Atorvastatin Three Year Pediatric Study

Viatris

Status and phase: Completed; Phase 3

Conditions: Familial Hypercholesterolemia

Treatments: Drug: atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00827606

2008-006130-95 (EudraCT Number)

A2581173

Details and patient eligibility

About

The purpose of this study is to characterize three year descriptive growth and development (ie, height, weight, body mass index, Tanner Stage) and efficacy of cholesterol reduction in pediatric subjects with Heterozygous Familial Hypercholesterolemia receiving atorvastatin treatment.

Enrollment: 272 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Heterozygous familial hypercholesterolemia, ages 6-15, LDL greater than 4 mmol/l

Exclusion criteria

• Active liver disease or hepatic dysfunction, or persistent elevations of serum transaminases exceeding three times the upper limit of normal (ULN).

Female of childbearing potential who is not using adequate contraceptive measures or any female who is pregnant or breastfeeding. Any female who becomes pregnant during study participation will be immediately discontinued from treatment and counseled appropriately about the in utero exposure.

Known hypersensitivities to HMG-CoA reductase inhibitors

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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272 participants in 1 patient group

Atorvastatin

Experimental group

Description:

All subjects will be treated with atorvastatin

Treatment:

Drug: atorvastatin