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

Daiichi Sankyo194 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

194

Conditions

Hypercholesterolemia

Interventions

colesevelam HClDRUG

Tablets

placeboDRUG

Matching Tablets

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (25)

Unnamed facility

Washington D.C., District of Columbia, United States

Unnamed facility

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8.

Percent change in LDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline)to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.

Time frame: 8 weeks (week 8 - day 1)

Secondary Outcomes

Percent Change in Plasma Total Cholesterol (TC) From Day 1 (Study Baseline) to Week 8.

Percent change in total cholesterol (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.

Time frame: 8 weeks (week 8 - day 1)

Percent Change in Plasma Triglycerides (TG) From Day 1 (Study Baseline) to Week 8.

Percent change in triglycerides (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.

Time frame: 8 weeks (week 8 - day 1)

Percent Change in Plasma High-density Lipoprotein-cholesterol (HDL-C) From Day 1 (Study Baseline) to Week 8.

Percent change in HDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.

Time frame: 8 weeks (week 8 - day 1)

Percent Change in Plasma Non-high Density Lipoprotein-cholesterol (Non-HDL-C) From Day 1 (Study Baseline) to Week 8.

Percent change in non-HDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.

Time frame: 8 weeks (week 8 - day 1)

Percent Change in Plasma Apolipoprotien A-I (Apo A-1) From Day 1 (Study Baseline) to Week 8.

Data from ClinicalTrials.gov

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Unnamed facility

New Hyde Park, New York, United States

Unnamed facility

New York, New York, United States

Unnamed facility

The Bronx, New York, United States

Unnamed facility

Cincinnati, Ohio, United States

Unnamed facility

Wexford, Pennsylvania, United States

Unnamed facility

Salt Lake City, Utah, United States

Unnamed facility

Camperdown NSW, Australia

Unnamed facility

Vienna, Austria

...and 15 more locations

Percent change in Apolipoprotien A-I (Apo A-1) (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.

Time frame: 8 weeks (week 8 - day 1)

Percent Change in Plasma Apolipoprotein B (Apo B) From Day 1 (Study Baseline) to Week 8.

Percent change in Apo B (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.

Time frame: 8 weeks (week 8 - day 1)

Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Study Baseline (Day 1) to Week 26.

Percent change in low-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.

Time frame: 26 weeks (week 26 - day 1)

Percent Change in Total Cholesterol From Study Baseline (Day 1) to Week 26.

Percent change in total cholesterol (TC) from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.

Time frame: 26 weeks (week 26 - day 1)

Percent Change in Triglycerides From Study Baseline (Day 1) to Week 26.

Percent change in triglycerides from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.

Time frame: 26 weeks (week 26 - day 1)

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Study Baseline (Day 1) to Week 26.

Percent change in high-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.

Time frame: 26 weeks (week 26 - day 1)

Percent Change in Non-high-density Lipoprotein Cholesterol From Study Baseline (Day 1) to Week 26.

Percent change in non-high-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.

Time frame: 26 weeks (week 26 - day 1)

Percent Change in Apolipoprotein A-I From Study Baseline (Day 1) to Week 26.

Percent change in apolipoprotein A-I from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.

Time frame: 26 weeks (week 26 - day 1)

Percent Change in Apolipoprotein B From Study Baseline (Day 1) to Week 26.

Percent change in apolipoprotein B from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.

Time frame: 26 weeks (week 26 - day 1)