibility:
All Genders
30+ years
Phase:
PHASE4
Brief Summary
Recent evidence on the use of statin therapy indicates the potential for ultra-low levels of low-density lipoprotein (LDL-C) to provide greater protection from recurrent coronary heart disease (CHD) e...
Eligibility Criteria
Inclusion
- Male and female subjects, ≥ 30 years old with either known atherosclerotic coronary or vascular disease OR coronary risk equivalents defined as either:
- diabetes mellitus,
- multiple coronary risk factors with a Framingham Risk Score \> 2% per year, or
- an elevated coronary calcium score (\> 400 for men, \> 200 for women)
- Currently being treated with a statin (Simvastatin 20 mg/d or its equivalent) as monotherapy for treatment of hyperlipidemia
- Recent lipids (within the past 3 months without interval change in the statin regimen) showing both: LDL-C \< 100 mg/dL and HDL-C \< 50 mg/dL (men) or \< 55 mg/dL (women)
Exclusion
- Current use of or known intolerance to niacin or ezetimibe
- Known history of liver disease (cirrhosis, chronic hepatitis) or abnormal liver associated enzymes, \> 3x the upper laboratory reference value
- Enrollment in another drug or device research protocol
- Females who are pregnant, expect to get pregnant during the course of the study, or are breastfeeding
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00397657
Start Date
November 1 2006
End Date
October 1 2009
Last Update
June 17 2009
Active Locations (2)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307
2
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912