Effect of PRM-125 on Ambulatory Blood Pressure

Sponsor

PRM Pharma, LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05195827

Collaborator

(none)

Enrollment

Location

Arm

11.3

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: PRM-125	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 20, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PRM125 PRM125	Drug: PRM-125 Antihypertensive

Arm

Intervention/Treatment

Experimental: PRM125

PRM125

Drug: PRM-125

Antihypertensive

Outcome Measures

Primary Outcome Measures

Change in 24 hour Systolic Blood Pressure [8 weeks]

Secondary Outcome Measures

Change in 24 hour Diastolic Blood Pressure [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

primary hypertension

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AMR	Coral Gables	Florida	United States	33134

Sponsors and Collaborators

PRM Pharma, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

PRM Pharma, LLC

ClinicalTrials.gov Identifier:

NCT05195827

Other Study ID Numbers:

CTD-3001

First Posted:

Jan 19, 2022

Last Update Posted:

Jul 18, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Jul 18, 2022