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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00145574
• Other study ID #: WEL-410
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2005
• Last updated: April 8, 2010
• Start date: November 2005
• Est. completion date: December 2007

Study information

• Verified date: April 2010
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustria: Federal Ministry for Health and WomenCanada: Health CanadaIsrael: Israeli Health Ministry Pharmaceutical AdministrationNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Norway: Norwegian Medicines AgencySouth Africa: Medicines Control CouncilSlovakia: State Institute for Drug ControlCzech Republic: State Institute for Drug ControlAustralia: Therapeutic Goods AdministrationNew Zealand: Medsafe (New Zealand Medicines and Medical Devices Safety Authority)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• colesevelam HCl
Tablets
• placebo
Matching Tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Israel,  Netherlands,  Norway,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks (week 8 - day 1)	No
Secondary	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.	8 weeks (week 8 - day 1)	No
Secondary	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.	8 weeks (week 8 - day 1)	No
Secondary	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.	8 weeks (week 8 - day 1)	No
Secondary	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.	8 weeks (week 8 - day 1)	No
Secondary	Percent Change in Plasma Apolipoprotien A-I (Apo A-1) From Day 1 (Study Baseline) to Week 8.	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.	8 weeks (week 8 - day 1)	No
Secondary	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.	8 weeks (week 8 - day 1)	No
Secondary	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.	26 weeks (week 26 - day 1)	No
Secondary	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.	26 weeks (week 26 - day 1)	No
Secondary	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.	26 weeks (week 26 - day 1)	No
Secondary	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.	26 weeks (week 26 - day 1)	No
Secondary	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.	26 weeks (week 26 - day 1)	No
Secondary	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.	26 weeks (week 26 - day 1)	No
Secondary	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.	26 weeks (week 26 - day 1)	No