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Sitosterolemia Extension Study (0653-003)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00092807
Recruitment Status : Completed
First Posted : September 28, 2004
Last Update Posted : February 16, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Lipid Metabolism, Inborn Errors Heart Disease Drug: MK0653, ezetimibe Drug: Comparator: placebo Phase 3

Detailed Description:
The duration of treatment is 52 weeks.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK0653 When Added to Current Regimen in Patients With Homozygous Sitosterolemia - 1 Year Open-Label Extension
Actual Study Start Date : February 12, 2001
Actual Primary Completion Date : September 18, 2001
Actual Study Completion Date : November 30, 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK0653 10 mg/day.

Secondary Outcome Measures :
  1. Assess the percent change relative to baseline in LDL-C/plasma campesterol concentrations, and safety and tolerability after long-term treatment with MK0653 10 mg/day in patients with homozygous sitosterolemia

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with elevated sitosterol levels while taking current medication

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.
Contacts and Locations
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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): NCT00092807


Sponsors and Collaborators
Organon and Co
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme LLC
More Information
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Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00092807    
Other Study ID Numbers: P02257
2004_032
First Posted: September 28, 2004    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022
Keywords provided by Organon and Co:
Homozygous Sitosterolemia
Additional relevant MeSH terms:
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Heart Diseases
Metabolism, Inborn Errors
Lipid Metabolism, Inborn Errors
Cardiovascular Diseases
Genetic Diseases, Inborn
Metabolic Diseases
Lipid Metabolism Disorders
 Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents