Effect of PRM-125 on Ambulatory Blood Pressure

Phase 3

Withdrawn

• Conditions: Hypertension
• Interventions: Drug: PRM-125

• Registration Number: NCT05195827
• Lead Sponsor: PRM Pharma, LLC

Brief Summary

Evaluation of Once-Daily PRM125 On Ambulatory Blood Pressure in Adults with Hypertension

Detailed Description

Approximately 60 subjects with primary hypertension are treated for 8 weeks with PRM125 to determine if Ambulatory Blood Pressure is changed.

Study Timeline

• Study Start: 2021-12-20
• Study First Submitted: 2022-01-02
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-19
• Primary Completion: 2022-09-30
• Study Completion: 2022-11-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• primary hypertension

Exclusion Criteria

• medical conditions that preclude evaluation and/or adversely effect subject safety

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRM125	PRM-125	PRM125

Primary Outcome Measures

Name	Time	Method
Change in 24 hour Systolic Blood Pressure	8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in 24 hour Diastolic Blood Pressure	8 weeks

Trial Locations

Locations (1)

AMR; 🇺🇸 Coral Gables, Florida, United States