Trials / Completed
CompletedNCT02765633
Cangrelor Neonatal PK/PD and Safety Study
A Prospective, Open-Label, Single-Arm, Multi-Center Study To Assess The Pharmacokinetics/Pharmacodynamics (PK/PD) And Safety Of Different Cangrelor Doses In Neonatal Subjects At Risk Of Thrombosis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Chiesi Farmaceutici S.p.A. · Industry
- Sex
- All
- Age
- 1 Day – 28 Days
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the PK/PD and safety profile of cangrelor in neonatal participants at risk of thrombosis.
Conditions
- Partial Obstruction of Systemic to Pulmonary Artery Shunt
- Complete Obstruction of Systemic to Pulmonary Artery Shunt
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cangrelor |
Timeline
- Start date
- 2017-01-03
- Primary completion
- 2019-08-31
- Completion
- 2019-12-23
- First posted
- 2016-05-06
- Last updated
- 2023-02-15
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02765633. Inclusion in this directory is not an endorsement.