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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00145574




Trial ID
NCT00145574
Ethics application status
Date submitted
1/09/2005
Date registered
1/09/2005
Date last updated
8/04/2010

Titles & IDs
Public title
Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
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
Secondary ID [1] 0 0
WEL-410
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
8 weeks (week 8 - day 1)
Secondary outcome [1] 0 0
Percent Change in Plasma Total Cholesterol (TC) From Day 1 (Study Baseline) to Week 8. - 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.
Timepoint [1] 0 0
8 weeks (week 8 - day 1)
Secondary outcome [2] 0 0
Percent Change in Plasma Triglycerides (TG) From Day 1 (Study Baseline) to Week 8. - 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.
Timepoint [2] 0 0
8 weeks (week 8 - day 1)
Secondary outcome [3] 0 0
Percent Change in Plasma High-density Lipoprotein-cholesterol (HDL-C) From Day 1 (Study Baseline) to Week 8. - 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.
Timepoint [3] 0 0
8 weeks (week 8 - day 1)
Secondary outcome [4] 0 0
Percent Change in Plasma Non-high Density Lipoprotein-cholesterol (Non-HDL-C) From Day 1 (Study Baseline) to Week 8. - 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.
Timepoint [4] 0 0
8 weeks (week 8 - day 1)
Secondary outcome [5] 0 0
Percent Change in Plasma Apolipoprotien A-I (Apo A-1) From Day 1 (Study Baseline) to Week 8. - 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.
Timepoint [5] 0 0
8 weeks (week 8 - day 1)
Secondary outcome [6] 0 0
Percent Change in Plasma Apolipoprotein B (Apo B) From Day 1 (Study Baseline) to Week 8. - 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.
Timepoint [6] 0 0
8 weeks (week 8 - day 1)
Secondary outcome [7] 0 0
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Study Baseline (Day 1) to Week 26. - 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.
Timepoint [7] 0 0
26 weeks (week 26 - day 1)
Secondary outcome [8] 0 0
Percent Change in Total Cholesterol From Study Baseline (Day 1) to Week 26. - 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.
Timepoint [8] 0 0
26 weeks (week 26 - day 1)
Secondary outcome [9] 0 0
Percent Change in Triglycerides From Study Baseline (Day 1) to Week 26. - 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.
Timepoint [9] 0 0
26 weeks (week 26 - day 1)
Secondary outcome [10] 0 0
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Study Baseline (Day 1) to Week 26. - 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.
Timepoint [10] 0 0
26 weeks (week 26 - day 1)
Secondary outcome [11] 0 0
Percent Change in Non-high-density Lipoprotein Cholesterol From Study Baseline (Day 1) to Week 26. - 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.
Timepoint [11] 0 0
26 weeks (week 26 - day 1)
Secondary outcome [12] 0 0
Percent Change in Apolipoprotein A-I From Study Baseline (Day 1) to Week 26. - 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.
Timepoint [12] 0 0
26 weeks (week 26 - day 1)
Secondary outcome [13] 0 0
Percent Change in Apolipoprotein B From Study Baseline (Day 1) to Week 26. - 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.
Timepoint [13] 0 0
26 weeks (week 26 - day 1)

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
Minimum age
10 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Camperdown NSW
Recruitment postcode(s) [1] 0 0
- Camperdown NSW
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
District of Columbia
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah
Country [7] 0 0
Austria
State/province [7] 0 0
Vienna
Country [8] 0 0
Canada
State/province [8] 0 0
British Columbia
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
Israel
State/province [11] 0 0
Holon
Country [12] 0 0
Israel
State/province [12] 0 0
Jerusalem
Country [13] 0 0
Israel
State/province [13] 0 0
Kefer Saba
Country [14] 0 0
Israel
State/province [14] 0 0
Tel-Hashomer
Country [15] 0 0
Netherlands
State/province [15] 0 0
Amsterdam
Country [16] 0 0
Netherlands
State/province [16] 0 0
Rotterdam
Country [17] 0 0
Norway
State/province [17] 0 0
Oslo
Country [18] 0 0
South Africa
State/province [18] 0 0
Observatory
Country [19] 0 0
South Africa
State/province [19] 0 0
Pretoria
Country [20] 0 0
South Africa
State/province [20] 0 0
Tygerberg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Daiichi Sankyo, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00145574
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries