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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: May 27, 2008
Last updated: September 25, 2015
Last verified: September 2015
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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:
  • Percent Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline and Week 4 ]

Secondary Outcome Measures:
  • Percentage of Participants who Experience at Least 1 Adverse Event [ Time Frame: up to 6 weeks ]
  • Percentage of Participants Who Were Discontinued from the Study Due to an Adverse Event [ Time Frame: up to 4 weeks ]

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.
Experimental: 2
MK6213 160mg + atorvastatin 20mg
Drug: MK6213
MK6213 160mg for 4 weeks.
Drug: Comparator: atorvastatin calcium
atorvastatin calcium 20mg for 4 weeks.
Other Names:
  • atorvastatin
Active Comparator: 3
atorvastatin 20mg
Drug: Comparator: atorvastatin calcium
atorvastatin calcium 20mg for 4 weeks.
Other Names:
  • atorvastatin
Placebo Comparator: 4
Drug: Comparator: placebo (unspecified)
Duration of Treatment: 4 Weeks


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00687271

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00687271     History of Changes
Other Study ID Numbers: 6213-006
Study First Received: May 27, 2008
Last Updated: September 25, 2015

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on May 25, 2017