EMD 87580 ( 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4

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
Secondary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2015-002530-50-IT
(EUCTR)
19/01/201722/08/2018A phase Ib, open label study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending oral doses of rimeporide in patients with Duchenne Muscular Dystrophy (DMD)A phase Ib, open label study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending oral doses of rimeporide in patients with Duchenne Muscular Dystrophy (DMD) - RIM4DMD Distrofia Muscolare di Duchenne (DMD)
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] - Musculoskeletal Diseases [C05]
Product Name: rimeporide
Product Code: EMD 87580
ESPERARE FOUNDATIONNULLNot Recruiting Female: no
Male: yes
20 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Spain;United Kingdom;Italy
2EUCTR2015-002530-50-FR
(EUCTR)
18/12/201511/09/2015Rimeporide in patients with Duchenne Muscular DystrophyA phase Ib, open label study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending oral doses of Rimeporide in patients with Duchenne Muscular Dystrophy. Duchenne Muscular Dystrophy (DMD)
MedDRA version: 18.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Rimeporide
Product Code: EMD 87580
INN or Proposed INN: N-(4,5-Bis methanesulfonyl-2-methyl-benzoyl)guanidine hydrochloride monohydrate
Other descriptive name: Rimeporide
INN or Proposed INN: N-(4,5-Bis methanesulfonyl-2-methyl-benzoyl)guanidine hydrochloride monohydrate
Other descriptive name: Rimeporide
EspeRareNULLNot RecruitingFemale: no
Male: yes
20Phase 1France;Spain;Italy;United Kingdom;Switzerland
3EUCTR2015-002530-50-ES
(EUCTR)
04/11/201525/08/2015Rimeporide in patients with Duchenne Muscular DystrophyA phase Ib, open label study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending oral doses of Rimeporide in patients with Duchenne Muscular Dystrophy. - Rim4DMD Duchenne Muscular Dystrophy (DMD)
MedDRA version: 18.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Rimeporide
Product Code: EMD 87580
INN or Proposed INN: N(4,5Bis methanesulfonyl2methylbenzoyl) guanidine hydrochloride monohydrate
Other descriptive name: Rimeporide
EspeRareNULLNot RecruitingFemale: no
Male: yes
20Phase 1France;Spain;Italy;United Kingdom;Switzerland
4EUCTR2015-002530-50-GB
(EUCTR)
29/10/201507/09/2015Rimeporide in patients with Duchenne Muscular DystrophyA phase Ib, open label study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending oral doses of Rimeporide in patients with Duchenne Muscular Dystrophy - RIM4DMD Duchenne Muscular Dystrophy (DMD)
MedDRA version: 18.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Rimeporide
Product Code: EMD 87580
INN or Proposed INN: N-(4,5-Bis methanesulfonyl-2-methyl-benzoyl)guanidine hydrochloride monohydrate
Other descriptive name: Rimeporide
INN or Proposed INN: N-(4,5-Bis methanesulfonyl-2-methyl-benzoyl)guanidine hydrochloride monohydrate
Other descriptive name: Rimeporide
EspeRareNULLNot RecruitingFemale: no
Male: yes
20Phase 1France;Spain;Italy;Switzerland;United Kingdom