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

February 7, 2022 updated by: Organon and Co

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Coadministration arm: simvastatin 20mg and ezetimibe 10mg
Drug: ezetimibe
ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6.
Other Names:
  • Zetia®
  • MK0653
  • EZETROL®
Drug: simvastatin
simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.
Other Names:
  • Zocor®
  • MK0733
Experimental: 2
Monotherapy arm: simvastatin 20mg and ezetimibe placebo
Drug: simvastatin
simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.
Other Names:
  • Zocor®
  • MK0733
Drug: Placebo (Unspecified)
Matching ezetimibe placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 3, 2008

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0653-151
  • 2008_004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Sponsor/Collaborators

Locations

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