Back to resultsInvestigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia (0653-026)(COMPLETED)
Primary Purpose
Hypercholesterolemia, Familial, Lipid Metabolism, Inborn Errors
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: ezetimibe
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia, Familial
Eligibility Criteria
Inclusion Criteria: Homozygous familial hypercholesterolemia or sitosterolemia Exclusion Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Ezetimibe
Outcomes
Primary Outcome Measures
Incidence of clinical and laboratory adverse experiences in in patients with homozygous FH or homozygous sitosterolemia taking ezetimibe 10 mg/day
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00092833
Brief Title
Investigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia (0653-026)(COMPLETED)
Official Title
An Open-Label, Worldwide, Treatment Use Study to Provide Ezetimibe 10 Mg/Day to Patients With Homozygous Familial Hypercholesterolemia or Homozygous Sitosterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Study Start Date
July 2002 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (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 purpose of this study is to provide an investigational drug to patients with a specific type of hypercholesterolemia (high cholesterol) or sitosterolemia (unusually high absorption of non-cholesterol sterols) in a treatment use setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Familial, Lipid Metabolism, Inborn Errors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Ezetimibe
Intervention Type
Drug
Intervention Name(s)
Comparator: ezetimibe
Intervention Description
Ezetimibe (MK0653) 10 mg once daily for 3 years.
Primary Outcome Measure Information:
Title
Incidence of clinical and laboratory adverse experiences in in patients with homozygous FH or homozygous sitosterolemia taking ezetimibe 10 mg/day
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Homozygous familial hypercholesterolemia or sitosterolemia
Exclusion Criteria:
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
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
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Investigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia (0653-026)(COMPLETED)
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