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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014