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: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

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

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

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

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on July 02, 2009

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