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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

Page last updated: August 23, 2015

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