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

Phase 4

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: simvastatin; Drug: ezetimibe; Drug: Placebo (Unspecified)

• Registration Number: NCT00652444
• Lead Sponsor: Organon and Co

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2004-08
• Study Completion: 2004-08
• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-03
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	simvastatin	Monotherapy arm: simvastatin 20mg and ezetimibe placebo
2	Placebo (Unspecified)	Monotherapy arm: simvastatin 20mg and ezetimibe placebo
1	ezetimibe	Coadministration arm: simvastatin 20mg and ezetimibe 10mg
1	simvastatin	Coadministration arm: simvastatin 20mg and ezetimibe 10mg

Primary Outcome Measures

Name	Time	Method
Percentage reduction of LDL-C after 6 weeks of treatment.	6 weeks