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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00687271
First Posted: May 30, 2008
Last Update Posted: September 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (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
  • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00687271


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00687271     History of Changes
Other Study ID Numbers: 6213-006
2007_514
First Submitted: May 27, 2008
First Posted: May 30, 2008
Last Update Posted: September 29, 2015
Last Verified: September 2015

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