A Study of MK6213 Co-Administered With Atorvastatin in Patients With Hypercholesterolemia
Information source: Merck
Information obtained from ClinicalTrials.gov on November 03, 2008
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: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
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: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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
Toll Free Number, Phone: 1-888-577-8839
Merck Sharp & Dohme (Australia) Pty Ltd., South Granville NSW 2142, Australia; Recruiting
David Woolner, Phone: 64-9-523-6075
Merck Sharp & Dohme B.V., Bruxelles 1180, Belgium; Recruiting
Nathalie Schrameijer, Phone: 32-2-373-4310
MSD Finland Oy, Espoo 2151, Finland; Recruiting
Eero Helve, Phone: 358-9-804-65280
Msd Sharp & Dohme Gmbh, Haar 85540, Germany; Recruiting
Thomas Lang, Phone: 49-89-4561-1536
Merck Sharp & Dohme (New Zealand) Ltd.,, Auckland, New Zealand; Recruiting
David Woolner, Phone: 64-9523-6075
MSD (Norge) AS, Drammen 3011, Norway; Recruiting
Bard Rogstad, Phone: 47-32-20-7484
Call for Information, Tucson, Arizona 85741, United States; Recruiting
Call for Information, Chandler, Arizona 85225, United States; Recruiting
Call for Information, Pasadena, California 91106, United States; Recruiting
Frosst Laboratories Inc., Bogota, Cundinamarca, Colombia; Recruiting
Felipe Arbelaez, Phone: 57-1-592-4400
Call for Information, Louisville, Kentucky 40213, United States; Recruiting
Call for Information, West Yarmouth, Massachusetts 02673, United States; Recruiting
Call for Information, Troy, Michigan 48098, United States; Recruiting
Call for Information, Trenton, New Jersey 08611, United States; Recruiting
Call for Information, Berlin, New Jersey 08009, United States; Recruiting
Call for Information, San Antonio, Texas 78229, United States; Recruiting
Call for Information, Virginia Beach, Virginia 23455, United States; Recruiting
Call for Information, Norfolk, Virginia 23502, United States; Recruiting
Additional Information
Starting date: June 2008
Last updated: October 29, 2008
|
