VX-661 Plus Ivacaftor Combination ( DrugBank: Ivacaftor )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 299 | 嚢胞性線維症 | 2 |
299. 嚢胞性線維症
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
| No. | 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 | NCT02516410 (ClinicalTrials.gov) | August 2015 | 28/7/2015 | A 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 | 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 | Drug: VX-661 plus ivacaftor combination;Drug: Ivacaftor;Drug: Placebo (matched to VX-661 plus ivacaftor combination);Drug: Placebo (matched to ivacaftor) | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 168 | Phase 3 | United States;Australia;Austria;Canada;France;Israel;Spain |
| 2 | NCT02347657 (ClinicalTrials.gov) | January 2015 | 12/1/2015 | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor | 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 | Drug: VX-661 Plus Ivacaftor Combination;Drug: Ivacaftor;Drug: VX-661 Plus Ivacaftor Combination Placebo;Drug: Ivacaftor placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 510 | Phase 3 | United States;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom |