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Atorvastatin Three Year Pediatric Study

2021년 2월 17일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

272

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

6년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Atorvastatin
All subjects will be treated with atorvastatin
의약품: 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)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 3월 1일

기본 완료 (실제)

2013년 10월 1일

연구 완료 (실제)

2013년 10월 1일

연구 등록 날짜

최초 제출

2009년 1월 21일

QC 기준을 충족하는 최초 제출

2009년 1월 22일

처음 게시됨 (추정)

2009년 1월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 2월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 2월 17일

마지막으로 확인됨

2021년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

atorvastatin에 대한 임상 시험

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