Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet in Patients With Primary Hypercholesterolemia
What is being tested
Data Collection
Who is being recruted
Hypercholesterolemia+3
+ Hyperlipidemias
+ Metabolic Diseases
From 18 to 80 Years
+2 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: September 2002
Summary
Principal SponsorOrganon and Co
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2002
Actual date on which the first participant was enrolled.The duration of treatment is 4 months.
Official TitleA Multicenter, Randomized, Double-Blind, Placebo-Controlled, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet in Patients With Primary Hypercholesterolemia
Principal SponsorOrganon and Co
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
1398 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
HypercholesterolemiaHyperlipidemiasMetabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasLipid Metabolism Disorders
Criteria
1 inclusion criteria required to participate
High cholesterol
1 exclusion criteria prevent from participating
Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers