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Atorvastatin Three Year Pediatric Study

17. února 2021 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

272

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

6 let až 15 let (Dítě)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Atorvastatin
All subjects will be treated with atorvastatin
Lék: 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)

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator
Časové okno: 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
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. března 2009

Primární dokončení (Aktuální)

1. října 2013

Dokončení studie (Aktuální)

1. října 2013

Termíny zápisu do studia

První předloženo

21. ledna 2009

První předloženo, které splnilo kritéria kontroly kvality

22. ledna 2009

První zveřejněno (Odhad)

23. ledna 2009

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. února 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. února 2021

Naposledy ověřeno

1. února 2021

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

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3
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