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Alpha-1 Adrenergic Receptor Antagonist
A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline
Phase 1
Waitlist Available
Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing how well Prazosin and Propranolol can manage blood pressure in patients who are already taking Brexpiprazole or Sertraline. Prazosin helps by relaxing blood vessels, while Propranolol works by slowing down the heart. The goal is to see if these medications can help control blood pressure issues caused by the mental health treatments.
Eligible Conditions
- PTSD
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 21 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes between the control and treatment periods on Day 19 vs. Day 1, Day 20 vs. Day 2, and Day 21 vs. Day 3, with prazosin or propanolol in the presence of brexpiprazole + sertraline or sertraline alone at steady state
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Sertraline alone at steady stateActive Control2 Interventions
To assess the hemodynamic changes associated with the effects of a single dose of prazosin or propranolol in the presence of brexpiprazole + sertraline at steady state compared with a single dose of prazosin or propranolol in the presence of sertraline alone at steady state.
Group II: Sertraline + brexpiprazole at steady stateActive Control2 Interventions
To assess the hemodynamic changes associated with the effects of a single dose of prazosin or propranolol in the presence of brexpiprazole + sertraline at steady state compared with a single dose of prazosin or propranolol in the presence of sertraline alone at steady state.
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Who is running the clinical trial?
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
266 Previous Clinical Trials
169,078 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
118 Previous Clinical Trials
176,796 Total Patients Enrolled