CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 39 enrolled
Drug / intervention
Atorvastatin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00739999
NCT00739999Phase 1Completed
CompareCT.gov

A 8-Week, Open-Label, Phase 1 Study To Evaluate Pharmacokinetics, Pharmacodynamics, Safety And Tolerability Of Atorvastatin In Children And Adolescents With Heterozygous Familial Hypercholesterolemia

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Aug 22, 2008·Updated Mar 15, 2021

In Brief

A Phase 1 clinical trial evaluating Atorvastatin for Pediatric Heterozygous Hypercholesterolemia. Completed, enrolled 39 participants across 3 sites in 3 countries.

Detailed Summary

To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in children and adolescents with heterozygous familial hypercholesterolemia

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPediatric Heterozygous Hypercholesterolemia
CountriesCanada, Greece, Norway
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 22, 2008
Enrollment StartDec 1, 2008
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.9 years ago

Interventions

Atorvastatindrug

6-10 years Tanner Stage 1 will be administered 5-mg daily dose of an atorvastatin pediatric tablet formulation. Dose may be doubled if subjects have not attained target LDL (\<3.35 mmol/L) after 4-week treatment.

Atorvastatindrug

10-17 years Tanner Stage 2 will be administered 10-mg daily dose of atorvastatin tablet formulation. Dose may be doubled if subjects have not attained target LDL (\<3.35 mmol/L) after 4-week treatment.