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

NCT ID: NCT00652444

Last Updated: 2022-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2004-08-31

Brief Summary

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

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Coadministration arm: simvastatin 20mg and ezetimibe 10mg

Group Type: EXPERIMENTAL

ezetimibe

Intervention Type: DRUG

ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6.

simvastatin

Intervention Type: DRUG

simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.

2

Monotherapy arm: simvastatin 20mg and ezetimibe placebo

Group Type: EXPERIMENTAL

simvastatin

Intervention Type: DRUG

simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.

Placebo (Unspecified)

Intervention Type: DRUG

Matching ezetimibe placebo

Interventions

ezetimibe

ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6.

Intervention Type: DRUG

simvastatin

simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.

Intervention Type: DRUG

Placebo (Unspecified)

Matching ezetimibe placebo

Intervention Type: DRUG

Other Intervention Names

Zetia®; EZETROL®; MK0653; Zocor®; MK0733

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Zubaid M, Shakir DK, Bazargani N, Binbrek A, Gopal R, Al-Tamimi O, Bakir S. Effect of ezetimibe coadministration with simvastatin in a Middle Eastern population: a prospective, multicentre, randomized, double-blind, placebo-controlled trial. J Cardiovasc Med (Hagerstown). 2008 Jul;9(7):688-93. doi: 10.2459/JCM.0b013e3282f3a1b1.

Reference Type: BACKGROUND

PMID: 18545068 (View on PubMed)

Other Identifiers

2008_004

Identifier Type: -

Identifier Source: secondary_id

0653-151

Identifier Type: -

Identifier Source: org_study_id