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Trazodone QT/QTc Study in Healthy Volunteers
NCT03516630Phase 1Completed
- Sponsor
- Angelini Pharma
- Start
- Mar 2017
- Primary completion
- May 2017
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial of trazodone hydrochloride prolonged-release tablets in major depressive disorder (MDD) (5 arms), sponsored by Angelini Pharma. Primary endpoints: Relationship between trazodone plasma concentration and QTc at 24 hours and Influence of trazodone on QTc (Placebo-adjusted and corrected for HR based on the Fridericia correction method) at 24 hours. Started Mar 2017; status: completed.
02
Drugs
trazodone hydrochloride prolonged-release tablets
03
Conditions
major depressive disorder (MDD)
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