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

This study has been terminated.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00092833
First received: September 23, 2004
Last updated: February 21, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Hypercholesterolemia, Familial
Lipid Metabolism, Inborn Errors
 Drug: Comparator: ezetimibe
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
Drug Information available for: Ezetimibe
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: July 2002
Study Completion Date: January 2006
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ezetimibe
 Drug: Comparator: ezetimibe
Ezetimibe (MK0653) 10 mg once daily for 3 years.

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092833

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092833     History of Changes
Other Study ID Numbers: MK-0653-026, 2004_034
Study First Received: September 23, 2004
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Genetic Diseases, Inborn
 Hyperlipoproteinemias
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013