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

Study Overview
=================
Brief Summary
-----------------
The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.

Official Title
-----------------
Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: ezetimibe
* Drug: simvastatin
* Drug: Placebo (Unspecified)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Coadministration arm: simvastatin 20mg and ezetimibe 10mg | Drug: ezetimibe<br>* ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6.<br>* Other names: MK0653;Drug: simvastatin<br>* simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.<br>* Other names: MK0733;|
| Experimental: 2<br>Monotherapy arm: simvastatin 20mg and ezetimibe placebo | Drug: simvastatin<br>* simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.<br>* Other names: MK0733;Drug: Placebo (Unspecified)<br>* Matching ezetimibe placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage reduction of LDL-C after 6 weeks of treatment. |  | 6 weeks |