NCT00977288

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2009

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

6 months

First QC Date

September 14, 2009

Last Update Submit

May 5, 2015

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • The percent change from baseline in Low Density Lipoprotein -Cholesterol at week 8

    8 weeks

Secondary Outcomes (1)

  • 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

Study Arms (10)

1

EXPERIMENTAL

MK0859 10 mg + placebo

Drug: anacetrapibDrug: Comparator: Placebo

2

EXPERIMENTAL

MK0859 40 mg + placebo

Drug: anacetrapibDrug: Comparator: Placebo

3

EXPERIMENTAL

MK0859 100 mg + placebo

Drug: anacetrapibDrug: Comparator: Placebo

4

EXPERIMENTAL

MK0859 300 mg + placebo

Drug: anacetrapibDrug: Comparator: Placebo

5

EXPERIMENTAL

MK0859 10 mg + atorvastatin 10mg

Drug: anacetrapibDrug: Comparator: atorvastatin

6

EXPERIMENTAL

MK0859 40 mg + atorvastatin 10mg

Drug: anacetrapibDrug: Comparator: atorvastatin

7

EXPERIMENTAL

MK0859 100 mg + atorvastatin 10mg

Drug: anacetrapibDrug: Comparator: atorvastatin

8

EXPERIMENTAL

MK0859 300 mg + atorvastatin 10mg

Drug: anacetrapibDrug: Comparator: atorvastatin

9

PLACEBO COMPARATOR

Placebo + atorvastatin 10mg

Drug: Comparator: atorvastatinDrug: Comparator: Placebo

10

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo

Interventions

anacetrapibDRUG

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

Also known as: MK0859
12345678
Comparator: atorvastatinDRUG

atorvastatin tablet, 10mg, once daily for 8 weeks

56789
Comparator: PlaceboDRUG

Placebo tablet, once daily for 8 weeks

1102349

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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):52-60. doi: 10.1016/j.atherosclerosis.2013.05.012. Epub 2013 Jun 5.

    PMID: 23958252RESULT

MeSH Terms

Conditions

Dyslipidemias

Interventions

anacetrapib

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2009

First Posted

September 15, 2009

Study Start

September 1, 2009

Primary Completion

March 1, 2010

Study Completion

April 1, 2014

Last Updated

May 6, 2015

Record last verified: 2015-05