Effect of PRM-125 on Ambulatory Blood Pressure

March 16, 2023 updated by: PRM Pharma, LLC

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33134
        • AMR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary hypertension

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in 24 hour Systolic Blood Pressure
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in 24 hour Diastolic Blood Pressure
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PRM Pharma, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2021

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

January 2, 2022

First Submitted That Met QC Criteria

January 13, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTD-3001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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