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

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:

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Merck:

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 ]

Estimated Enrollment:	400
Study Start Date:	September 2009
Study Completion Date:	May 2010
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

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

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00977288 History of Changes
Other Study ID Numbers:	2009_662, MK0859-029
Study First Received:	September 14, 2009
Last Updated:	August 2, 2010
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 May 16, 2013