Conditions: Hypercholesterolemia
Keywords: Pediatric hypercholesterolemia colesevelam
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 194
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: colesevelam HCl 3.750 g arm 2: Low dose colesevelam 1.875 g arm 3: placebo comparator

Interventions: intervention 1: colesevelam HCl intervention 2: placebo
Intervention descriptions: intervention 1: Tablets intervention 2: Matching Tablets

Protocol document: