Lumacaftor/ivacaftor 200mg/83mg tablet ( DrugBank: Ivacaftor, Lumacaftor )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
299嚢胞性線維症24

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-000604-41-DE
(EUCTR)
10/03/201420/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
2EUCTR2013-000604-41-NL
(EUCTR)
14/02/201426/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
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] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
3EUCTR2013-000604-41-IT
(EUCTR)
21/01/201414/08/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
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] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
4EUCTR2013-000604-41-CZ
(EUCTR)
18/12/201313/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
5EUCTR2013-000604-41-SE
(EUCTR)
10/12/201313/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
6EUCTR2013-000604-41-IE
(EUCTR)
09/12/201310/10/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
7EUCTR2013-000604-41-BE
(EUCTR)
04/12/201317/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
8EUCTR2013-000604-41-ES
(EUCTR)
03/12/201308/10/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
9EUCTR2013-000604-41-DK
(EUCTR)
19/11/201319/11/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Sweden
10EUCTR2013-000604-41-AT
(EUCTR)
23/10/201316/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
11EUCTR2013-000604-41-GB
(EUCTR)
10/10/201317/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
12EUCTR2012-003990-24-AT
(EUCTR)
26/08/201303/04/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Canada;Spain;Belgium;Denmark;Australia;Austria;Germany;United Kingdom
13EUCTR2012-003989-40-NL
(EUCTR)
21/08/201317/05/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
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] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3France;United States;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden
14EUCTR2012-003990-24-ES
(EUCTR)
09/08/201316/05/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;United Kingdom
15EUCTR2012-003990-24-DK
(EUCTR)
27/06/201317/05/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
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] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Canada;Spain;Belgium;Austria;Australia;Denmark;Germany;United Kingdom
16EUCTR2012-003989-40-CZ
(EUCTR)
26/06/201326/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
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] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;United Kingdom;Italy;Sweden
17EUCTR2012-003990-24-BE
(EUCTR)
25/06/201326/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
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] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Canada;Spain;Belgium;Denmark;Austria;Australia;Germany;United Kingdom
18EUCTR2012-003990-24-DE
(EUCTR)
20/06/201326/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
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] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Canada;Spain;Belgium;Denmark;Austria;Australia;Germany;United Kingdom
19EUCTR2012-003989-40-GB
(EUCTR)
10/06/201313/05/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
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] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
501 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
20EUCTR2012-003990-24-GB
(EUCTR)
10/06/201313/05/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
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] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
501 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;United Kingdom
21EUCTR2012-003989-40-IE
(EUCTR)
07/06/201311/04/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
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] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3France;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
22EUCTR2012-003989-40-IT
(EUCTR)
22/05/201321/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3France;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
23EUCTR2012-003989-40-DE
(EUCTR)
17/05/201326/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
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] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
24EUCTR2012-003989-40-SE
(EUCTR)
07/05/201318/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
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] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;United Kingdom;Italy;Sweden