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Tracking Information | |
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First Received Date ICMJE | September 23, 2004 |
Last Updated Date | June 2, 2006 |
Start Date ICMJE | July 2002 |
Current Primary Outcome Measures ICMJE |
Plasma lipid levels. |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00092833 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Investigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia |
Official Title ICMJE | An Open-Label, Worldwide, Treatment Use Study to Provide Ezetimibe 10 Mg/Day to Patients With Homozygous Familial Hypercholesterolemia or Homozygous Sitosterolemia |
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. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Safety Study |
Condition ICMJE |
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Intervention ICMJE | Drug: MK0653, ezetimibe / Duration of Treatment: 3 years |
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Active, not recruiting |
Enrollment ICMJE | 1600 |
Completion Date | |
Primary Completion Date | |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 8 Years and older |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID ICMJE | NCT00092833 |
Responsible Party | |
Study ID Numbers ICMJE | 2004_034 |
Study Sponsor ICMJE | Merck |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Merck |
Verification Date | September 2005 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |