Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol

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Daiichi Sankyo

Status and phase

Completed
Phase 4

Conditions

Hypercholesterolemia

Treatments

Drug: placebo
Drug: colesevelam HCl

Study type

Interventional

Funder types

Industry

Identifiers

NCT00145574
WEL-410

Details and patient eligibility

About

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.

Enrollment

194 patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

194 participants in 3 patient groups, including a placebo group

high dose colesevelam
Experimental group
Description:
colesevelam HCl 3.750 g
Treatment:
Drug: colesevelam HCl
Low dose colesevelam
Experimental group
Description:
Low dose colesevelam 1.875 g
Treatment:
Drug: colesevelam HCl
placebo
Placebo Comparator group
Description:
placebo comparator
Treatment:
Drug: placebo

Trial contacts and locations

25

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Data sourced from clinicaltrials.gov

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