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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00652444
• Other study ID #: 0653-151
• Secondary ID: 2008_004
• Status: Completed
• Phase: Phase 4
• Start date: September 2003
• Est. completion date: August 2004

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• ezetimibe
ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6.
• simvastatin
simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.
• Placebo (Unspecified)
Matching ezetimibe placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage reduction of LDL-C after 6 weeks of treatment.		6 weeks