- Trials with a EudraCT protocol (21)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
21 result(s) found for: lumacaftor ivacaftor AND vertex.
Displaying page 1 of 2.
EudraCT Number: 2019-002254-23 | Sponsor Protocol Number: VX15-809-014 | Start Date*: 2019-06-10 |
Sponsor Name:Vertex Pharmaceuticals Incorporated | ||
Full Title: A Phase 1, Randomized, Open-label Study to Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Lumacaftor in Combination With Ivacaftor in Healt... | ||
Medical condition: Healthy Adult Subjects | ||
Disease: | ||
Population Age: Adults | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2019-001314-41 | Sponsor Protocol Number: 69501 | Start Date*: 2019-05-06 |
Sponsor Name: | ||
Full Title: Kinetics of ivacaftor at Switch Orkambi Symkevi study | ||
Medical condition: Cystic fibrosis | ||
Disease: | ||
Population Age: Adults | Gender: Male, Female | |
Trial protocol: NL (Prematurely Ended) | ||
Trial results: (No results available) |
EudraCT Number: 2017-004794-13 | Sponsor Protocol Number: VX16-809-122 | Start Date*: 2020-05-01 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: 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 | |||||||||||||
Medical condition: | |||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2023-000946-41 | Sponsor Protocol Number: VX19-809-124 | Start Date*: 2023-10-17 |
Sponsor Name:Vertex Pharmaceuticals Incorporated | ||
Full Title: 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 ... | ||
Medical condition: Cystic Fibrosis | ||
Disease: | ||
Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2016-001004-33 | Sponsor Protocol Number: VX15-809-115 | Start Date*: 2018-01-10 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: 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 t... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2010-020413-90 | Sponsor Protocol Number: VX09-809-102 | Start Date*: 2011-01-06 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and L... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Completed) BE (Completed) GB (Completed) IE (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2017-003761-99 | Sponsor Protocol Number: VX16-809-121 | Start Date*: 2018-06-27 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: 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 Subjec... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2017-001078-41 | Sponsor Protocol Number: VX13-809-011 | Start Date*: 2017-03-27 | |||||||||||
Sponsor Name: Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: 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, Homozy... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2012-003990-24 | Sponsor Protocol Number: VX12-809-104 | Start Date*: 2013-06-25 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: 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 Wit... | |||||||||||||
Medical condition: Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: BE (Completed) DE (Completed) AT (Completed) GB (Completed) ES (Completed) DK (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2015-000543-16 | Sponsor Protocol Number: VX14-809-109 | Start Date*: 2015-06-19 |
Sponsor Name:Vertex Pharmaceuticals Incorporated | ||
Full Title: 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 Fib... | ||
Medical condition: Cystic Fibrosis | ||
Disease: | ||
Population Age: Children, Under 18 | Gender: Male, Female | |
Trial protocol: GB (Completed) DE (Completed) SE (Completed) DK (Completed) BE (Completed) FR (Completed) | ||
Trial results: View results |
EudraCT Number: 2017-001309-34 | Sponsor Protocol Number: VX14-809-106 | Start Date*: 2017-03-29 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: 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 ... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2012-003989-40 | Sponsor Protocol Number: VX12-809-103 | Start Date*: 2013-05-07 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: 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 Wit... | |||||||||||||
Medical condition: Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: SE (Completed) IT (Completed) CZ (Completed) DE (Completed) IE (Completed) GB (Completed) NL (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2019-003112-31 | Sponsor Protocol Number: VX16-809-116 | Start Date*: 2019-08-14 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: 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 F50... | |||||||||||||
Medical condition: | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2013-000604-41 | Sponsor Protocol Number: VX12-809-105 | Start Date*: 2014-01-21 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: 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, Homozygo... | |||||||||||||
Medical condition: Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Completed) CZ (Completed) SE (Completed) AT (Completed) BE (Completed) GB (Completed) DE (Completed) NL (Completed) ES (Completed) IE (Completed) DK (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2015-001644-11 | Sponsor Protocol Number: VX15-809-110 | Start Date*: Information not available in EudraCT | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozy... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: SE (Ongoing) GB (Completed) BE (Completed) DK (Completed) DE (Completed) FR (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2016-004996-33 | Sponsor Protocol Number: VX15-809-114 | Start Date*: 2017-05-03 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incoporated | |||||||||||||
Full Title: 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 | |||||||||||||
Medical condition: Cystic fibrosis subjects Homozygous for the F508del-CFTR Mutation | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: ES (Prematurely Ended) | |||||||||||||
Trial results: View results |
EudraCT Number: 2016-000066-34 | Sponsor Protocol Number: VX15-809-112 | Start Date*: 2016-06-24 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: 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 Wi... | |||||||||||||
Medical condition: Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2016-001585-29 | Sponsor Protocol Number: VX15-809-111 | Start Date*: 2016-12-21 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: 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... | |||||||||||||
Medical condition: Cystic fibrosis | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: NL (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2015-004841-13 | Sponsor Protocol Number: VX15-371-101 | Start Date*: 2016-08-08 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Inc. | |||||||||||||
Full Title: 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, Ho... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: IE (Completed) GB (Completed) FR (Completed) CZ (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2020-000250-94 | Sponsor Protocol Number: MAST2 | Start Date*: 2020-07-17 | |||||||||||
Sponsor Name:ISTITUTO AUXOLOGICO ITALIANO | |||||||||||||
Full Title: Mutation-specific therapy for the long QT syndrome | |||||||||||||
Medical condition: Long QT syndrome | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Prematurely Ended) | |||||||||||||
Trial results: View results |
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