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An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

NCT02890992 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2019-09-06

Study results available
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Summary

Primary Objective:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants aged of 8 to 17 years, with LDL-C \>=130 milligrams per deciliter (mg/dL) (3.37 millimoles per litre \[mmol/L\]) on optimal stable daily dose of statin therapy +/- other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins for at least 4 weeks prior to the screening period.

Secondary Objective:

* To evaluate the safety and tolerability of alirocumab.
* To evaluate the pharmacokinetics profile of alirocumab.
* To evaluate the effects of alirocumab on other lipid parameters.

Conditions

  • Hypercholesterolaemia

Interventions

DRUG

alirocumab SAR236553 (REGN727)

Pharmaceutical form: solution Route of administration: subcutaneous injection

DRUG

statins

Pharmaceutical form: tablet Route of administration: oral

DRUG

ezetimibe

Pharmaceutical form:tablet Route of administration: oral

DRUG

cholestyramine

Pharmaceutical form:tablet Route of administration: oral

DRUG

fenofibrate

Pharmaceutical form: tablet Route of administration: oral

DRUG

omega-3 fatty acids

Pharmaceutical form: tablet Route of administration: oral

DRUG

nicotinic acid

Pharmaceutical form: tablet Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-15
Primary Completion
2018-09-13
Completion
2019-02-22

Countries

  • United States
  • Canada
  • Czechia
  • France
  • Netherlands
  • Norway
  • Russia
  • South Africa
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02890992 on ClinicalTrials.gov