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Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol

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ClinicalTrials.gov Identifier: NCT00145574
Recruitment Status : Completed
First Posted : September 5, 2005
Results First Posted : January 26, 2010
Last Update Posted : April 15, 2010
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hypercholesterolemia Drug: colesevelam HCl Drug: placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : November 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: high dose colesevelam
colesevelam HCl 3.750 g
 Drug: colesevelam HCl
Tablets
Experimental: Low dose colesevelam
Low dose colesevelam 1.875 g
 Drug: colesevelam HCl
Tablets
Placebo Comparator: placebo
placebo comparator
 Drug: placebo
Matching Tablets


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8. [ Time Frame: 8 weeks (week 8 - day 1) ]
    Percent change in LDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline)to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.


Secondary Outcome Measures :
  1. Percent Change in Plasma Total Cholesterol (TC) From Day 1 (Study Baseline) to Week 8. [ Time Frame: 8 weeks (week 8 - day 1) ]
    Percent change in total cholesterol (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.

  2. Percent Change in Plasma Triglycerides (TG) From Day 1 (Study Baseline) to Week 8. [ Time Frame: 8 weeks (week 8 - day 1) ]
    Percent change in triglycerides (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.

  3. Percent Change in Plasma High-density Lipoprotein-cholesterol (HDL-C) From Day 1 (Study Baseline) to Week 8. [ Time Frame: 8 weeks (week 8 - day 1) ]
    Percent change in HDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.

  4. Percent Change in Plasma Non-high Density Lipoprotein-cholesterol (Non-HDL-C) From Day 1 (Study Baseline) to Week 8. [ Time Frame: 8 weeks (week 8 - day 1) ]
    Percent change in non-HDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.

  5. Percent Change in Plasma Apolipoprotien A-I (Apo A-1) From Day 1 (Study Baseline) to Week 8. [ Time Frame: 8 weeks (week 8 - day 1) ]
    Percent change in Apolipoprotien A-I (Apo A-1) (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.

  6. Percent Change in Plasma Apolipoprotein B (Apo B) From Day 1 (Study Baseline) to Week 8. [ Time Frame: 8 weeks (week 8 - day 1) ]
    Percent change in Apo B (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.

  7. Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Study Baseline (Day 1) to Week 26. [ Time Frame: 26 weeks (week 26 - day 1) ]
    Percent change in low-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.

  8. Percent Change in Total Cholesterol From Study Baseline (Day 1) to Week 26. [ Time Frame: 26 weeks (week 26 - day 1) ]
    Percent change in total cholesterol (TC) from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.

  9. Percent Change in Triglycerides From Study Baseline (Day 1) to Week 26. [ Time Frame: 26 weeks (week 26 - day 1) ]
    Percent change in triglycerides from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.

  10. Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Study Baseline (Day 1) to Week 26. [ Time Frame: 26 weeks (week 26 - day 1) ]
    Percent change in high-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.

  11. Percent Change in Non-high-density Lipoprotein Cholesterol From Study Baseline (Day 1) to Week 26. [ Time Frame: 26 weeks (week 26 - day 1) ]
    Percent change in non-high-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.

  12. Percent Change in Apolipoprotein A-I From Study Baseline (Day 1) to Week 26. [ Time Frame: 26 weeks (week 26 - day 1) ]
    Percent change in apolipoprotein A-I from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.

  13. Percent Change in Apolipoprotein B From Study Baseline (Day 1) to Week 26. [ Time Frame: 26 weeks (week 26 - day 1) ]
    Percent change in apolipoprotein B from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 interfere with the well-being of the patients
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145574


Locations
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United States, District of Columbia
Washington, District of Columbia, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New York
Bronx, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Wexford, Pennsylvania, United States
United States, Utah
Salt Lake City, Utah, United States
Australia
Camperdown NSW, Australia
Austria
Vienna, Austria
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Ontario
Toronto, Ontario, Canada
Canada, Quebec
Chicoutimi, Quebec, Canada
Laval, Quebec, Canada
Stefoy, Quebec, Canada
Israel
Holon, Israel
Jerusalem, Israel
Kefer Saba, Israel
Tel-Hashomer, Israel
Netherlands
Amsterdam, Netherlands
Rotterdam, Netherlands
Norway
Oslo, Norway
South Africa
Observatory, South Africa
Pretoria, South Africa
Tygerberg, South Africa
Sponsors and Collaborators
Daiichi Sankyo, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michael Melino, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00145574    
Other Study ID Numbers: WEL-410
First Posted: September 5, 2005    Key Record Dates
Results First Posted: January 26, 2010
Last Update Posted: April 15, 2010
Last Verified: April 2010
Keywords provided by Daiichi Sankyo, Inc.:
Pediatric
hypercholesterolemia
colesevelam
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Colesevelam Hydrochloride
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents