A Study of MK6213 Co-Administered With Atorvastatin in Patients With Hypercholesterolemia (MK-6213-006)(COMPLETED)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: High Cholesterol
Intervention: MK6213 (Drug); Comparator: atorvastatin calcium (Drug); Comparator: placebo (unspecified) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Evaluate the efficacy of MK6213 co-administered with atorvastatin compared to atorvastatin monotherapy in lowering LDL-C
Secondary outcome: Evaluate the safety and tolerability of MK6213
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: June 2008
Last updated: August 18, 2015
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