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Investigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia (0653-026)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00092833
Recruitment Status : Terminated
First Posted : September 28, 2004
Last Update Posted : February 28, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia, Familial Lipid Metabolism, Inborn Errors Drug: Comparator: ezetimibe Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2002
Primary Completion Date : May 2005
Study Completion Date : May 2005

Arm Intervention/treatment
Experimental: 1
Drug: Comparator: ezetimibe
Ezetimibe (MK0653) 10 mg once daily for 3 years.

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092833

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Additional Information:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092833     History of Changes
Other Study ID Numbers: 0653-026
First Posted: September 28, 2004    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Hyperlipoproteinemia Type II
Lipid Metabolism Disorders
Metabolic Diseases
Genetic Diseases, Inborn
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents