TAMOX ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
113筋ジストロフィー7

113. 筋ジストロフィー


臨床試験数 : 646 薬物数 : 471 - (DrugBank : 105) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
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agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2017-004554-42-FR
(EUCTR)
26/03/202017/08/2018The study examines boys suffering from Duchenne muscular dystrophy. We are carrying out this study to examine the effect and tolerance of Tamoxifen in this disease.Tamoxifen in Duchenne muscular dystrophy - TAMDMDA multicentre, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy 48-week trial Duchenne muscular dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Tamoxifen 20mg Hexal® Filmtabletten
INN or Proposed INN: Tamoxifen
Other descriptive name: TAMOXIFEN CITRATE
University of Basel Children's Hospital, Division of NeuropediatricsNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
100Phase 3France;Belgium;Spain;Turkey;Netherlands;Germany;United Kingdom;Switzerland
2EUCTR2017-004554-42-GB
(EUCTR)
29/01/201903/08/2018The study examines boys suffering from Duchenne muscular dystrophy. We are carrying out this study to examine the effect and tolerance of Tamoxifen in this disease.Tamoxifen in Duchenne muscular dystrophy - TAMDMDA multicentre, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy 48-week trialTamoxifen in Duchenne muscular dystrophy: A 48-week open labelextension of a multicentre, randomised, double-blind, placebo-controlled,phase 3 safety and efficacy trial Duchenne muscular dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Tamoxifen 20mg Hexal® Filmtabletten
INN or Proposed INN: Tamoxifen
Other descriptive name: TAMOXIFEN CITRATE
University of Basel Children's Hospital, Division of NeuropediatricsNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
100Phase 3France;Belgium;Spain;Netherlands;Germany;Switzerland;United Kingdom
3EUCTR2017-004554-42-ES
(EUCTR)
22/01/201917/09/2018The study examines boys suffering from Duchenne muscular dystrophy. We are carrying out this study to examine the effect and tolerance of Tamoxifen in this disease. Tamoxifen in Duchenne muscular dystrophy - TAMDMD A multicentre, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy 48-week trial Duchenne muscular dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: TAMOX
INN or Proposed INN: Tamoxifen
Other descriptive name: TAMOXIFEN CITRATE
University of Basel Children's Hospital, Division of NeuropediatricsNULLAuthorised-recruitment may be ongoing or finished Female: no
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Belgium;Spain;Turkey;Netherlands;Germany;United Kingdom;Switzerland
4EUCTR2017-004554-42-NL
(EUCTR)
16/01/201902/10/2018The study examines boys suffering from Duchenne muscular dystrophy. We are carrying out this study to examine the effect and tolerance of Tamoxifen in this disease.Tamoxifen in Duchenne muscular dystrophy - TAMDMDA multicentre, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy 48-week trial Duchenne muscular dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: TAMOXIFEN
INN or Proposed INN: Tamoxifen
Other descriptive name: TAMOXIFEN CITRATE
University of Basel Children's Hospital, Division of NeuropediatricsNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
100Phase 3France;Belgium;Spain;Turkey;Germany;Netherlands;United Kingdom;Switzerland
5NCT03354039
(ClinicalTrials.gov)
June 12, 201810/10/2017Tamoxifen in Duchenne Muscular DystrophyTamoxifen in Duchenne Muscular Dystrophy: A Multicenter, Randomised, Double-blind, Placebo-controlled, Phase 3 Safety and Efficacy 48-week TrialDuchenne Muscular DystrophyDrug: Tamoxifen;Drug: Matching placeboUniversity Hospital, Basel, SwitzerlandNULLCompleted78 Months16 YearsMale93Phase 3France;Germany;Netherlands;Spain;Switzerland;United Kingdom
6EUCTR2017-004554-42-BE
(EUCTR)
30/04/2019The study examines boys suffering from Duchenne muscular dystrophy. We are carrying out this study to examine the effect and tolerance of Tamoxifen in this disease.Tamoxifen in Duchenne muscular dystrophy:A multicenter, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy 48-week trialTamoxifen in Duchenne muscular dystrophy: A 48-week open label extension of a multicentre, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy trial Duchenne muscular dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Tamoxifen 20mg Hexal® Filmtabletten
INN or Proposed INN: Tamoxifen
Other descriptive name: TAMOXIFEN CITRATE
University of Basel Children's Hospital, Division of NeuropediatricsNULLNAFemale: no
Male: yes
100Phase 3France;Spain;Belgium;Turkey;Netherlands;Germany;United Kingdom;Switzerland
7EUCTR2017-004554-42-DE
(EUCTR)
27/07/2018The study examines boys suffering from Duchenne muscular dystrophy. We are carrying out this study to examine the effect and tolerance of Tamoxifen in this disease. Tamoxifen in Duchenne muscular dystrophy: A multicenter, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy 48-week trial Tamoxifen in Duchenne muscular dystrophy: A 48-week open label extension of a multicentre, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy trial Duchenne muscular dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Tamoxifen 20mg Hexal® Filmtabletten
INN or Proposed INN: Tamoxifen
Other descriptive name: TAMOXIFEN CITRATE
University of Basel Children's Hospital, Division of NeuropediatricsNULLNA Female: no
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Belgium;Spain;Turkey;Netherlands;Germany;United Kingdom;Switzerland