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

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.

Official 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

Conditions

Hypercholesterolemia

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Percent change in plasma LDL-C from study baseline (Day 1)to Week 8.

Secondary Outcome Measures:

• Percent change in LDL-C from Week 8 to Week 26 and from study baseline (Day 1) to Week 26.

Study Start

November 2005

Eligibility & Criteria

• Ages Eligible for Study: 10 Years – 17 Years
• Genders Eligible for Study: Both

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

Total Enrolment

144

Contact Details

Camperdown NSW, Australia; Recruiting

• Contact Daiichi Sankyo for more information
  

  All content and media on the HealthEngine Blog is created and published online for informational purposes only. It is not intended to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the guidance of your doctor or other qualified health professional with any questions you may have regarding your health or a medical condition. Never disregard the advice of a medical professional, or delay in seeking it because of something you have read on this Website. If you think you may have a medical emergency, call your doctor, go to the nearest hospital emergency department, or call the emergency services immediately.