Status:
COMPLETED
Study to Assess the Tolerability and Efficacy of Anacetrapib in Patients With Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease (MK-0859-019)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Coronary Heart Disease (CHD)
CHD Risk-Equivalent Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy of anacetrapib (100 mg) for 24 weeks relative to placebo, on plasma concentrations of Low Density Lipoprotein Cholesterol and assess the safety and tolerability o...
Detailed Description
The 76 week treatment period is followed by a 12 week reversibility phase which can be extended by up to another 12 weeks in order to allow participants who have completed their week 88 visit to conti...
Eligibility Criteria
Inclusion
- Base Study:
- Patient has Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease and is treated with a statin, with well controlled LDL-C
- Extension Study:
- Patient has completed the base study including the reversibility period (i.e. 12 or to up to 24 weeks).
- Patient is on statin therapy ± lipid-modifying therapy since the end of the base study and planning to continue taking a statin throughout the study
Exclusion
- History of heart failure, arrhythmias, heart attack, unstable angina, or stroke within 3 months prior to screening, uncontrolled blood pressure, uncontrolled high cholesterol or liver disease.
- History of mental instability, drug/alcohol abuse within the past 5 years
- Pregnant or breast-feeding
- History of cancer within the last 5 years
- HIV positive
- Donated blood products within 8 weeks
- Currently participating or have participated in a study with an investigational compound within the last 30 days
Key Trial Info
Start Date :
March 24 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2017
Estimated Enrollment :
1623 Patients enrolled
Trial Details
Trial ID
NCT00685776
Start Date
March 24 2008
End Date
November 23 2017
Last Update
December 11 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.