A Study of MK6213 Co-Administered With Atorvastatin in Patients With Hypercholesterolemia (MK-6213-006)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00687271
First received: May 27, 2008
Last updated: May 23, 2013
Last verified: May 2013
  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 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 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:


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

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
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK6213 160mg
Drug: MK6213
MK6213 160mg for 4 weeks.
Other Name: MK6213
Experimental: 2
MK6213 160mg + atorvastatin 20mg
Drug: MK6213
MK6213 160mg for 4 weeks.
Other Name: MK6213
Drug: Comparator: atorvastatin calcium
atorvastatin calcium 20mg for 4 weeks.
Other Names:
  • atorvastatin
  • LIPITOR ®
Active Comparator: 3
atorvastatin 20mg
Drug: Comparator: atorvastatin calcium
atorvastatin calcium 20mg for 4 weeks.
Other Names:
  • atorvastatin
  • LIPITOR ®
Placebo Comparator: 4
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 Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00687271     History of Changes
Other Study ID Numbers: 2007_514, MK6213-006
Study First Received: May 27, 2008
Last Updated: May 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
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 17, 2014