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

May 5, 2015 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

408

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
MK0859 10 mg + placebo
Drug: anacetrapib
10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks
Other Names:
  • MK0859
Drug: Comparator: Placebo
Placebo tablet, once daily for 8 weeks
Experimental: 2
MK0859 40 mg + placebo
Drug: anacetrapib
10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks
Other Names:
  • MK0859
Drug: Comparator: Placebo
Placebo tablet, once daily for 8 weeks
Experimental: 3
MK0859 100 mg + placebo
Drug: anacetrapib
10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks
Other Names:
  • MK0859
Drug: Comparator: Placebo
Placebo tablet, once daily for 8 weeks
Experimental: 4
MK0859 300 mg + placebo
Drug: anacetrapib
10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks
Other Names:
  • MK0859
Drug: Comparator: Placebo
Placebo tablet, once daily for 8 weeks
Experimental: 5
MK0859 10 mg + atorvastatin 10mg
Drug: anacetrapib
10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks
Other Names:
  • MK0859
Drug: Comparator: atorvastatin
atorvastatin tablet, 10mg, once daily for 8 weeks
Experimental: 6
MK0859 40 mg + atorvastatin 10mg
Drug: anacetrapib
10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks
Other Names:
  • MK0859
Drug: Comparator: atorvastatin
atorvastatin tablet, 10mg, once daily for 8 weeks
Experimental: 7
MK0859 100 mg + atorvastatin 10mg
Drug: anacetrapib
10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks
Other Names:
  • MK0859
Drug: Comparator: atorvastatin
atorvastatin tablet, 10mg, once daily for 8 weeks
Experimental: 8
MK0859 300 mg + atorvastatin 10mg
Drug: anacetrapib
10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks
Other Names:
  • MK0859
Drug: Comparator: atorvastatin
atorvastatin tablet, 10mg, once daily for 8 weeks
Placebo Comparator: 9
Placebo + atorvastatin 10mg
Drug: Comparator: Placebo
Placebo tablet, once daily for 8 weeks
Drug: Comparator: atorvastatin
atorvastatin tablet, 10mg, once daily for 8 weeks
Placebo Comparator: 10
Placebo
Drug: Comparator: Placebo
Placebo tablet, once daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

September 14, 2009

First Submitted That Met QC Criteria

September 14, 2009

First Posted (Estimate)

September 15, 2009

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0859-029
  • 2009_662

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dyslipidemia

Clinical Trials on anacetrapib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe