CompletedPhase 3

Atorvastatin Three Year Pediatric Study

United States, Belgium, Canada272 participantsStarted 2009-03

Plain-language summary

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.

Who can participate

Age range

6 Years – 15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])

Percent Change From Baseline in LDL-C

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)

High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Percent Change From Baseline in HDL-C

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Total Cholesterol (mMol/L) During the Study

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Percent Change From Baseline in Total Cholesterol

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Trigylcerides (mMol/L) During the Study

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Trial details

NCT IDNCT00827606

SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-10

Results submitted2014-09-11

View on ClinicalTrials.gov More Familial Hypercholesterolemia trials

Who can participate

Age range

6 Years – 15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])

Percent Change From Baseline in LDL-C

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)

High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Percent Change From Baseline in HDL-C

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Total Cholesterol (mMol/L) During the Study

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Percent Change From Baseline in Total Cholesterol

Timeframe: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET

Trigylcerides (mMol/L) During the Study

Timeframe: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET