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Completed

NCT Number: NCT00145574

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

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Camperdown NSW, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colesevelam HCl

Drug

Tablets

Placebo

Drug

Matching Tablets

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 5, 2005
Registry last updated
Apr 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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