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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
Sex
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
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2007
Sample size
Target
Accrual to date
Final
194
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
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/ct2/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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00145574