299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-002968-40-PL (EUCTR) | 31/10/2018 | 29/06/2018 | A Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in subjects with cistic fibrosis | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation - Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects | 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Belgium;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | ||
| 2 | EUCTR2016-004479-35-PL (EUCTR) | 26/09/2018 | 17/05/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation - A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic F | 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Belgium;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | ||
| 3 | EUCTR2016-004479-35-FR (EUCTR) | 08/08/2018 | 04/06/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | ||
| 4 | EUCTR2017-002968-40-DK (EUCTR) | 28/06/2018 | 24/06/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Australia;Denmark;Germany;United Kingdom;Switzerland | ||
| 5 | EUCTR2017-002968-40-GB (EUCTR) | 28/06/2018 | 07/03/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;Switzerland;United Kingdom | ||
| 6 | EUCTR2016-004479-35-BE (EUCTR) | 26/06/2018 | 30/03/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | ||
| 7 | EUCTR2016-004479-35-DE (EUCTR) | 26/06/2018 | 06/04/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | ||
| 8 | EUCTR2017-002968-40-BE (EUCTR) | 26/06/2018 | 30/03/2018 | A study lasting 220 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;Switzerland;United Kingdom | ||
| 9 | EUCTR2017-002968-40-IE (EUCTR) | 27/04/2018 | 08/03/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | ||
| 10 | EUCTR2016-004479-35-GB (EUCTR) | 24/04/2018 | 26/04/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | France;Poland;Belgium;Ireland;Denmark;Australia;Germany;Switzerland;United Kingdom | ||
| 11 | EUCTR2016-004479-35-DK (EUCTR) | 18/04/2018 | 22/02/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Poland;Belgium;Ireland;Australia;Denmark;Germany;United Kingdom;Switzerland | ||
| 12 | NCT02953314 (ClinicalTrials.gov) | November 2016 | 18/10/2016 | A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF) | A Phase 3, Open Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661 in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | Cystic Fibrosis | Drug: TEZ;Drug: TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 6 Years | 11 Years | All | 83 | Phase 3 | United States;Canada |
| 13 | EUCTR2014-004838-25-DE (EUCTR) | 16/08/2016 | 17/05/2016 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive | 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 155 | Phase 3 | United States;France;Canada;Belgium;Ireland;Austria;Germany;United Kingdom;Italy | ||
| 14 | NCT03486236 (ClinicalTrials.gov) | July 20, 2016 | 27/3/2018 | A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects | A Phase 1, Randomized, Double Blind, Placebo Controlled, Multiple Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With VX-661/Ivacaftor in Healthy Adult Subjects | Cystic Fibrosis | Drug: VX-440;Drug: TEZ;Drug: IVA;Drug: Matched Placebos | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 55 Years | All | 16 | Phase 1 | United Kingdom |
| 15 | EUCTR2014-004788-18-BE (EUCTR) | 03/06/2016 | 03/03/2016 | A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function | Cystic Fibrosis 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: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 16 | EUCTR2014-004838-25-AT (EUCTR) | 02/06/2016 | 20/04/2016 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive | 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 155 | Phase 3 | France;United States;Canada;Belgium;Ireland;Austria;Germany;Italy;United Kingdom | ||
| 17 | EUCTR2014-004827-29-DE (EUCTR) | 24/02/2016 | 21/09/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1375 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 18 | NCT02508207 (ClinicalTrials.gov) | February 2016 | 23/7/2015 | A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | A Phase 2, Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Exploratory Study to Evaluate Effects of VX-661 in Combination With Ivacaftor on Lung and Extrapulmonary Systems in Subjects Aged 18 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: Tezacaftor/Ivacaftor;Drug: Ivacaftor;Drug: Tezacaftor/Ivacaftor matching placebo;Drug: Ivacaftor matching placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 34 | Phase 2 | United States |
| 19 | EUCTR2014-004827-29-ES (EUCTR) | 12/01/2016 | 18/11/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | Cystic Fibrosis 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: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1375 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 20 | EUCTR2014-004837-13-DE (EUCTR) | 15/12/2015 | 21/04/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 19.0;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: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 21 | EUCTR2014-004827-29-SE (EUCTR) | 09/12/2015 | 27/08/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1375 | Phase 3 | United States;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden | ||
| 22 | EUCTR2014-004827-29-DK (EUCTR) | 30/11/2015 | 11/09/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1375 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 23 | EUCTR2014-004827-29-AT (EUCTR) | 27/11/2015 | 27/08/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1375 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 24 | EUCTR2014-004827-29-GB (EUCTR) | 03/11/2015 | 05/08/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older 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] - Respiratory Tract Diseases [C08] | Trade Name: Symkevi Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1375 | Phase 3 | United States;United Kingdom;Switzerland;Spain;Canada;Austria;Netherlands;Sweden;Belgium;Ireland;Denmark;Italy;Israel;Australia;France;Germany | ||
| 25 | EUCTR2014-004827-29-NL (EUCTR) | 03/11/2015 | 21/09/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1375 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 26 | EUCTR2014-004787-37-ES (EUCTR) | 26/10/2015 | 25/08/2015 | A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs. | A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR) | Cystic Fibrosis 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: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Canada;Spain;Austria;Australia;Israel;Germany | ||
| 27 | EUCTR2014-004827-29-BE (EUCTR) | 21/10/2015 | 06/08/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1375 | Phase 3 | United States;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden | ||
| 28 | EUCTR2014-004827-29-IE (EUCTR) | 19/10/2015 | 09/07/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1375 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 29 | EUCTR2014-004787-37-DE (EUCTR) | 24/09/2015 | 19/06/2015 | A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs. | A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR) | Cystic Fibrosis MedDRA version: 19.0;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: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Canada;Spain;Austria;Australia;Israel;Germany | ||
| 30 | EUCTR2014-004787-37-AT (EUCTR) | 21/09/2015 | 18/06/2015 | A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs. | A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR) | Cystic Fibrosis MedDRA version: 19.0;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: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Canada;Spain;Australia;Austria;Israel;Germany | ||
| 31 | EUCTR2014-004827-29-IT (EUCTR) | 01/09/2015 | 08/07/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | Cystic Fibrosis 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: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1375 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 32 | EUCTR2014-004838-25-BE (EUCTR) | 31/07/2015 | 26/05/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive | Cystic Fibrosis 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: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Canada;Belgium;Ireland;Austria;Germany;Italy;United Kingdom | ||
| 33 | EUCTR2014-004788-18-DE (EUCTR) | 24/07/2015 | 31/03/2015 | A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function | Cystic Fibrosis MedDRA version: 19.0;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: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 34 | EUCTR2014-004837-13-IT (EUCTR) | 22/07/2015 | 27/03/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis 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: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 35 | EUCTR2014-004788-18-IT (EUCTR) | 15/07/2015 | 19/03/2015 | A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function | Cystic Fibrosis 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: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 36 | EUCTR2014-004788-18-NL (EUCTR) | 10/07/2015 | 08/04/2015 | A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function | Cystic Fibrosis MedDRA version: 19.0;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: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | France;United States;Canada;Belgium;Australia;Israel;Germany;Netherlands;Italy;United Kingdom | ||
| 37 | EUCTR2014-004837-13-NL (EUCTR) | 10/07/2015 | 08/04/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis 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: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | France;United States;Canada;Spain;Ireland;Denmark;Germany;Netherlands;Italy;United Kingdom;Switzerland;Sweden | ||
| 38 | EUCTR2014-004837-13-ES (EUCTR) | 02/07/2015 | 15/06/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis 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: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | United States;France;Canada;Spain;Ireland;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 39 | EUCTR2014-004837-13-DK (EUCTR) | 24/06/2015 | 26/03/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis 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: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 40 | EUCTR2014-004838-25-IE (EUCTR) | 22/06/2015 | 10/04/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive | 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 155 | Phase 3 | France;United States;Canada;Belgium;Ireland;Austria;Germany;Italy;United Kingdom | ||
| 41 | EUCTR2014-004837-13-IE (EUCTR) | 11/06/2015 | 05/03/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 19.0;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: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 42 | EUCTR2014-004788-18-GB (EUCTR) | 08/06/2015 | 08/04/2015 | A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function | Cystic Fibrosis MedDRA version: 19.0;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: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 204 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;Switzerland;United Kingdom | ||
| 43 | EUCTR2014-004838-25-IT (EUCTR) | 20/05/2015 | 30/03/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive | Cystic Fibrosis 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: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Belgium;Ireland;Austria;Germany;United Kingdom;Italy | ||
| 44 | EUCTR2014-004837-13-GB (EUCTR) | 12/05/2015 | 20/03/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis 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: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 490 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;Switzerland;United Kingdom;Sweden | ||
| 45 | EUCTR2014-004837-13-SE (EUCTR) | 24/04/2015 | 06/03/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis 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: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | United States;France;Canada;Spain;Ireland;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 46 | NCT02392234 (ClinicalTrials.gov) | March 2015 | 12/3/2015 | A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function | Cystic Fibrosis | Drug: VX-661/Ivacaftor;Drug: Ivacaftor;Drug: Placebo matched to VX-661/ ivacaftor;Drug: Placebo matched to Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 248 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Switzerland;United Kingdom |
| 47 | EUCTR2011-003821-93-DE (EUCTR) | 13/03/2013 | 23/12/2011 | A Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | A Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | Cystic Fibrosis 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] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-661 Product Code: VX-661, VRT-893661 INN or Proposed INN: Not yet assigned Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Product Name: VX-661 Product Code: VX-661, VRT-893661 INN or Proposed INN: Not yet assigned Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;Canada;Germany;United Kingdom | ||
| 48 | EUCTR2011-003821-93-GB (EUCTR) | 01/05/2012 | 19/04/2012 | A Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | A Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | Cystic Fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-661 Product Code: VX-661, VRT-893661 INN or Proposed INN: Not yet assigned Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Product Name: VX-661 Product Code: VX-661, VRT-893661 INN or Proposed INN: Not yet assigned Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Germany;United Kingdom | ||
| 49 | NCT01531673 (ClinicalTrials.gov) | February 2012 | 1/2/2012 | Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) Mutation | A Phase 2, Multicenter, Double-Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: VX-661;Drug: Ivacaftor;Drug: Placebo matched to VX-661;Drug: Placebo matched to ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 194 | Phase 2 | United States;Canada;Germany;United Kingdom |
| 50 | EUCTR2016-004479-35-IE (EUCTR) | 19/02/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | |||
| 51 | EUCTR2017-002968-40-DE (EUCTR) | 05/04/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, 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] - Respiratory Tract Diseases [C08] | Trade Name: Symdeko Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symdeko Product Name: Ivacaftor 75 mg Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor 150 mg Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | |||
| 52 | EUCTR2017-002968-40-FR (EUCTR) | 13/06/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, 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] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 121 | Phase 3 | United States;France;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland |