Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
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
1 other identifier
interventional
194
7 countries
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2005
Typical duration for phase_4
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 5, 2005
CompletedStudy Start
First participant enrolled
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
January 26, 2010
CompletedApril 15, 2010
April 1, 2010
2.1 years
September 1, 2005
November 6, 2009
April 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8.
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.
8 weeks (week 8 - day 1)
Secondary Outcomes (13)
Percent Change in Plasma Total Cholesterol (TC) From Day 1 (Study Baseline) to Week 8.
8 weeks (week 8 - day 1)
Percent Change in Plasma Triglycerides (TG) From Day 1 (Study Baseline) to Week 8.
8 weeks (week 8 - day 1)
Percent Change in Plasma High-density Lipoprotein-cholesterol (HDL-C) From Day 1 (Study Baseline) to Week 8.
8 weeks (week 8 - day 1)
Percent Change in Plasma Non-high Density Lipoprotein-cholesterol (Non-HDL-C) From Day 1 (Study Baseline) to Week 8.
8 weeks (week 8 - day 1)
Percent Change in Plasma Apolipoprotien A-I (Apo A-1) From Day 1 (Study Baseline) to Week 8.
8 weeks (week 8 - day 1)
- +8 more secondary outcomes
Study Arms (3)
high dose colesevelam
EXPERIMENTALcolesevelam HCl 3.750 g
Low dose colesevelam
EXPERIMENTALLow dose colesevelam 1.875 g
placebo
PLACEBO COMPARATORplacebo comparator
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (25)
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
New Hyde Park, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
The Bronx, New York, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Wexford, Pennsylvania, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Camperdown NSW, Australia
Unknown Facility
Vienna, Austria
Unknown Facility
Vancouver, British Columbia, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Chicoutimi, Quebec, Canada
Unknown Facility
Laval, Quebec, Canada
Unknown Facility
Stefoy, Quebec, Canada
Unknown Facility
Holon, Israel
Unknown Facility
Jerusalem, Israel
Unknown Facility
Kefer Saba, Israel
Unknown Facility
Tel Litwinsky, Israel
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Rotterdam, Netherlands
Unknown Facility
Oslo, Norway
Unknown Facility
Observatory, South Africa
Unknown Facility
Pretoria, South Africa
Unknown Facility
Tygerberg, South Africa
Related Publications (1)
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.
PMID: 19879596DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Howard Kessler
- Organization
- Daiichi Sankyo
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 1, 2005
First Posted
September 5, 2005
Study Start
November 1, 2005
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
April 15, 2010
Results First Posted
January 26, 2010
Record last verified: 2010-04