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

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.

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

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