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Atorvastatin Three Year Pediatric Study

2021年2月17日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

272

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Arizona
      • Phoenix、Arizona、アメリカ、85016
        • Phoenix Children's Hospital
    • District of Columbia
      • Washington、District of Columbia、アメリカ、20010
        • Children's National Medical Center
    • Florida
      • Gainesville、Florida、アメリカ、32608
        • University of Florida
    • Maryland
      • Baltimore、Maryland、アメリカ、21287
        • Johns Hopkins University
      • Baltimore、Maryland、アメリカ、21287
        • Johns Hopkins
    • Ohio
      • Cincinnati、Ohio、アメリカ、45212
        • Medpace Clinical Pharmacology Unit
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19104
        • The Children's Hospital of Philadelphia
  • イタリア
      • Palermo、イタリア、90127
        • Dipartimento di Medicina Clinica e delle Patologie Emergenti-University Hospital of Palermo
      • Roma、イタリア、00161
        • Dipartimento di Clinica e Terapia Medica, Università degli Studi di Roma La Sapienza
  • カナダ
      • Quebec、カナダ、G1V 4M6
        • Clinique des Maladies Lipidiques de Québec
    • Quebec
      • Sainte-Foy,、Quebec、カナダ、G1V 4M6
        • Clinique des Maladies Lipidiques de Quebec Inc
  • ギリシャ
      • Athens、ギリシャ、115 27
        • 1st Pediatrics Clinic , University of Athens, Agia Sofia Hospital
  • スイス
      • Ch-3010 Bern、スイス
        • Dr. med. Jean-Marc Nuoffer
  • スペイン
      • Barcelona、スペイン、08041
        • Hospital Santa Creu i Sant Pau
      • Esplugues de Llobregat、スペイン、08950
        • Hospital Sant Joan de Deu
    • Alicante
      • Elche、Alicante、スペイン、03202
        • Hospital General Universitario de Elche
    • Badajoz
      • Merida、Badajoz、スペイン、6800
        • Hospital de Mérida
    • Cantabria
      • Santander、Cantabria、スペイン、39008
        • Hospital Universitario Marqués de Valdecilla
  • スロバキア
      • Bratislava、スロバキア、833 40
        • Metabolicka ambulancia, 2. Detská klinika Lekárskej fakulty Univerzity Komenského
      • Kosice、スロバキア、040 01
        • Detska fakultna nemocnica Kosice-old
      • Kosice、スロバキア、040 11
        • Detska Fakultna nemocnica Kosice
      • Poprad、スロバキア、05801
        • Lipmet, s.r.o.
      • Trencin、スロバキア、911 71
        • Fakultna nemocnica Trencin
  • ドイツ
      • Berlin、ドイツ、13353
        • Charité Campus Virchow-Klinikum
      • Freiburg、ドイツ、79098
        • Augenaerztliche Gemeinschaftspraxis
  • ノルウェー
      • Oslo、ノルウェー、0027
        • Rikshospitalet Lipidklinikken
  • ハンガリー
      • Budapest、ハンガリー、H-1094
        • Semmelweis Medical University
      • Szekesfehervar、ハンガリー、8003
        • Fejer Megyei Szent Gyorgy Korhaz
  • プエルトリコ
      • San German、プエルトリコ、683
        • Hospital de la Concepcion
  • ベルギー
      • Bruxelles、ベルギー、1200
        • Cliniques Universitaires Saint-Luc / Pediatrie generale
      • Leuven、ベルギー、3000
        • Universitaire Ziekenhuizen Leuven / Center for Metabolic Diseases
  • ポーランド
      • Bydgoszcz、ポーランド、85-667
        • Poradnia Chorob Metabolicznych
      • Warszawa、ポーランド、04-730
        • Klinika Chorob Metabolicznych
  • ロシア連邦
      • Moscow、ロシア連邦、119049
        • Moscow State Healthcare Institution 'Morozovskaya Children's City Clinical Hospital'
      • Saint-Petersburg、ロシア連邦、194100
        • Saint-Petersburg State Pediatric Medical Academy
      • Saint-Petersburg、ロシア連邦、196084
        • Saint-Petersburg State Healthcare Institution "Children's Polyclinic #35"
      • St Petersburg、ロシア連邦、194044
        • Autonomous Non-Profit Organization Medical Center 21 Century
  • 七面鳥
      • Ankara、七面鳥、06100
        • Hacettepe University Medical Faculty. Department of Pediatrics. Nutrition and Metabolism Unit
      • Ankara、七面鳥、6500
        • Gazi University, Medical Faculty
      • Izmir、七面鳥、35100
        • Ege University Medical Faculty

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

6年～15年 (子)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Atorvastatin
All subjects will be treated with atorvastatin
薬：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)

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

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

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2009年3月1日

一次修了 (実際)

2013年10月1日

研究の完了 (実際)

2013年10月1日

試験登録日

最初に提出

2009年1月21日

QC基準を満たした最初の提出物

2009年1月22日

最初の投稿 (見積もり)

2009年1月23日

学習記録の更新

投稿された最後の更新 (実際)

2021年2月21日

QC基準を満たした最後の更新が送信されました

2021年2月17日

最終確認日

2021年2月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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