Heterozygous Familial Hypercholesterolemia (HeFH) Clinical Trial
Official title:
A 12-Week, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Assess the Efficacy and Safety of MK-0859 When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Therapies in Japanese Patients With Heterozygous Familial Hypercholesterolemia
This study will evaluate the effects of anacetrapib (MK-0859) on low-density lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with heterozygous familial hypercholesterolemia when added to an existing statin lipid-modifying therapy.
| Status | Completed |
| Enrollment | 68 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - If female, cannot be of reproductive potential - Diagnosed with heterozygous familial hypercholesterolemia - Have been treated with an appropriate and stable dose of statin± other lipid-lowering medication(s) for at least 6 weeks Exclusion Criteria: - Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor - Homozygous familial hypercholesterolemia - Severe chronic heart failure - Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery by-pass graft (CABG), unstable angina, or stroke within 3 months |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme Corp. |
Arai H, Teramoto T, Daida H, Ikewaki K, Maeda Y, Nakagomi M, Shirakawa M, Kakikawa T, Numaguchi H, Johnson-Levonas AO, Vaidya S, Blaustein RO. Efficacy and Safety of the Cholesteryl Ester Transfer Protein Inhibitor Anacetrapib in Japanese Patients with He
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change from Baseline in LDL-C (beta-quantification [BQ] method) | Baseline and Week 12 | No | |
| Primary | Percentage of Participants who Experience at Least One Adverse Event (AE) | 12 weeks | Yes | |
| Secondary | Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C) | Baseline and Week 12 | No | |
| Secondary | Percent Change from Baseline in Non-HDL-C | Baseline and Week 12 | No | |
| Secondary | Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I) | Baseline and Week 12 | No | |
| Secondary | Percent Change from Baseline in Apolipoprotein B (Apo-B) | Baseline and Week 12 | No | |
| Secondary | Percent Change from Baseline in Lipoprotein(a) (Lp[a]) | Baseline and Week 12 | No |