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

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

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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