Clinical Trial: An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated with Sitosterolemia

This study is currently recruiting patients.

Sponsored by: Merck
Information provided by: Merck

Purpose

This is a 6-month study with patients who have the rare disease, sitosterolemia which may result in heart-related diseases. These patients have unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study investigates whether absorption of these non-cholesterols can be reduced in these patients.

Condition Treatment or Intervention Phase
Lipid Metabolism, Inborn Errors
Heart Disease
 
Phase II
Phase III

MedlinePlus related topics:  Genetic Disorders;   Heart Diseases;   Heart Diseases--Prevention;   Metabolic Disorders

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Eligibility

Ages Eligible for Study:  18 Years   -   85 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • 18 years or older, with a history of elevated sitosterol levels and have received treatment for at least 6 months prior to study entry.

Exclusion Criteria:

  • Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.

Location and Contact Information

Toll Free Number      1-888-577-8839 

Arizona
      Call for information., Chandler,  Arizona,  85225,  United States; Recruiting

California
      Call for information., San Francisco,  California,  94143,  United States; No longer recruiting

Florida
      Call for information., Brandon,  Florida,  33511,  United States; No longer recruiting

      Call for information., Naples,  Florida,  34102,  United States; No longer recruiting

Indiana
      Call for information., Nappanee,  Indiana,  46550,  United States; No longer recruiting

Maryland
      Call for information., Bethesda,  Maryland,  20892,  United States; No longer recruiting

Minnesota
      Call for information., Edina,  Minnesota,  55435,  United States; No longer recruiting

New Jersey
      Call for information., Newark,  New Jersey,  07103,  United States; Recruiting

North Carolina
      Call for information., Wilmington,  North Carolina,  28412,  United States; No longer recruiting

Pennsylvania
      Call for International Site Informaton, Horsham,  Pennsylvania,  19044,  United States; Recruiting

      Call for information., Lancaster,  Pennsylvania,  17601,  United States; No longer recruiting

      Call for information., Pittsburg,  Pennsylvania,  15243,  United States; No longer recruiting

South Carolina
      Call for information., Due West,  South Carolina,  29639,  United States; No longer recruiting

More Information

Study ID Numbers:  2004_038
Record last reviewed:  April 2005
Last Updated:  April 7, 2005
Record first received:  September 23, 2004
ClinicalTrials.gov Identifier:  NCT00092898
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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