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

Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00977288
• Other study ID #: 0859-029
• Secondary ID: 2009_662
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2009
• Last updated: May 5, 2015
• Start date: September 2009
• Est. completion date: April 2014

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: April 2014
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• anacetrapib
10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks
• Comparator: atorvastatin
atorvastatin tablet, 10mg, once daily for 8 weeks
• Comparator: Placebo
Placebo tablet, once daily for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Teramoto T, Shirakawa M, Kikuchi M, Nakagomi M, Tamura S, Surks HK, McCrary Sisk C, Numaguchi H. Efficacy and safety of the cholesteryl ester transfer protein inhibitor anacetrapib in Japanese patients with dyslipidemia. Atherosclerosis. 2013 Sep;230(1):5 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percent change from baseline in Low Density Lipoprotein -Cholesterol at week 8		8 weeks	No
Secondary	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	No