WHO ICTRP trial
A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in…
EUCTR2016-000454-36-AT · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2016-000454-36-AT |
|---|---|
| Public title | A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis |
| Scientific title | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis |
| Primary sponsor | Vertex Pharmaceuticals Incorporated |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | United States;Canada;Belgium;Spain;Denmark;Australia;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden |
| Conditions | Cystic fibrosis MedDRA version: 19.1 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] |
| Interventions | Product Name: VX-440 Pharmaceutical Form: Tablet INN or Proposed INN: VX-440 Other descriptive name: VX-440 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Tablet… |
| Registration date | Jul 10, 2016 |
| Target size | 198 |
| Secondary IDs | VX15-440-101;2016-000454-36-GB |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: