Sitosterolemia Extension Study (0653-004)(COMPLETED)
NCT00092820 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2024-08-15
Summary
This is an extension study for patients having unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study will evaluate the long term safety and the ability to lower cholesterol levels with an investigational drug.
Conditions
- Lipid Metabolism, Inborn Errors
- Heart Disease
Interventions
- DRUG
-
MK0653, ezetimibe
- DRUG
-
Comparator: placebo
Sponsors & Collaborators
-
Organon and Co
lead INDUSTRY
Principal Investigators
-
Medical Monitor · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 10 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-02-12
- Primary Completion
- 2001-09-18
- Completion
- 2004-11-30
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