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

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092833
First received: September 23, 2004
Last updated: February 21, 2012
Last verified: February 2012

September 23, 2004
February 21, 2012
July 2002
February 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 ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00092833 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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
January 2006
February 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
Both
8 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00092833
MK-0653-026, 2004_034
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2012

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