A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029)

A Phase IIb, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Study to Assess the Efficacy and Safety of MK0859 in Japanese Patients With Dyslipidemia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00977288

Enrollment

408

Registered

2009-09-15

Start date

2009-09-30

Completion date

2014-04-30

Last updated

2015-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Brief summary

This study will investigate the effect of MK0859 when administered alone and when in combination with atorvastatin in lowering Low Density Lipoprotein -Cholesterol (LDL-C) in Japanese patients with dyslipidemia.

Detailed description

This is the dose ranging study to evaluate efficacy and safety of MK-0859 in Japanese patients. Eligible patients were assigned to 1 of 10 treatment groups (including treatment groups with or without administrative atorvastatin) for an 8-week treatment period which was followed by a 8-week reversibility period. As an additional follow-up, the pregnancy information from women of childbearing potential who were treated with MK-0859 in this study will be collected retrospectively for a period of 4 years after the last dose of MK-0859.

Interventions

DRUGanacetrapib

10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks

DRUGComparator: atorvastatin

atorvastatin tablet, 10mg, once daily for 8 weeks

DRUGComparator: Placebo

Placebo tablet, once daily for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patient is male or female and between the ages of 20 and 75 years diagnosed with dyslipidemia

Exclusion criteria

* Patients has Coronary Heart Disease (CHD) or CHD-equivalent disease (except diabetes) * Patients has uncontrolled diabetes * Patient is currently participating or has participated in a study with an investigational compound within the last 3 months

Design outcomes

Primary

Measure	Time frame
The percent change from baseline in Low Density Lipoprotein -Cholesterol at week 8	8 weeks

Secondary

Measure	Time frame
The percent change from baseline in High Density Lipoprotein-Cholesterol and safety (hepatitis related AEs, myalgia, rhabdomyolysis, blood pressure, laboratory tests: ALT, AST, CK, Na, Cl, bicarbonate, and K), at week 8	8 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026