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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.

Tracking Information
First Submitted Date  ICMJE September 1, 2005
First Posted Date  ICMJE September 5, 2005
Results First Submitted Date  ICMJE November 6, 2009
Results First Posted Date  ICMJE January 26, 2010
Last Update Posted Date April 15, 2010
Study Start Date  ICMJE November 2005
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2009)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
Percent change in plasma LDL-C from study baseline (Day 1)to Week 8.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2009)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
Percent change in LDL-C from Week 8 to Week 26 and from study baseline (Day 1) to Week 26.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Drug: colesevelam HCl
    Tablets
  • Drug: placebo
    Matching Tablets
Study Arms  ICMJE
  • Experimental: high dose colesevelam
    colesevelam HCl 3.750 g
    Intervention: Drug: colesevelam HCl
  • Experimental: Low dose colesevelam
    Low dose colesevelam 1.875 g
    Intervention: Drug: colesevelam HCl
  • Placebo Comparator: placebo
    placebo comparator
    Intervention: Drug: placebo
Publications * Stein EA, Marais AD, Szamosi T, Raal FJ, Schurr D, Urbina EM, Hopkins PN, Karki S, Xu J, Misir S, Melino M. Colesevelam hydrochloride: efficacy and safety in pediatric subjects with heterozygous familial hypercholesterolemia. J Pediatr. 2010 Feb;156(2):231-6.e1-3. doi: 10.1016/j.jpeds.2009.08.037. Epub 2009 Oct 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2007)
194
Original Enrollment  ICMJE
 (submitted: September 1, 2005)
200
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   Israel,   Netherlands,   Norway,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00145574
Other Study ID Numbers  ICMJE WEL-410
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Melino, Daiichi Sankyo
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daiichi Sankyo, Inc.
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP