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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00092833
First Posted: September 28, 2004
Last Update Posted: February 28, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
September 23, 2004
September 28, 2004
February 28, 2017
July 2002
May 2005   (Final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00092833 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Investigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia (0653-026)(COMPLETED)
An Open-Label, Worldwide, Treatment Use Study to Provide Ezetimibe 10 Mg/Day to Patients With Homozygous Familial Hypercholesterolemia or Homozygous Sitosterolemia
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hypercholesterolemia, Familial
  • Lipid Metabolism, Inborn Errors
Drug: Comparator: ezetimibe
Ezetimibe (MK0653) 10 mg once daily for 3 years.
Experimental: 1
Ezetimibe
Intervention: Drug: Comparator: ezetimibe
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
49
May 2005
May 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
8 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00092833
0653-026
2004_034
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP