WHO ICTRP trial
Botulinum toxin type A (AGN-151607) for the prevention of post operative atrial…
EUCTR2017-004399-68-GB · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2017-004399-68-GB |
|---|---|
| Public title | Botulinum toxin type A (AGN-151607) for the prevention of post operative atrial fibrillation in patients undergoing open-chest cardiac surgery |
| Scientific title | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A (AGN 151607) Injections into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac Surgery |
| Primary sponsor | Allergan Ltd. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| 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;Spain;Austria;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden |
| Conditions | Post-operative atrial fibrillation (POAF) MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] |
| Interventions | Product Name: Clostridium botulinum neurotoxin type A (BoNT/A) complex Product Code: AGN-151607 Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: NA CAS Number: 1883793-14-3 Current Sponsor code: AGN-151607… |
| Registration date | Sep 20, 2018 |
| Target size | 330 |
| Secondary IDs | 1925-201-008;135000 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: