100 mg VX-445 /50 mg TEZ/75 mg IVA FDC ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
299Cystic fibrosis1

299. Cystic fibrosis


Clinical trials : 1,695 Drugs : 1,527 - (DrugBank : 268) / Drug target genes : 111 - Drug target pathways : 174
No.TrialIDDate_
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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agemax
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PhaseCountries
1EUCTR2018-004652-38-DE
(EUCTR)
24/06/2019A Study Evaluating the Long-term Safety of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy Cystic Fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100 mg VX-445 /50 mg TEZ/75 mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Trikafta
Product Name: 100 mg ELX (VX-445) / 50 mg TEZ / 75 mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
481Phase 3Switzerland;United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Germany;United Kingdom