Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151)
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
ezetimibe
simvastatin
Placebo (Unspecified)
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Coadministration arm: simvastatin 20mg and ezetimibe 10mg
Monotherapy arm: simvastatin 20mg and ezetimibe placebo
Outcomes
Primary Outcome Measures
Percentage reduction of LDL-C after 6 weeks of treatment.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00652444
Brief Title
Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151)
Official Title
Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief Summary
The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Coadministration arm: simvastatin 20mg and ezetimibe 10mg
Arm Title
2
Arm Type
Experimental
Arm Description
Monotherapy arm: simvastatin 20mg and ezetimibe placebo
Intervention Type
Drug
Intervention Name(s)
ezetimibe
Other Intervention Name(s)
Zetia®, EZETROL®, MK0653
Intervention Description
ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6.
Intervention Type
Drug
Intervention Name(s)
simvastatin
Other Intervention Name(s)
Zocor®, MK0733
Intervention Description
simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.
Intervention Type
Drug
Intervention Name(s)
Placebo (Unspecified)
Intervention Description
Matching ezetimibe placebo
Primary Outcome Measure Information:
Title
Percentage reduction of LDL-C after 6 weeks of treatment.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18545068
Citation
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.
Results Reference
background
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Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151)
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