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

Verified by: Merck, February 2009
First Received: May 27, 2008 | Last Updated: February 5, 2009 | Phase: Phase 2 | Start Date: June 2008
Overall Status: Completed | Estimated Enrollment: 330
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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...

Brief Summary

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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

  • Drug: MK6213
    • MK6213 160mg for 4 weeks.
  • Drug: Comparator: atorvastatin calcium
    • atorvastatin calcium 20mg for 4 weeks.
  • Drug: Comparator: placebo (unspecified)
    • Duration of Treatment: 4 Weeks

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • MK6213 160mg
  • Experimental: 2
    • MK6213 160mg + atorvastatin 20mg
  • Active Comparator: 3
    • atorvastatin 20mg
  • Placebo Comparator: 4
    • Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Evaluate the efficacy of MK6213 co-administered with atorvastatin compared to atorvastatin monotherapy in lowering LDL-C
    • Time Frame: 4 weeks
      Safety Issue?: No

Secondary Measures

  • Evaluate the safety and tolerability of MK6213
    • Time Frame: 4 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00687271

Study ID Number: 2007_514

ClinicalTrials.gov Identifier: NCT00687271

Health Authority: United States: Food and Drug Administration

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00687271