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 | NCT04235140 (ClinicalTrials.gov) | February 24, 2020 | 15/1/2020 | Long-term Safety of Lumacaftor/Ivacaftor in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation | A Phase 3, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumacaftor/Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation | Cystic Fibrosis | Drug: LUM/IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 12 Months | N/A | All | 52 | Phase 3 | United States;Canada |
| 2 | NCT03601637 (ClinicalTrials.gov) | September 7, 2018 | 18/7/2018 | Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del | A Phase 3, 2-part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del | Cystic Fibrosis | Drug: LUM;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Months | 23 Months | All | 61 | Phase 3 | United States;Canada |
| 3 | NCT03625466 (ClinicalTrials.gov) | August 10, 2018 | 7/8/2018 | A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | An Exploratory Phase 2, 2-part, Randomized, Double-blind, Placebo-controlled Study With a Long-term, Open-label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | Cystic Fibrosis | Drug: LUM;Drug: IVA;Drug: Matched Placebos | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 2 Years | 5 Years | All | 51 | Phase 2 | Germany |
| 4 | EUCTR2017-003761-99-DE (EUCTR) | 27/06/2018 | 19/02/2018 | A Study of the Effects of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | An Exploratory Phase 2, 2-part, Randomized, Double blind, Placebo controlled Study With a Long term, Open label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | 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: lumacaftor / ivacaftor Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Product Name: lumacaftor / ivacaftor Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Orkambi 100 mg/125 mg film-coated tablets Product Name: LUM/IVA fixed-dose combination INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Other descriptive name: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Germany | ||
| 5 | NCT03150719 (ClinicalTrials.gov) | May 24, 2017 | 3/5/2017 | A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF) | Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del CFTR Mutation | Cystic Fibrosis | Drug: Tezacaftor/Ivacaftor;Drug: Ivacaftor;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 98 | Phase 3 | United States;France;Germany |
| 6 | NCT03125395 (ClinicalTrials.gov) | May 12, 2017 | 19/4/2017 | A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | A Phase 3, Rollover Study to Evaluate the Safety of Long-term Treatment With Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: LUM/IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 2 Years | N/A | All | 57 | Phase 3 | United States;Canada |
| 7 | EUCTR2016-004996-33-ES (EUCTR) | 03/05/2017 | 10/03/2017 | A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del-CFTR Mutation | A Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallelgroup, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del-CFTR Mutation | Cystic fibrosis subjects Homozygous for the F508del-CFTR Mutation MedDRA version: 19.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Orkambi Product Name: Orkambi INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Other descriptive name: IVACAFTOR | Vertex Pharmaceuticals Incoporated | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 4 | United States;Canada;Spain;Australia;United Kingdom | ||
| 8 | NCT03061331 (ClinicalTrials.gov) | January 31, 2017 | 9/2/2017 | Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR Mutation | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation | Cystic Fibrosis | Drug: LUM/IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 20 | Phase 2 | Netherlands |
| 9 | EUCTR2015-004841-13-CZ (EUCTR) | 04/01/2017 | 10/08/2016 | A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi | 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 Code: VX-371 in hypertonic saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Ivacaftor INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic saline INN or Proposed INN: 4.2% NaCl/inhalation solution | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | France;United States;Czech Republic;Ireland;United Kingdom | ||
| 10 | NCT04623879 (ClinicalTrials.gov) | December 29, 2016 | 12/10/2020 | Real Life Evaluation of the Multi-organ Effects of Lumacaftor/Ivacaftor on F508del Homozygous Cystic Fibrosis Patients. | Real Life Evaluation of the Multi-organ Effects of Lumacaftor/Ivacaftor on F508del Homozygous Cystic Fibrosis Patients. | Cystic Fibrosis | Drug: Lumacaftor, Ivacaftor Drug Combination | Carmel Medical Center | NULL | Completed | 18 Years | 99 Years | All | 13 | NULL | |
| 11 | EUCTR2016-001585-29-NL (EUCTR) | 21/12/2016 | 18/07/2016 | Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-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: Orkambi 200 mg/125 mg film-coated tablets Product Name: LUM/IVA fixed-dose combination INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Netherlands | ||
| 12 | NCT02875366 (ClinicalTrials.gov) | September 2016 | 15/8/2016 | A Study of the Effects of Lumacaftor/Ivacaftor (LUM/IVA) on Exercise Tolerance in Subjects With Cystic Fibrosis (CF), Homozygous for the F508del-CFTR Mutation | A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study of the Effect of Lumacaftor/Ivacaftor Combination Therapy on Exercise Tolerance in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: LUM/IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 70 | Phase 4 | Australia;United Kingdom |
| 13 | EUCTR2015-004841-13-IE (EUCTR) | 08/08/2016 | 07/06/2016 | A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi | 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 Code: VX-371 in hypertonic saline INN or Proposed INN: not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic Saline INN or Proposed INN: 4.2% NaCl/Inhalation solution | Vertex Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | France;United States;Czech Republic;Ireland;United Kingdom | ||
| 14 | EUCTR2015-004841-13-GB (EUCTR) | 20/07/2016 | 09/06/2016 | A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi | 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 Code: VX-371 in hypertonic saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic saline INN or Proposed INN: 4.2% NaCl/Inhalation solution | Vertex Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Czech Republic;Ireland;United Kingdom | ||
| 15 | EUCTR2016-000066-34-GB (EUCTR) | 24/06/2016 | 25/07/2017 | A Study of the Effects of Lumacaftor/Ivacaftor on Exercise Tolerance in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study of the Effect of Lumacaftor/Ivacaftor Combination Therapy on Exercise Tolerance 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] | Trade Name: Orkambi Product Name: lumacaftor/ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: lumacaftor Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 66 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Australia;United Kingdom | ||
| 16 | NCT02823470 (ClinicalTrials.gov) | June 2016 | 1/7/2016 | A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR Mutation | A Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallel-group, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del CFTR Mutation | Cystic Fibrosis | Drug: LUM/IVA;Device: activated smart device;Device: de-activated smart device | Vertex Pharmaceuticals Incorporated | NULL | Terminated | 16 Years | N/A | All | 24 | Phase 4 | United States;Canada |
| 17 | EUCTR2015-001644-11-DE (EUCTR) | 25/05/2016 | 31/03/2016 | Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor. | A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-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: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: lumacaftor Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: Lumacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 256 | Phase 3 | United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | ||
| 18 | NCT02797132 (ClinicalTrials.gov) | May 2016 | 25/5/2016 | Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | A Phase 3, 2-Part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: LUM/IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 2 Years | 5 Years | All | 62 | Phase 3 | United States;Canada |
| 19 | EUCTR2015-001644-11-BE (EUCTR) | 06/04/2016 | 08/01/2016 | Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor. | A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-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: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: lumacaftor Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: Lumacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 256 | Phase 3 | United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | ||
| 20 | EUCTR2015-001644-11-FR (EUCTR) | 16/03/2016 | 20/04/2016 | Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor. | A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-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: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: lumacaftor Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: Lumacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 256 | Phase 3 | United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | ||
| 21 | EUCTR2015-001644-11-DK (EUCTR) | 15/03/2016 | 08/02/2016 | Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor. | A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-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: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: lumacaftor Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: Lumacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 256 | Phase 3 | United States;France;Canada;Belgium;Australia;Denmark;Germany;United Kingdom;Sweden | ||
| 22 | EUCTR2015-001644-11-GB (EUCTR) | 22/01/2016 | 10/11/2015 | Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor. | A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-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: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: lumacaftor Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: Lumacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 256 | Phase 3 | United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | ||
| 23 | NCT02589236 (ClinicalTrials.gov) | November 2015 | 26/10/2015 | Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of N91115 to Evaluate Efficacy and Safety in Patients With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation Treated With Lumacaftor/Ivacaftor | Cystic Fibrosis | Drug: Cavosonstat;Drug: Placebo | Nivalis Therapeutics, Inc. | Medidata Solutions | Completed | 18 Years | N/A | All | 138 | Phase 2 | United States |
| 24 | EUCTR2015-000543-16-DE (EUCTR) | 14/10/2015 | 18/05/2015 | A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | ||
| 25 | EUCTR2015-000543-16-BE (EUCTR) | 24/09/2015 | 08/06/2015 | A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | ||
| 26 | EUCTR2015-000543-16-DK (EUCTR) | 23/09/2015 | 22/05/2015 | A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Belgium;Australia;Denmark;Germany;United Kingdom;Sweden | ||
| 27 | EUCTR2015-000543-16-SE (EUCTR) | 19/08/2015 | 20/05/2015 | A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | ||
| 28 | EUCTR2015-000543-16-GB (EUCTR) | 19/06/2015 | 15/05/2015 | A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 200 | 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;Denmark;Australia;Germany;United Kingdom;Sweden | ||
| 29 | EUCTR2013-000604-41-DE (EUCTR) | 10/03/2014 | 20/09/2013 | A 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 drugs | A 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 30 | EUCTR2013-000604-41-NL (EUCTR) | 14/02/2014 | 26/09/2013 | A 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 drugs | A 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 31 | EUCTR2013-000604-41-IT (EUCTR) | 21/01/2014 | 14/08/2013 | A 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 drugs | A 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 32 | EUCTR2010-020413-90-IE (EUCTR) | 08/01/2014 | 13/12/2013 | Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation | A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-809 Product Code: VX-809, VRT-826809 INN or Proposed INN: lumacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Lumacaftor/Ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: Lumacaftor INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Belgium;Ireland;Australia;Germany;United Kingdom | ||
| 33 | EUCTR2010-020413-90-GB (EUCTR) | 06/01/2014 | 10/12/2013 | Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation | A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-809 Product Code: VX-809, VRT-826809 INN or Proposed INN: lumacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Lumacaftor/Ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: Lumacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Belgium;Ireland;Australia;Germany;United Kingdom | ||
| 34 | EUCTR2013-000604-41-CZ (EUCTR) | 18/12/2013 | 13/09/2013 | A 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 drugs | A 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 35 | EUCTR2013-000604-41-SE (EUCTR) | 10/12/2013 | 13/09/2013 | A 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 drugs | A 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 36 | EUCTR2013-000604-41-IE (EUCTR) | 09/12/2013 | 10/10/2013 | A 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 drugs | A 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 37 | EUCTR2013-000604-41-BE (EUCTR) | 04/12/2013 | 17/09/2013 | A 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 drugs | A 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 38 | EUCTR2013-000604-41-ES (EUCTR) | 03/12/2013 | 08/10/2013 | A 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 drugs | A 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 39 | EUCTR2013-000604-41-DK (EUCTR) | 19/11/2013 | 19/11/2013 | A 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 drugs | A 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 40 | EUCTR2013-000604-41-AT (EUCTR) | 23/10/2013 | 16/09/2013 | A 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 drugs | A 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 41 | EUCTR2013-000604-41-GB (EUCTR) | 10/10/2013 | 17/09/2013 | A 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 drugs | A 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 42 | EUCTR2012-003990-24-AT (EUCTR) | 26/08/2013 | 03/04/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary 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 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | United States;France;Canada;Spain;Belgium;Denmark;Australia;Austria;Germany;United Kingdom | ||
| 43 | EUCTR2012-003989-40-NL (EUCTR) | 21/08/2013 | 17/05/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary 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 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 501 | Phase 3 | France;United States;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 44 | EUCTR2012-003990-24-ES (EUCTR) | 09/08/2013 | 16/05/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary 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 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | United States;France;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;United Kingdom | ||
| 45 | EUCTR2012-003990-24-DK (EUCTR) | 27/06/2013 | 17/05/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary 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 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | United States;France;Canada;Spain;Belgium;Austria;Australia;Denmark;Germany;United Kingdom | ||
| 46 | EUCTR2012-003989-40-CZ (EUCTR) | 26/06/2013 | 26/03/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary 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 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | United States;France;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 47 | EUCTR2012-003990-24-BE (EUCTR) | 25/06/2013 | 26/03/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary 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 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | United States;France;Canada;Spain;Belgium;Denmark;Austria;Australia;Germany;United Kingdom | ||
| 48 | EUCTR2012-003990-24-DE (EUCTR) | 20/06/2013 | 26/03/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary 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 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | United States;France;Canada;Spain;Belgium;Denmark;Austria;Australia;Germany;United Kingdom | ||
| 49 | EUCTR2012-003989-40-GB (EUCTR) | 10/06/2013 | 13/05/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary 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 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 Incorporated | NULL | Not 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): no | France;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 50 | EUCTR2012-003990-24-GB (EUCTR) | 10/06/2013 | 13/05/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary 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 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 Incorporated | NULL | Not 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): no | France;United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;United Kingdom | ||
| 51 | EUCTR2012-003989-40-IE (EUCTR) | 07/06/2013 | 11/04/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary 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 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | France;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 52 | EUCTR2012-003989-40-IT (EUCTR) | 22/05/2013 | 21/03/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary 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 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | France;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 53 | EUCTR2012-003989-40-DE (EUCTR) | 17/05/2013 | 26/03/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary 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 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | United States;France;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 54 | EUCTR2012-003989-40-SE (EUCTR) | 07/05/2013 | 18/03/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary 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 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | United States;France;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 55 | EUCTR2010-020413-90-BE (EUCTR) | 08/02/2011 | 15/10/2010 | Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation | A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-809 Product Code: VX-809, VRT-826809 INN or Proposed INN: lumacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Lumacaftor/Ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: Lumacaftor INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 293 | Phase 2 | United States;Belgium;Ireland;Australia;Germany;United Kingdom;New Zealand | ||
| 56 | EUCTR2010-020413-90-DE (EUCTR) | 06/01/2011 | 15/10/2010 | Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation | A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-809 Product Code: VX-809, VRT-826809 INN or Proposed INN: lumacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Lumacaftor/Ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: Lumacaftor INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 293 | Phase 2 | United States;Belgium;Australia;Germany;United Kingdom;New Zealand | ||
| 57 | EUCTR2015-000543-16-FR (EUCTR) | 07/07/2015 | A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | |||
| 58 | EUCTR2015-004841-13-FR (EUCTR) | 23/06/2016 | A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi | 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 Code: VX-371 in hypertonic saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Ivacaftor INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic saline INN or Proposed INN: 4.2% NaCl/inhalation solution | Vertex Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Czech Republic;Ireland;United Kingdom | |||
| 59 | EUCTR2017-001309-34-Outside-EU/EEA (EUCTR) | 29/03/2017 | Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease | A Phase 3b, Open-Label Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Cystic Fibrosis and Advanced Lung Disease, Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 19.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: lumacaftor/ivacaftor Product Name: lumacaftor/ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 46 | Phase 3 | United States | |||
| 60 | EUCTR2015-001644-11-SE (EUCTR) | 05/11/2015 | Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor. | A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-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: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: lumacaftor Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: Lumacaftor | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 256 | Phase 3 | France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | |||
| 61 | EUCTR2017-001078-41-Outside-EU/EEA (EUCTR) | 27/03/2017 | A study in people with cystic fibrosis (a rare pulmonary disease) to assess the pharmacokinetics and safety of a combination of two experimental drugs | A Phase 3, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: lumacaftor/ivacaftor Product Name: lumacaftor/ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 58 | Phase 3 | United States;Canada |