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A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453 in Healthy Male Volunteers
The purpose of this study is to assess the tolerability of BIA 5-453 after six multiple rising dose regimens of BIA 5-453.
Details
| Lead sponsor | Bial - Portela C S.A. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 57 |
| Start date | 2007-09 |
| Completion | 2008-07 |
Conditions
- Hypertension
- Chronic Heart Failure
Interventions
- BIA 5-453
- Placebo
Primary outcomes
- Percent of subjects with at least one adverse event — through study completion, an average of 10 days
- Percent of subjects by dose group with at least one treatment-emergent adverse event (TEAEs) — through study completion, an average of 10 days
Treatment-emergent adverse events are adverse events that occurred either in the 72 hours after dosing or that was present prior to dosing but exacerbated within 72 hours after dosing.