To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With High Cholesterol
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: ezetimibe (+) simvastatin (Drug); niacin (ER) tablet (Drug); ezetimibe/simvastatin + niacin (ER) (Drug); Placebo (unspecified) (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high
cholesterol.
Clinical Details
Official title: Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in non-HDL-C
Secondary outcome: Change in other lipid variables
Eligibility
Minimum age: 18 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient with LDL-C of 130 through 190 mg/dL and Triglycerides
- Patient willing to be on a low-cholesterol diet
Exclusion Criteria:
- Pregnant of lactating women or intending to become pregnant
- Patient with sensitivity or intolerance to ezetimibe, simvastatin, or
ezetimibe/simvastatin combination tablet
- Patient with sensitivity or intolerance to niacin, any component of niacin extended
release of aspirin
- Patient for whom discontinuation of existing lipid-lowering therapy poses an
unacceptable risk
Locations and Contacts
Additional Information
Starting date: November 2005
Ending date: February 2008
Last updated: January 3, 2008
|
