A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Dyslipidemia (MK-0859-051 AM1)

Dyslipidemia Clinical Trial

Official title:

A Multicenter, 24-Week, Double-Blind, Randomized, Placebo-Controlled, Phase III Study With 28-Week Open Labeled Extension Period to Assess the Efficacy and Safety of MK-0859 When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Japanese Patients With Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01760460
• Other study ID #: 0859-051
• Secondary ID: 132236
• Status: Completed
• Phase: Phase 3
• First received: January 2, 2013
• Last updated: May 31, 2017
• Start date: March 14, 2013
• Est. completion date: March 4, 2015

Study information

• Verified date: May 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 dyslipidemia when added to an existing statin-modifying therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: March 4, 2015
• Est. primary completion date: March 4, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• If female, cannot be of reproductive potential

• Treatment with an appropriate, stable dose of statin ± other lipid modifying therapy for at least 6 weeks and who is not at LDL-C goal per their category in the Japan Atherosclerosis Society guidelines

Exclusion Criteria:

• Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor

• Homozygous and heterozygous 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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• Anacetrapib

• Placebo for anacetrapib

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Teramoto T, Daida H, Ikewaki K, Arai H, Maeda Y, Nakagomi M, Shirakawa M, Watanabe Y, Kakikawa T, Numaguchi H, Johnson-Levonas AO, Blaustein RO. Lipid-modifying efficacy and tolerability of anacetrapib added to ongoing statin therapy in Japanese patients — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)		Baseline and Week 24
Primary	Percentage of Participants who Experience at Least One Adverse Event (AE)		64 weeks
Secondary	Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C)		Baseline and Week 24
Secondary	Percent Change from Baseline in Non-HDL-C		Baseline and Week 24
Secondary	Percent Change from Baseline in Apolipoprotein B (Apo-B)		Baseline and Week 24
Secondary	Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)		Baseline and Week 24
Secondary	Percent Change from Baseline in Lipoprotein(a) (Lp[a])		Baseline and Week 24