Back to resultsAn Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)
Primary Purpose
Lipid Metabolism, Inborn Errors, Heart Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0653, ezetimibe
Comparator: placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lipid Metabolism, Inborn Errors focused on measuring Sitosterolemia
Eligibility Criteria
Inclusion Criteria: 18 years or older, with a history of elevated sitosterol levels and have received treatment for at least 6 months prior to study entry. Exclusion Criteria: Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.
Sites / Locations
Outcomes
Primary Outcome Measures
Sitosterol concentrations after 26 weeks.
Secondary Outcome Measures
Campesterol concentrations; Achilles tendon thickness; safety and tolerability.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00092898
Brief Title
An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to An Ongoing Regimen of Ezetimibe 10 mg in Patients Homozygous Sitosterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
October 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
This is a 6-month study with patients who have the rare disease, sitosterolemia which may result in heart-related diseases. These patients have unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study investigates whether absorption of these non-cholesterols can be reduced in these patients.
Detailed Description
The duration of treatment is 26 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Metabolism, Inborn Errors, Heart Disease
Keywords
Sitosterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0653, ezetimibe
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo
Primary Outcome Measure Information:
Title
Sitosterol concentrations after 26 weeks.
Time Frame
After 26 weeks
Secondary Outcome Measure Information:
Title
Campesterol concentrations; Achilles tendon thickness; safety and tolerability.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older, with a history of elevated sitosterol levels and have received treatment for at least 6 months prior to study entry.
Exclusion Criteria:
Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in 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
Citations:
PubMed Identifier
18484971
Citation
Musliner T, Cselovszky D, Sirah W, McCrary Sisk C, Sapre A, Salen G, Lutjohann D, von Bergmann K. Efficacy and safety of ezetimibe 40 mg vs. ezetimibe 10 mg in the treatment of patients with homozygous sitosterolaemia. Int J Clin Pract. 2008 Jul;62(7):995-1000. doi: 10.1111/j.1742-1241.2008.01786.x. Epub 2008 May 14.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Snyopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)
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