Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151)

Organon

Status and phase

Completed

Phase 4

Conditions

Hypercholesterolemia

Treatments

Drug: ezetimibe

Drug: Placebo (Unspecified)

Drug: simvastatin

Study type

Interventional

Funder types

Industry

Identifiers

0653-151

2008_004

Details and patient eligibility

About

The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.

Enrollment

120 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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