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Atorvastatin Three Year Pediatric Study

17. Februar 2021 aktualisiert von: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Three Year, Prospective, Open-label, Study To Evaluate Clinical Efficacy, Safety And Tolerability Of Atorvastatin In Children And Adolescents With Heterozygous Familial Hypercholesterolemia

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

272

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Belgien
      • Bruxelles, Belgien, 1200
        • Cliniques Universitaires Saint-Luc / Pediatrie generale
      • Leuven, Belgien, 3000
        • Universitaire Ziekenhuizen Leuven / Center for Metabolic Diseases
  • Deutschland
      • Berlin, Deutschland, 13353
        • Charité Campus Virchow-Klinikum
      • Freiburg, Deutschland, 79098
        • Augenaerztliche Gemeinschaftspraxis
  • Griechenland
      • Athens, Griechenland, 115 27
        • 1st Pediatrics Clinic , University of Athens, Agia Sofia Hospital
  • Italien
      • Palermo, Italien, 90127
        • Dipartimento di Medicina Clinica e delle Patologie Emergenti-University Hospital of Palermo
      • Roma, Italien, 00161
        • Dipartimento di Clinica e Terapia Medica, Università degli Studi di Roma La Sapienza
  • Kanada
      • Quebec, Kanada, G1V 4M6
        • Clinique des maladies lipidiques de Quebec
    • Quebec
      • Sainte-Foy,, Quebec, Kanada, G1V 4M6
        • Clinique des Maladies Lipidiques de Quebec Inc
  • Norwegen
      • Oslo, Norwegen, 0027
        • Rikshospitalet Lipidklinikken
  • Polen
      • Bydgoszcz, Polen, 85-667
        • Poradnia Chorob Metabolicznych
      • Warszawa, Polen, 04-730
        • Klinika Chorob Metabolicznych
  • Puerto Rico
      • San German, Puerto Rico, 683
        • Hospital de la Concepcion
  • Russische Föderation
      • Moscow, Russische Föderation, 119049
        • Moscow State Healthcare Institution 'Morozovskaya Children's City Clinical Hospital'
      • Saint-Petersburg, Russische Föderation, 194100
        • Saint-Petersburg State Pediatric Medical Academy
      • Saint-Petersburg, Russische Föderation, 196084
        • Saint-Petersburg State Healthcare Institution "Children's Polyclinic #35"
      • St Petersburg, Russische Föderation, 194044
        • Autonomous Non-Profit Organization Medical Center 21 Century
  • Schweiz
      • Ch-3010 Bern, Schweiz
        • Dr. med. Jean-Marc Nuoffer
  • Slowakei
      • Bratislava, Slowakei, 833 40
        • Metabolicka ambulancia, 2. Detská klinika Lekárskej fakulty Univerzity Komenského
      • Kosice, Slowakei, 040 01
        • Detska fakultna nemocnica Kosice-old
      • Kosice, Slowakei, 040 11
        • Detska fakultna nemocnica Kosice
      • Poprad, Slowakei, 05801
        • Lipmet, s.r.o.
      • Trencin, Slowakei, 911 71
        • Fakultna nemocnica Trencin
  • Spanien
      • Barcelona, Spanien, 08041
        • Hospital Santa Creu i Sant Pau
      • Esplugues de Llobregat, Spanien, 08950
        • Hospital Sant Joan de Deu
    • Alicante
      • Elche, Alicante, Spanien, 03202
        • Hospital General Universitario de Elche
    • Badajoz
      • Merida, Badajoz, Spanien, 6800
        • Hospital de Mérida
    • Cantabria
      • Santander, Cantabria, Spanien, 39008
        • Hospital Universitario Marqués de Valdecilla
  • Truthahn
      • Ankara, Truthahn, 06100
        • Hacettepe University Medical Faculty. Department of Pediatrics. Nutrition and Metabolism Unit
      • Ankara, Truthahn, 6500
        • Gazi University, Medical Faculty
      • Izmir, Truthahn, 35100
        • Ege University Medical Faculty
  • Ungarn
      • Budapest, Ungarn, H-1094
        • Semmelweis Medical University
      • Szekesfehervar, Ungarn, 8003
        • Fejer Megyei Szent Gyorgy Korhaz
  • Vereinigte Staaten
    • Arizona
      • Phoenix, Arizona, Vereinigte Staaten, 85016
        • Phoenix Children's Hospital
    • District of Columbia
      • Washington, District of Columbia, Vereinigte Staaten, 20010
        • Children's National Medical Center
    • Florida
      • Gainesville, Florida, Vereinigte Staaten, 32608
        • University of Florida
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21287
        • Johns Hopkins University
      • Baltimore, Maryland, Vereinigte Staaten, 21287
        • Johns Hopkins
    • Ohio
      • Cincinnati, Ohio, Vereinigte Staaten, 45212
        • Medpace Clinical Pharmacology Unit
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • The Children's Hospital of Philadelphia

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

6 Jahre bis 15 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Atorvastatin
All subjects will be treated with atorvastatin
Arzneimittel: atorvastatin
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)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study
Zeitfenster: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])
Percent Change From Baseline in LDL-C
Zeitfenster: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)
Assessments were performed in the fasting state (minimum 10-hour fast).
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study
Zeitfenster: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in HDL-C
Zeitfenster: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast).
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Total Cholesterol (mMol/L) During the Study
Zeitfenster: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Total Cholesterol
Zeitfenster: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast).
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Trigylcerides (mMol/L) During the Study
Zeitfenster: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Trigylcerides
Zeitfenster: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast).
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study
Zeitfenster: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in VLDL
Zeitfenster: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast).
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study
Zeitfenster: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Apo A-1
Zeitfenster: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast).
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Apoliprotein B (Apo B; g/L) During the Study
Zeitfenster: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Apo B
Zeitfenster: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast).
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage
Zeitfenster: Baseline, Months 6, 12, 18, 24, 30, and 36/ET
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.
Baseline, Months 6, 12, 18, 24, 30, and 36/ET
Height (Centimeters [cm]) During the Study: Males
Zeitfenster: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of height changes during the study. Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Height: Males
Zeitfenster: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of height changes during the study.
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Height (cm) During the Study: Females
Zeitfenster: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of height changes during the study. Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Height: Females
Zeitfenster: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of height changes during the study.
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Weight (Kilograms [kg]) During the Study: Males
Zeitfenster: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of weight changes during the study. Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Weight: Males
Zeitfenster: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of weight changes during the study.
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Weight (kg) During the Study: Females
Zeitfenster: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of weight changes during the study. Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Weight: Females
Zeitfenster: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of weight changes during the study.
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males
Zeitfenster: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of BMI changes during the study. Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in BMI: Males
Zeitfenster: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of BMI changes during the study.
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
BMI (kg/m^2) During the Study: Females
Zeitfenster: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of BMI changes during the study. Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in BMI: Females
Zeitfenster: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of BMI changes during the study.
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Age (Years) During the Study: Males
Zeitfenster: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of age during the study. Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Age: Males
Zeitfenster: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of age during the study.
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Age (Years) During the Study: Females
Zeitfenster: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of age during the study. Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Age: Females
Zeitfenster: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of age during the study.
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Flow-Mediated Dilatation (FMD) During the Study
Zeitfenster: Baseline, Months 6, 12, 18, 24, 30 and 36/ET
Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. Change from baseline was also determined.
Baseline, Months 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in FMD
Zeitfenster: Months 6, 12, 18, 24, 30 and 36/ET
Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100.
Months 6, 12, 18, 24, 30 and 36/ET

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator
Zeitfenster: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination)
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination)
Percentage of Participants by Study Drug Compliance Category
Zeitfenster: Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination)
Compliance to study drug was categorized as <80%, 80% - 120%, and greater than (>) 120%.
Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2009

Primärer Abschluss (Tatsächlich)

1. Oktober 2013

Studienabschluss (Tatsächlich)

1. Oktober 2013

Studienanmeldedaten

Zuerst eingereicht

21. Januar 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Januar 2009

Zuerst gepostet (Schätzen)

23. Januar 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. Februar 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. Februar 2021

Zuletzt verifiziert

1. Februar 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • A2581173
  • 2008-006130-95 (EudraCT-Nummer)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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