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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00145574
First received: September 1, 2005
Last updated: April 8, 2010
Last verified: April 2010
History of Changes
  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
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Statins
U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • Percent Change in Plasma Total Cholesterol (TC) From Day 1 (Study Baseline) to Week 8. [ Time Frame: 8 weeks (week 8 - day 1) ] [ Designated as safety issue: No ]
    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.

  • Percent Change in Plasma Triglycerides (TG) From Day 1 (Study Baseline) to Week 8. [ Time Frame: 8 weeks (week 8 - day 1) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Percent Change in Plasma Apolipoprotein B (Apo B) From Day 1 (Study Baseline) to Week 8. [ Time Frame: 8 weeks (week 8 - day 1) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Percent Change in Total Cholesterol From Study Baseline (Day 1) to Week 26. [ Time Frame: 26 weeks (week 26 - day 1) ] [ Designated as safety issue: No ]
    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.

  • Percent Change in Triglycerides From Study Baseline (Day 1) to Week 26. [ Time Frame: 26 weeks (week 26 - day 1) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Percent Change in Non-high-density Lipoprotein Cholesterol From Study Baseline (Day 1) to Week 26. [ Time Frame: 26 weeks (week 26 - day 1) ] [ Designated as safety issue: No ]
    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.

  • Percent Change in Apolipoprotein A-I From Study Baseline (Day 1) to Week 26. [ Time Frame: 26 weeks (week 26 - day 1) ] [ Designated as safety issue: No ]
    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.

  • Percent Change in Apolipoprotein B From Study Baseline (Day 1) to Week 26. [ Time Frame: 26 weeks (week 26 - day 1) ] [ Designated as safety issue: No ]
    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.


Enrollment: 194
Study Start Date: November 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00145574

  Show 25 Study Locations
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided by Daiichi Sankyo Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael Melino, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00145574     History of Changes
Other Study ID Numbers: WEL-410
Study First Received: September 1, 2005
Results First Received: November 6, 2009
Last Updated: April 8, 2010
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
Slovakia: State Institute for Drug Control
Czech Republic: State Institute for Drug Control
Australia: Therapeutic Goods Administration
New Zealand: Medsafe (New Zealand Medicines and Medical Devices Safety Authority)

Keywords provided by Daiichi Sankyo Inc.:
Pediatric
hypercholesterolemia
colesevelam

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
 Hyperlipoproteinemias
Colesevelam
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013