Inegy vs. the Doubling of Atorvastatin in High Risk Patients
Information source: Merck
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: Comparator: ezetimibe/simvastatin 10/40 mg (Drug); Comparator: atorvastatin 40 mg (Drug); Comparator: atorvastatin 20 mg (Drug)
Phase: Phase 3
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
Patients currently taking atorvastatin 20 mg will be switched to either atorvastatin 40mg or
ezetimibe/simvastatin 10/40. After 6 weeks of treatment, the percent reduction in
low-density lipoprotein cholesterol (LDL-C) will be assessed and compared between the two
treatment groups.
Clinical Details
Official title: A Randomized, Double-Blind, Active-Controlled Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk and Not Adequately Controlled With Atorvastatin: A Comparison of Switching to a Combination Tablet Ezetimibe/Simvastatin Versus Doubling the Baseline Dose of Atorvastatin
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: percent reduction in low-density lipoprotein cholesterol (LDL-C)
Secondary outcome: reduction in low-density lipoprotein cholesterol (LDL-C) to <70, <100 mg/dL goals
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who are either statin naive or on approved lipid lowering therapy for 6
weeks prior to study initiation
Exclusion Criteria:
- Females who are pregnant or breastfeeding
- Patient consumes more than 14 alcoholic beverages per week
- Patient has been treated with an investigational drug within the last 30 days
- Patient has congestive heart failure
- Patient has had gastric bypass
- Patient is newly diagnosed with type 1 or 2 diabetes
- Patient is HIV positive
- Patient has a history of drug or alcohol abuse within the last 5 years
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Merck Sharp & Dohme (I.A.) Corp, Selangor 46300, Malaysia; Recruiting
Nazrin Azli, Phone: 603-77181748
MSD Polska Sp. z o.o. Dzial Medyczny, Warszawa 00-867, Poland; Recruiting
Adam Czernik, Phone: 48 22 549-51-39
MSD Bucharest, Bucharest Sector 1, Romania; Recruiting
Marius R. Ursa, Phone: 4021 316 8353
Merck Sharp & Dohme De Espana, S.A.E., Madrid 28027, Spain; Recruiting
Jorge Gonzalez-Esteban, Phone: 34-91-3210-728
Call for Information, Arvada, Colorado 80005, United States; Recruiting
Call for Information, Iowa City, Iowa 52242, United States; Recruiting
Call for Information, Louisville, Kentucky 40205-3374, United States; Recruiting
Merck Sharp & Dohme, Peru S.R.L., Surquillo, Lima LIMA 34, Peru; Recruiting
Jorge Vinces, Phone: 511-411-5933
Call for Information, Springfield, Massachusetts 01103, United States; Recruiting
Call for Information, Dover, New Hampshire 03820-0000, United States; Recruiting
Call for Information, Elmer, New Jersey 08318, United States; Recruiting
Call for Information, Manhasset, New York 11030, United States; Recruiting
Call for Information, Harrisburg, North Carolina 28075, United States; Recruiting
Call for Information, Beaver, Pennsylvania 15009, United States; Recruiting
Call for Information, Bristol, Tennessee 37620-0000, United States; Recruiting
Call for Information, Richmond, Virginia 23294, United States; Recruiting
Additional Information
Starting date: August 2008
Last updated: October 16, 2009
|
