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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00977288
First received: September 14, 2009
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Dyslipidemia
Drug: anacetrapib
Drug: Comparator: atorvastatin
Drug: Comparator: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The percent change from baseline in Low Density Lipoprotein -Cholesterol at week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 408
Study Start Date: September 2009
Study Completion Date: April 2014
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK0859 10 mg + placebo
Drug: anacetrapib
10, 40 or 100 mg tablet of MK0859 , once daily for 8 weeks
Other Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: MK0859
Drug: Comparator: atorvastatin
atorvastatin tablet, 10mg, once daily for 8 weeks
Placebo Comparator: 9
Placebo + atorvastatin 10mg
Drug: Comparator: atorvastatin
atorvastatin tablet, 10mg, once daily for 8 weeks
Drug: Comparator: Placebo
Placebo tablet, once daily for 8 weeks
Placebo Comparator: 10
Placebo
Drug: Comparator: Placebo
Placebo tablet, once daily for 8 weeks

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977288

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00977288     History of Changes
Other Study ID Numbers: 0859-029, 2009_662
Study First Received: September 14, 2009
Last Updated: May 27, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Anacetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014