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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00977288
First received: September 14, 2009
Last updated: March 21, 2014
Last verified: March 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
Estimated Study Completion Date: June 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
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: March 21, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on April 20, 2014