Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial
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 (Drug); simvastatin (Drug); Placebo (Unspecified) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.
Clinical Details
Official title: Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percentage reduction of LDL-C after 6 weeks of treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with known Coronary Artery Disease (CAD) and primary hypercholesterolemia,
who are being treated with simvastatin 20mg. Simvastatin consumption meant that
subjects must be currently taking simvastatin 20mg daily, and by history have taken at
least 80% of daily evening doses for the preceding 6 weeks prior to baseline visit
- Age of at least 18 years and 75 years or less
- Calculated LDL-C concentration of at least 2. 6 and 4. 1mmol/l or less using the
Friedewald equation, and triglyceride of less than 3. 99 mmol/l
Exclusion Criteria:
- Congestive heart failure (defined as New York Heart Association class III or IV heart
failure)
- Uncontrolled cardiac arrhythmias
- Acute coronary syndrome, coronary bypass surgery or coronary angioplasty within 3
months of study entry
- History of unstable or severe peripheral artery disease within 3 months of study
entry
- Uncontrolled hypertension at study entry
- Uncontrolled or newly diagnosed diabetes mellitus (within 3 months of study entry)
- Uncontrolled endocrine or metabolic diseases known to influence serum lipids and
lipoproteins; known impairment of renal function
- Active or chronic hepatic and hepatobiliary disease
- Disorders that would limit study evaluation or participation
Locations and Contacts
Additional Information
Starting date: September 2003
Last updated: March 31, 2008
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