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Atorvastatin Three Year Pediatric Study

Primary Purpose

Familial Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
atorvastatin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Familial Hypercholesterolemia focused on measuring pediatric heterozygous familial hypercholesterolemia

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Phoenix Children's Hospital
  • Children's National Medical Center
  • University of Florida
  • Johns Hopkins University
  • Johns Hopkins
  • MEDPACE Clinical Pharmacology Unit
  • The Children's Hospital of Philadelphia
  • Cliniques Universitaires Saint-Luc / Pediatrie generale
  • Universitaire Ziekenhuizen Leuven / Center for Metabolic Diseases
  • Clinique des maladies lipidiques de Quebec Inc
  • Clinique des Maladies Lipidiques de Quebec
  • Charite Campus Virchow-Klinikum
  • Augenaerztliche Gemeinschaftspraxis
  • 1st Pediatrics Clinic , University of Athens, Agia Sofia Hospital
  • Semmelweis Medical University
  • Fejer Megyei Szent Gyorgy Korhaz
  • Dipartimento di Medicina Clinica e delle Patologie Emergenti-University Hospital of Palermo
  • Dipartimento di Clinica e Terapia Medica, Università degli Studi di Roma La Sapienza
  • Rikshospitalet Lipidklinikken
  • Poradnia Chorob Metabolicznych
  • Klinika Chorob Metabolicznych
  • Hospital de la Concepcion
  • Moscow State Healthcare Institution 'Morozovskaya Children's City Clinical Hospital'
  • Saint-Petersburg State Pediatric Medical Academy
  • Saint-Petersburg State Healthcare Institution "Children's Polyclinic #35"
  • Autonomous Non-Profit Organization Medical Center 21 Century
  • Metabolicka ambulancia, 2. Detská klinika Lekárskej fakulty Univerzity Komenského
  • Detska fakultna nemocnica Kosice-old
  • Detska fakultna nemocnica Kosice
  • Lipmet, s.r.o.
  • Fakultna nemocnica Trencin
  • Hospital General Universitario de Elche
  • Hospital de Merida
  • Hospital Universitario Marques de Valdecilla
  • Hospital Santa Creu I Sant Pau
  • Hospital Sant Joan de Deu
  • Dr. med. Jean-Marc Nuoffer
  • Hacettepe University Medical Faculty. Department of Pediatrics. Nutrition and Metabolism Unit
  • Gazi University, Medical Faculty
  • Ege University Medical Faculty

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atorvastatin

Arm Description

All subjects will be treated with atorvastatin

Outcomes

Primary Outcome Measures

Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Percent Change From Baseline in LDL-C
Assessments were performed in the fasting state (minimum 10-hour fast).
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Percent Change From Baseline in HDL-C
Assessments were performed in the fasting state (minimum 10-hour fast).
Total Cholesterol (mMol/L) During the Study
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Percent Change From Baseline in Total Cholesterol
Assessments were performed in the fasting state (minimum 10-hour fast).
Trigylcerides (mMol/L) During the Study
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Percent Change From Baseline in Trigylcerides
Assessments were performed in the fasting state (minimum 10-hour fast).
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Percent Change From Baseline in VLDL
Assessments were performed in the fasting state (minimum 10-hour fast).
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Percent Change From Baseline in Apo A-1
Assessments were performed in the fasting state (minimum 10-hour fast).
Apoliprotein B (Apo B; g/L) During the Study
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Percent Change From Baseline in Apo B
Assessments were performed in the fasting state (minimum 10-hour fast).
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage
Tanner_Stage was assessed based on 2 components by gender, pubic hair and breasts for females and pubic hair and genitalia for males. If these values of components were not same, then the Tanner_Stage had the higher value of 2 components for each gender by visit.
Height (Centimeters [cm]) During the Study: Males
Investigator assessment of height changes during the study. Change from baseline was also determined.
Percent Change From Baseline in Height: Males
Investigator assessment of height changes during the study.
Height (cm) During the Study: Females
Investigator assessment of height changes during the study. Change from baseline was also determined.
Percent Change From Baseline in Height: Females
Investigator assessment of height changes during the study.
Weight (Kilograms [kg]) During the Study: Males
Investigator assessment of weight changes during the study. Change from baseline was also determined.
Percent Change From Baseline in Weight: Males
Investigator assessment of weight changes during the study.
Weight (kg) During the Study: Females
Investigator assessment of weight changes during the study. Change from baseline was also determined.
Percent Change From Baseline in Weight: Females
Investigator assessment of weight changes during the study.
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males
Investigator assessment of BMI changes during the study. Change from baseline was also determined.
Percent Change From Baseline in BMI: Males
Investigator assessment of BMI changes during the study.
BMI (kg/m^2) During the Study: Females
Investigator assessment of BMI changes during the study. Change from baseline was also determined.
Percent Change From Baseline in BMI: Females
Investigator assessment of BMI changes during the study.
Age (Years) During the Study: Males
Investigator assessment of age during the study. Change from baseline was also determined.
Percent Change From Baseline in Age: Males
Investigator assessment of age during the study.
Age (Years) During the Study: Females
Investigator assessment of age during the study. Change from baseline was also determined.
Percent Change From Baseline in Age: Females
Investigator assessment of age during the study.
Flow-Mediated Dilatation (FMD) During the Study
Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. Change from baseline was also determined.
Percent Change From Baseline in FMD
Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100.

Secondary Outcome Measures

Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator
Percentage of Participants by Study Drug Compliance Category
Compliance to study drug was categorized as <80%, 80% - 120%, and greater than (>) 120%.

Full Information

First Posted
January 21, 2009
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00827606
Brief Title
Atorvastatin Three Year Pediatric Study
Official Title
A Three Year, Prospective, Open-label, Study To Evaluate Clinical Efficacy, Safety And Tolerability Of Atorvastatin In Children And Adolescents With Heterozygous Familial Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Hypercholesterolemia
Keywords
pediatric heterozygous familial hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
All subjects will be treated with atorvastatin
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Intervention Description
Atorvastatin tablets or chewable tablets, 5, 10, 20, 40 mg strengths, once daily, for three years (an 80 mg maximum daily dose is delivered by taking two 40 mg strengths, once daily)
Primary Outcome Measure Information:
Title
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study
Description
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])
Title
Percent Change From Baseline in LDL-C
Description
Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)
Title
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study
Description
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Percent Change From Baseline in HDL-C
Description
Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Total Cholesterol (mMol/L) During the Study
Description
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Percent Change From Baseline in Total Cholesterol
Description
Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Trigylcerides (mMol/L) During the Study
Description
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Percent Change From Baseline in Trigylcerides
Description
Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study
Description
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Percent Change From Baseline in VLDL
Description
Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study
Description
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Percent Change From Baseline in Apo A-1
Description
Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Apoliprotein B (Apo B; g/L) During the Study
Description
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Percent Change From Baseline in Apo B
Description
Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage
Description
Tanner_Stage was assessed based on 2 components by gender, pubic hair and breasts for females and pubic hair and genitalia for males. If these values of components were not same, then the Tanner_Stage had the higher value of 2 components for each gender by visit.
Time Frame
Baseline, Months 6, 12, 18, 24, 30, and 36/ET
Title
Height (Centimeters [cm]) During the Study: Males
Description
Investigator assessment of height changes during the study. Change from baseline was also determined.
Time Frame
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Percent Change From Baseline in Height: Males
Description
Investigator assessment of height changes during the study.
Time Frame
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Height (cm) During the Study: Females
Description
Investigator assessment of height changes during the study. Change from baseline was also determined.
Time Frame
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Percent Change From Baseline in Height: Females
Description
Investigator assessment of height changes during the study.
Time Frame
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Weight (Kilograms [kg]) During the Study: Males
Description
Investigator assessment of weight changes during the study. Change from baseline was also determined.
Time Frame
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Percent Change From Baseline in Weight: Males
Description
Investigator assessment of weight changes during the study.
Time Frame
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Weight (kg) During the Study: Females
Description
Investigator assessment of weight changes during the study. Change from baseline was also determined.
Time Frame
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Percent Change From Baseline in Weight: Females
Description
Investigator assessment of weight changes during the study.
Time Frame
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males
Description
Investigator assessment of BMI changes during the study. Change from baseline was also determined.
Time Frame
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Percent Change From Baseline in BMI: Males
Description
Investigator assessment of BMI changes during the study.
Time Frame
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
BMI (kg/m^2) During the Study: Females
Description
Investigator assessment of BMI changes during the study. Change from baseline was also determined.
Time Frame
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Percent Change From Baseline in BMI: Females
Description
Investigator assessment of BMI changes during the study.
Time Frame
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Age (Years) During the Study: Males
Description
Investigator assessment of age during the study. Change from baseline was also determined.
Time Frame
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Percent Change From Baseline in Age: Males
Description
Investigator assessment of age during the study.
Time Frame
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Age (Years) During the Study: Females
Description
Investigator assessment of age during the study. Change from baseline was also determined.
Time Frame
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Percent Change From Baseline in Age: Females
Description
Investigator assessment of age during the study.
Time Frame
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Title
Flow-Mediated Dilatation (FMD) During the Study
Description
Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. Change from baseline was also determined.
Time Frame
Baseline, Months 6, 12, 18, 24, 30 and 36/ET
Title
Percent Change From Baseline in FMD
Description
Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100.
Time Frame
Months 6, 12, 18, 24, 30 and 36/ET
Secondary Outcome Measure Information:
Title
Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator
Time Frame
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination)
Title
Percentage of Participants by Study Drug Compliance Category
Description
Compliance to study drug was categorized as <80%, 80% - 120%, and greater than (>) 120%.
Time Frame
Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
MEDPACE Clinical Pharmacology Unit
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Cliniques Universitaires Saint-Luc / Pediatrie generale
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven / Center for Metabolic Diseases
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Clinique des maladies lipidiques de Quebec Inc
City
Sainte-Foy,
State/Province
Quebec
ZIP/Postal Code
G1V 4M6
Country
Canada
Facility Name
Clinique des Maladies Lipidiques de Quebec
City
Quebec
ZIP/Postal Code
G1V 4M6
Country
Canada
Facility Name
Charite Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Augenaerztliche Gemeinschaftspraxis
City
Freiburg
ZIP/Postal Code
79098
Country
Germany
Facility Name
1st Pediatrics Clinic , University of Athens, Agia Sofia Hospital
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Semmelweis Medical University
City
Budapest
ZIP/Postal Code
H-1094
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Korhaz
City
Szekesfehervar
ZIP/Postal Code
8003
Country
Hungary
Facility Name
Dipartimento di Medicina Clinica e delle Patologie Emergenti-University Hospital of Palermo
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Dipartimento di Clinica e Terapia Medica, Università degli Studi di Roma La Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Rikshospitalet Lipidklinikken
City
Oslo
ZIP/Postal Code
0027
Country
Norway
Facility Name
Poradnia Chorob Metabolicznych
City
Bydgoszcz
ZIP/Postal Code
85-667
Country
Poland
Facility Name
Klinika Chorob Metabolicznych
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Hospital de la Concepcion
City
San German
ZIP/Postal Code
683
Country
Puerto Rico
Facility Name
Moscow State Healthcare Institution 'Morozovskaya Children's City Clinical Hospital'
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Saint-Petersburg State Pediatric Medical Academy
City
Saint-Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
Saint-Petersburg State Healthcare Institution "Children's Polyclinic #35"
City
Saint-Petersburg
ZIP/Postal Code
196084
Country
Russian Federation
Facility Name
Autonomous Non-Profit Organization Medical Center 21 Century
City
St Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Metabolicka ambulancia, 2. Detská klinika Lekárskej fakulty Univerzity Komenského
City
Bratislava
ZIP/Postal Code
833 40
Country
Slovakia
Facility Name
Detska fakultna nemocnica Kosice-old
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
Detska fakultna nemocnica Kosice
City
Kosice
ZIP/Postal Code
040 11
Country
Slovakia
Facility Name
Lipmet, s.r.o.
City
Poprad
ZIP/Postal Code
05801
Country
Slovakia
Facility Name
Fakultna nemocnica Trencin
City
Trencin
ZIP/Postal Code
911 71
Country
Slovakia
Facility Name
Hospital General Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03202
Country
Spain
Facility Name
Hospital de Merida
City
Merida
State/Province
Badajoz
ZIP/Postal Code
6800
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Sant Joan de Deu
City
Esplugues de Llobregat
ZIP/Postal Code
08950
Country
Spain
Facility Name
Dr. med. Jean-Marc Nuoffer
City
Ch-3010 Bern
Country
Switzerland
Facility Name
Hacettepe University Medical Faculty. Department of Pediatrics. Nutrition and Metabolism Unit
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Gazi University, Medical Faculty
City
Ankara
ZIP/Postal Code
6500
Country
Turkey
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
27678432
Citation
Langslet G, Breazna A, Drogari E. A 3-year study of atorvastatin in children and adolescents with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2016 Sep-Oct;10(5):1153-1162.e3. doi: 10.1016/j.jacl.2016.05.010. Epub 2016 Jun 7.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581173&StudyName=Atorvastatin%20Three%20Year%20Pediatric%20Study
Description
To obtain contact information for a study center near you, click here.

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Atorvastatin Three Year Pediatric Study

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