A Study of MK6213 Co-Administered With Atorvastatin in Patients With Hypercholesterolemia - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00687271

Purpose

The purpose of this study is to test the safety and effectiveness of MK6213 as compared to MK6213/Atorvastatin in patients (18 to 75 years) with high cholesterol.

Condition	Intervention	Phase
High Cholesterol	Drug: MK6213 Drug: Comparator: atorvastatin calcium Drug: Comparator: placebo (unspecified)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Efficacy, and Tolerability of MK6213 Co-Administered With Atorvastatin in Patients With Primary Hypercholesterolemia

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Calcium Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium Calcium gluconate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Evaluate the efficacy of MK6213 co-administered with atorvastatin compared to atorvastatin monotherapy in lowering LDL-C [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the safety and tolerability of MK6213 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	330
Study Start Date:	June 2008
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK6213 160mg	Drug: MK6213 MK6213 160mg for 4 weeks.
2: Experimental MK6213 160mg + atorvastatin 20mg	Drug: MK6213 MK6213 160mg for 4 weeks. Drug: Comparator: atorvastatin calcium atorvastatin calcium 20mg for 4 weeks.
3: Active Comparator atorvastatin 20mg	Drug: Comparator: atorvastatin calcium atorvastatin calcium 20mg for 4 weeks.
4: Placebo Comparator Placebo	Drug: Comparator: placebo (unspecified) Duration of Treatment: 4 Weeks

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is 18 to 75 years of age at the time of the study with high cholesterol
can have diabetes mellitus but is not currently on lipid lowering therapy
have a stable weight for >6 weeks

Exclusion Criteria:

Patient has significant cardiovascular (heart), renal (kidney), neurologic (nervous system), respiratory (lung), hepatic (liver) or metabolic disease
history of mental instability or drug/alcohol abuse within the past 5 years
pregnant or nursing; HIV positive; history of cancer within the past 5 years or participation in an investigational trial within the last 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687271

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_514, MK6213-006
Study First Received:	May 27, 2008
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00687271 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010