Lumacaftor plus ivacaftor (DrugBank: Ivacaftor, Lumacaftor)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 299 | Cystic fibrosis | 4 |
| 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 | NCT02807415 (ClinicalTrials.gov) | June 1, 2016 | 16/6/2016 | ICM to Evaluate the Activation of p.Phe508del-CFTR by Lumacaftor in Combination With Ivacaftor | Intestinal Current Measurements (ICM) to Evaluate the Activation of Mutant CFTR in Subjects With Cystic Fibrosis Aged 12 Years and Older, Homozygous for the p.Phe508del-CFTR Mutation, Treated With Lumacaftor in Combination With Ivacaftor | Cystic Fibrosis | Drug: Lumacaftor plus Ivacaftor | Hannover Medical School | Heidelberg University;University of Giessen | Completed | 6 Years | N/A | All | 104 | Germany | |
| 2 | NCT01931839 (ClinicalTrials.gov) | October 2013 | 26/8/2013 | A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis | 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, Homozygous or Heterozygous for the F508del-CFTR Mutation | Drug: Lumacaftor Plus Ivacaftor Combination;Drug: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 1164 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czech Republic;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom |
| 3 | NCT01807923 (ClinicalTrials.gov) | May 2013 | 4/3/2013 | A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation | 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, Homozygous for the F508del CFTR Mutation | Drug: Lumacaftor Plus Ivacaftor Combination;Drug: Ivacaftor;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 559 | Phase 3 | United States;Australia;Canada;Czech Republic;France;Germany;Ireland;Italy;Netherlands;Sweden;United Kingdom |
| 4 | NCT01807949 (ClinicalTrials.gov) | April 2013 | 4/3/2013 | A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation | 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, Homozygous for the F508del CFTR Mutation | Drug: Placebo;Drug: Lumacaftor Plus Ivacaftor Combination;Drug: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | 65 Years | All | 563 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Spain;United Kingdom |