NCT05189977

A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline

A Phase 1, Open-label, Fixed-sequence, Cross-over Trial to Assess the Effects of a Single Dose of Prazosin or Propranolol in the Presence of Brexpiprazole/Sertraline at Steady-state on Blood Pressure

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline

Conditions

• Post-traumatic Stress Disorder (PTSD)

Interventions

Type	Name	Description
DRUG	Propranolol	Propranolol (tablet, oral ): 40 mg QD Day 3 and Day 21 Intervention 1 is a single dose of prazosin administered in the presence of sertraline alone at steady state or in the presence of sertraline + brexpiprazole at steady state.
DRUG	Prazosin	Prazosin (tablet, oral): 1 mg QD Day 2 and Day 20 Intervention 2 is a single dose of propranolol administered in the presence of sertraline alone at steady state or in the presence of sertraline + brexpiprazole at steady state.

Timeline

• Start date: 2022-09-07
• Primary completion: 2023-08-03
• Completion: 2023-08-03
• First posted: 2022-01-13
• Last updated: 2024-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study