This study will evaluate the lipid-lowering effect and safety of colesevelam therapy administered to heterozygous familial pediatric patients 10 through 17 years of age who are on a stable dose of a pediatric-approved statin monotherapy (atorvastatin, lovastatin, simvastatin or pravastatin), or who are treatment naive to lipid-lowering therapy.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: colesevelam HCl	Phase IV

Further Study Details: 

Primary Outcomes: Percent change in plasma LDL-C from study baseline (Day 1)to Week 8.
Secondary Outcomes: Percent change in LDL-C from Week 8 to Week 26 and from study baseline (Day 1) to Week 26.
Expected Total Enrollment:  200

Ages Eligible for Study:  10 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Male or female patients
• Ages 10 to 17 years inclusive
• Diagnosis of heterozygous familial hypercholesterolemia
• On a stable dose of statin monotherapy or are treatment naive to lipid- lowering agents
• On a low-cholesterol diet

Exclusion Criteria:

• Patients should not have serious concomitant conditions that could interfere with the analysis of the results or that could intefere with the well-being of the patients

Please refer to this study by ClinicalTrials.gov identifier  NCT00145574

Caroline Janu      1-513-579-9911 

District of Columbia
      Washington,  District of Columbia,  United States
Missouri
      St. Louis,  Missouri,  United States
New York
      New Hyde Park,  New York,  United States
      New York,  New York,  United States
Ohio
      Cincinnati,  Ohio,  United States
Pennsylvania
      Wexford,  Pennsylvania,  United States
Utah
      Salt Lake City,  Utah,  United States
Austria
      Vienna,  Austria
Canada, British Columbia
      Vancouver,  British Columbia,  Canada
Canada, Ontario
      Toronto,  Ontario,  Canada
Canada, Quebec
      Stefoy,  Quebec,  Canada
      Chicoutimi,  Quebec,  Canada
      Laval,  Quebec,  Canada
Israel
      Kefer Saba,  Israel
      Holon,  Israel
      Tel Hashomer,  Israel
      Jerusalem,  Israel
Netherlands
      Rotterdam,  Netherlands
      Amsterdam,  Netherlands
Norway
      Oslo,  Norway
South Africa
      Tygerberg,  South Africa
      Pretoria,  South Africa
      Observatory,  South Africa

Study ID Numbers:  WEL-410
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00145574
Health Authority: United States: Food and Drug Administration; Austria: Federal Ministry for Health and Women; Canada: Health Canada; Israel: Israeli Health Ministry Pharmaceutical Administration; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Norway: Norwegian Medicines Agency; South Africa: Medicines Control Council
ClinicalTrials.gov processed this record on 2005-09-06