Clinical trial
A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
Actual Study Start Date: April 17, 2019
Estimated Primary Completion Date: June 2020
Estimated Study Completion Date: June 2020
Arms:
- Experimental: VX-561
- Active Comparator: IVA
| Category | Value |
|---|---|
| Date last updated at source | 2019-09-13 |
| Study type(s) | Interventional |
| Expected enrolment | 88 |
| Study start date | 2019-04-17 |
| Estimated primary completion date | 2020-06-01 |