VRT-826809 ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
299Cystic fibrosis7

299. Cystic fibrosis


Clinical trials : 1,696 Drugs : 1,644 - (DrugBank : 272) / Drug target genes : 96 - Drug target pathways : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-020413-90-IE
(EUCTR)
08/01/201413/12/2013Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-809
Product Code: VX-809, VRT-826809
INN or Proposed INN: lumacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Lumacaftor/Ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: Lumacaftor
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Belgium;Ireland;Australia;Germany;United Kingdom
2EUCTR2010-020413-90-GB
(EUCTR)
06/01/201410/12/2013Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-809
Product Code: VX-809, VRT-826809
INN or Proposed INN: lumacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Lumacaftor/Ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Belgium;Ireland;Australia;Germany;United Kingdom
3EUCTR2010-020413-90-BE
(EUCTR)
08/02/201115/10/2010Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-809
Product Code: VX-809, VRT-826809
INN or Proposed INN: lumacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Lumacaftor/Ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: Lumacaftor
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
293Phase 2United States;Belgium;Ireland;Australia;Germany;United Kingdom;New Zealand
4EUCTR2010-020413-90-DE
(EUCTR)
06/01/201115/10/2010Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-809
Product Code: VX-809, VRT-826809
INN or Proposed INN: lumacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Lumacaftor/Ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: Lumacaftor
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
293Phase 2New Zealand;United Kingdom;Germany;Australia;Belgium;United States
5EUCTR2008-006446-25-NL
(EUCTR)
26/08/200910/03/2009A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101 Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
MedDRA version: 9.1;Classification code 10011764;Term: Cystic fibrosis NOS
Product Name: VX-809
Product Code: VX-809
Other descriptive name: VRT-826809
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
90Germany;Netherlands;Belgium
6EUCTR2008-006446-25-BE
(EUCTR)
08/07/200912/05/2009A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101 Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
MedDRA version: 9.1;Classification code 10011764;Term: Cystic fibrosis NOS
Product Name: VX-809
Product Code: VX-809
Other descriptive name: VRT-826809
Product Name: VX-809
Product Code: VX-809
Other descriptive name: VRT-826809
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
90Germany;Netherlands;Belgium
7EUCTR2008-006446-25-DE
(EUCTR)
14/05/200914/04/2009A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101 Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
MedDRA version: 9.1;Classification code 10011764;Term: Cystic fibrosis NOS
Product Name: VX-809
Product Code: VX-809
Other descriptive name: VRT-826809
Product Name: VX-809
Product Code: VX-809
Other descriptive name: VRT-826809
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
90Belgium;Netherlands;Germany