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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00145574
Registration number
NCT00145574
Ethics application status
Date submitted
1/09/2005
Date registered
5/09/2005
Date last updated
15/04/2010
Titles & IDs
Public title
Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
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Scientific 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
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Secondary ID [1]
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WEL-410
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia
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Condition category
Condition code
Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - colesevelam HCl
Treatment: Drugs - placebo
Experimental: high dose colesevelam - colesevelam HCl 3.750 g
Experimental: Low dose colesevelam - Low dose colesevelam 1.875 g
Placebo comparator: placebo - placebo comparator
Treatment: Drugs: colesevelam HCl
Tablets
Treatment: Drugs: placebo
Matching Tablets
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8.
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Assessment method [1]
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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.
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Timepoint [1]
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8 weeks (week 8 - day 1)
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Secondary outcome [1]
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Percent Change in Plasma Total Cholesterol (TC) From Day 1 (Study Baseline) to Week 8.
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Assessment method [1]
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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.
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Timepoint [1]
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8 weeks (week 8 - day 1)
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Secondary outcome [2]
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Percent Change in Plasma Triglycerides (TG) From Day 1 (Study Baseline) to Week 8.
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Assessment method [2]
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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.
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Timepoint [2]
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8 weeks (week 8 - day 1)
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Secondary outcome [3]
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Percent Change in Plasma High-density Lipoprotein-cholesterol (HDL-C) From Day 1 (Study Baseline) to Week 8.
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Assessment method [3]
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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.
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Timepoint [3]
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8 weeks (week 8 - day 1)
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Secondary outcome [4]
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Percent Change in Plasma Non-high Density Lipoprotein-cholesterol (Non-HDL-C) From Day 1 (Study Baseline) to Week 8.
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Assessment method [4]
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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.
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Timepoint [4]
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8 weeks (week 8 - day 1)
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Secondary outcome [5]
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Percent Change in Plasma Apolipoprotien A-I (Apo A-1) From Day 1 (Study Baseline) to Week 8.
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Assessment method [5]
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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.
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Timepoint [5]
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8 weeks (week 8 - day 1)
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Secondary outcome [6]
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Percent Change in Plasma Apolipoprotein B (Apo B) From Day 1 (Study Baseline) to Week 8.
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Assessment method [6]
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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.
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Timepoint [6]
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8 weeks (week 8 - day 1)
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Secondary outcome [7]
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Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Study Baseline (Day 1) to Week 26.
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Assessment method [7]
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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.
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Timepoint [7]
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26 weeks (week 26 - day 1)
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Secondary outcome [8]
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Percent Change in Total Cholesterol From Study Baseline (Day 1) to Week 26.
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Assessment method [8]
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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.
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Timepoint [8]
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26 weeks (week 26 - day 1)
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Secondary outcome [9]
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Percent Change in Triglycerides From Study Baseline (Day 1) to Week 26.
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Assessment method [9]
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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.
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Timepoint [9]
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26 weeks (week 26 - day 1)
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Secondary outcome [10]
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Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Study Baseline (Day 1) to Week 26.
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Assessment method [10]
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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.
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Timepoint [10]
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26 weeks (week 26 - day 1)
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Secondary outcome [11]
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Percent Change in Non-high-density Lipoprotein Cholesterol From Study Baseline (Day 1) to Week 26.
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Assessment method [11]
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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.
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Timepoint [11]
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26 weeks (week 26 - day 1)
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Secondary outcome [12]
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Percent Change in Apolipoprotein A-I From Study Baseline (Day 1) to Week 26.
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Assessment method [12]
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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.
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Timepoint [12]
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26 weeks (week 26 - day 1)
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Secondary outcome [13]
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Percent Change in Apolipoprotein B From Study Baseline (Day 1) to Week 26.
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Assessment method [13]
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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.
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Timepoint [13]
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26 weeks (week 26 - day 1)
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Eligibility
Key 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
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Minimum age
10
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2007
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Sample size
Target
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Accrual to date
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Final
194
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Camperdown NSW
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Recruitment postcode(s) [1]
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- Camperdown NSW
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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District of Columbia
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Country [2]
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United States of America
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State/province [2]
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Missouri
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Country [3]
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United States of America
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State/province [3]
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New York
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Country [4]
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United States of America
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State/province [4]
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Ohio
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Country [5]
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United States of America
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State/province [5]
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Pennsylvania
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Country [6]
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United States of America
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State/province [6]
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Utah
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Country [7]
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Austria
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State/province [7]
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Vienna
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Country [8]
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Canada
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State/province [8]
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British Columbia
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Country [9]
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Canada
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State/province [9]
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Ontario
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Country [10]
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Canada
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State/province [10]
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Quebec
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Country [11]
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Israel
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State/province [11]
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Holon
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Israel
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State/province [12]
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Jerusalem
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Israel
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State/province [13]
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Kefer Saba
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Country [14]
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Israel
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State/province [14]
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Tel-Hashomer
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Netherlands
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State/province [15]
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Amsterdam
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Netherlands
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Rotterdam
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Norway
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Oslo
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South Africa
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Observatory
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South Africa
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State/province [19]
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Pretoria
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Country [20]
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South Africa
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State/province [20]
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Tygerberg
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Daiichi Sankyo
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00145574
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Fax
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00145574
Download to PDF