Effect of PRM-125 on Ambulatory Blood Pressure

NCT05195827 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: CTD-3001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in 24 hour Systolic Blood Pressure

  8 weeks

Secondary Outcomes (1)

• Change in 24 hour Diastolic Blood Pressure

  8 weeks

Study Arms (1)

PRM125

EXPERIMENTAL

PRM125

Drug: PRM-125

Interventions

PRM-125 DRUG

Antihypertensive

PRM125

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary hypertension

You may not qualify if:

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

Sponsors & Collaborators

• PRM Pharma, LLC: lead

Study Sites (1)

AMR

Coral Gables, Florida, 33134, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2022
• First Posted: January 19, 2022
• Study Start: December 20, 2021
• Primary Completion: September 30, 2022
• Study Completion: November 30, 2022
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)