A Phase 3 interventional study of anacetrapib and Comparator: placebo in Coronary Heart Disease (CHD) and CHD Risk-Equivalent Disease, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-11.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
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 of anacetrapib (100 mg) in participants with CHD/CHD risk-equivalent disease on stable dose regimen of statin with or without other lipid-modifying therapy. The two year extension to this study will further evaluate the long-term safety profile and efficacy of anacetrapib in CHD/CHD-risk equivalent patients who are on ongoing therapy with a statin with or without other lipid-modifying therapy.
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 continue in the study until the Extension study is ready to be implemented.
In the optional extension, participants will be assigned to the same treatment arm to which they were assigned in the base study. The total duration of the extension study will be up to 116 weeks; which will include a 2 year treatment period, followed by a 12 week reversal phase. A post-extension study follow-up phone call will be completed 12 weeks after discontinuation or completion of study treatment. Participants previously treated with anacetrapib or placebo will be invited in a 4:1 ratio in an optional extended reversal phase. The total duration of the extended reversal phase will be 1 year.
Participants previously treated with anacetrapib in the DEFINE study will be followed periodically for up to 4 years to determine plasma levels of anacetrapib. Participants will also be invited to participate in a sub-study consisting of one clinic visit to measure anacetrapib levels in the plasma and the subcutaneous adipose tissue.
ACRONYM: DEFINE= Determining the EFficacy and Tolerability of Cholesteryl ester transfer protein (CETP) INhibition with AnacEtrapib
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 1,623 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 132 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Base Study:
Extension Study:
Exclusion Criteria:
Participants randomly assigned to anacetrapib in base study will continue same treatment if enrolled in study extension.
Drug: anacetrapib
Participants randomly assigned to placebo in base study will continue same treatment if enrolled in study extension.
Drug: Comparator: placebo
Participants will receive one tablet of anacetrapib 100 mg once daily for 76 weeks.
Also known as: MK0859
Participants will receive one placebo tablet once daily for 76 weeks.
Change from baseline in Low Density Lipoprotein Cholesterol
Time frame: Baseline and 24 weeks
Number of participants with hepatitis-related adverse experiences
Time frame: Through 88 weeks
Number of participants with Alanine Transaminase consecutive elevations greater than or equal to 3xULN (Upper Limit of Normal)
Time frame: Through 88 weeks
Number of participants with Aspartate Aminotransferase consecutive elevations greater than or equal to 3xULN
Time frame: Through 88 weeks
Number of participants with Creatine Phosphokinase elevations greater than or equal to 10xULN
Time frame: Through 88 weeks
Number of participants with Creatine Phosphokinase elevations greater than or equal 10xULN with muscle symptoms
Time frame: Through 88 weeks
Number of participants with sodium, chloride, or bicarbonate elevations greater than ULN
Time frame: Through 88 weeks
Number of participants with reduction in potassium levels less than LLN (Lower Limit of Normal)
Time frame: Through 88 weeks
Number of participants with myalgia
Time frame: Through 88 weeks
Number of participants with rhabdomyolysis
Time frame: Through 88 weeks
Number of participants with pre-specified adjudicated cardiovascular serious adverse events
Time frame: Through 88 weeks
Number of participants with death from any cause
Time frame: Through 88 weeks
Number of participants with significant increase in Blood Pressure
Time frame: Through 88 weeks
Change from baseline in High Density Lipoprotein Cholesterol
Time frame: Baseline, 24 weeks, and 76 weeks
Change from baseline in non-High Density Lipoprotein Cholesterol
Time frame: Baseline, 24 weeks, and 76 weeks
Change from baseline in Apolipoprotein B
Time frame: Baseline, 24 weeks, and 76 weeks
Change from baseline in Apolipoprotein A-1
Time frame: Baseline, 24 weeks, and 76 weeks
Change from baseline in Low Density Lipoprotein Cholesterol
Time frame: Baseline, 24 weeks, and 76 weeks
No study locations are listed for this record.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC