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Efficacy and Safety of Colesevelam in Pediatric Patients with Genetic High Cholesterol. - Article


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Cholesterol

 



Clinical Trial: Efficacy and Safety of Colesevelam in Pediatric Patients with Genetic High Cholesterol.

This study is not yet open for patient recruitment.
Verified by Sankyo Pharma Development September 2005

Sponsored by: Sankyo Pharma Development
Information provided by: Sankyo Pharma Development
ClinicalTrials.gov Identifier: NCT00145574

Purpose

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

MedlinePlus related topics:  Cholesterol

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

Official Title: Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Colesevelam HCl Administered to Pediatric Patients with Heterozygous Familial Hypercholesterolemia on a Stable Dose of Statins or Treatment Naive to Lipid-Lowering Therapy

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

Study start: October 2005

Eligibility

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

Location and Contact Information

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

More Information

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

Resources



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