Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Stati… (NCT01524289) | Clinical Trial Compass
CompletedPhase 3
Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020)
306 participantsStarted 2012-02-03
Plain-language summary
The objective of this study is to evaluate the efficacy and tolerability of adding anacetrapib to ongoing statin therapy in participants with heterozygous familial hypercholesterolemia (HeFH).
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* If of reproductive potential, must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control for the duration of the study
* Diagnosed with Heterozygous Familial Hypercholesterolemia (HeFH)
* Have been treated with an optimal dose of statin for at least 6 weeks
Exclusion Criteria:
* Received treatment with low-density lipoprotein (LDL) apheresis within 4 weeks of screening or expect to undergo treatment with LDL apheresis during the course of the study
* Homozygous familial hypercholesterolemia
* Severe chronic heart failure
* Uncontrolled hypertension
* Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), unstable angina, or stroke within 3 months
* Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
* Active or chronic hepatobiliary, hepatic, or gall bladder disease
* Pregnant or breast-feeding, or plans to become pregnant during the study or within 2 years after stopping study medication
* History of ileal bypass, gastric bypass, or other significant condition associated with malabsorption
* Human immunodeficiency virus (HIV) positive
* History of malignancy ≤5 years
* Donated blood products or has had phlebotomy of \>300 mL within 8 weeks or intends to donate 250 mL of blood products or receive blood products within the projected duration of the study
* Currently taking medications…
What they're measuring
1
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) - Treatment Phase
Timeframe: Baseline and Week 52
2
Percentage of Participants With Any Adverse Event - Treatment Phase
Timeframe: Up to 52 weeks
3
Percentage of Participants With Any Treatment-Related Adverse Event - Treatment Phase
Timeframe: Up to 52 weeks
4
Percentage of Participants With Any Serious Adverse Event - Treatment Phase
Timeframe: Up to 52 weeks
5
Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event - Treatment Phase
Timeframe: Up to 52 weeks
6
Percentage of Participants With Changes in Systolic Blood Pressure (SBP) >= 10 mm Hg
Timeframe: Up to 52 weeks
7
Percentage of Participants With Changes in SBP >= 15 mm Hg
Timeframe: Up to 52 weeks
8
Percentage of Participants With Changes in Diastolic Blood Pressure (DBP) >= 10 mm Hg