RecruitingPhase 2NCT06343298

To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE TITRATION, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS MANP WHEN ADMINISTERED ONCE DAILY FOR 42 DAYS IN PARTICIPANTS WITH DIFFICULT TO CONTROL HYPERTENSION/RESISTANT HYPERTENSION

Sponsor

E-Star BioTech, LLC

Enrollment

120 participants

Start Date

Nov 17, 2024

Study Type

INTERVENTIONAL

Conditions

Difficult to Control Hypertension

Summary

This is a Phase 2 dose-titration study designed to evaluate the safety and efficacy of MANP subcutaneous injection compared to placebo in reducing baseline daytime systolic blood pressure (SBP), derived from 24-hour ambulatory blood pressure monitoring (ABPM), in subjects with hypertension who are taking 3 or more antihypertensive medications with different mechanisms of action.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called MANP (a synthetic form of a naturally occurring heart and kidney hormone) in patients with difficult-to-control or resistant high blood pressure — meaning blood pressure that remains dangerously high despite taking 3 or more different blood pressure medications. **You may be eligible if...** - You are between 18 and 80 years old - You are currently taking 3 or more blood pressure medications at appropriate doses, including a diuretic and an ACE inhibitor or ARB - Your seated blood pressure is still at or above 140 mmHg systolic - Your kidney function is at least moderately preserved (eGFR ≥ 30) - Your BMI is between 18 and 40 kg/m² - Women must not be of childbearing potential **You may NOT be eligible if...** - Your blood pressure is controlled - You are a woman of childbearing potential - Your kidney function is severely impaired (unless in a specific sub-group) - You have conditions that would interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMANP

MANP (modified atrial natriuretic peptide) is a peptide that is being developed for treatment of difficult to control/resistant hypertension.

OTHERPlacebo Matched control

This is a placebo matched vehicle - Vehicle minus the active ingredient

Locations(29)

Lynn Institute of the Ozarks

Little Rock, Arkansas, United States

Amicis Research Center - Beverly Hills

Beverly Hills, California, United States

Amicis Research Center - Granada Hills

Granada Hills, California, United States

Orange County Research Center

Lake Forest, California, United States

Amicis Research Center - Palmdale

Palmdale, California, United States

Amicis Research Site - Valencia

Valencia, California, United States

Interventional Cardiology Medical Group

West Hills, California, United States

Office of Dr. Edward Portnoy MD

Westlake Village, California, United States

SM Research Center

Biscayne Park, Florida, United States

Arrow Clinical Trials

Daytona Beach, Florida, United States

Royal Research Corp

Hollywood, Florida, United States

Evolution Clinical Trials

Miami, Florida, United States

Cowry Health

Acworth, Georgia, United States

Alta Pharmaceutical Research Center

Peachtree Corners, Georgia, United States

Cedar Crosse Research Center

Chicago, Illinois, United States

Revival Research Institute, LLC

Dearborn, Michigan, United States

Aa Mrc Llc

Flint, Michigan, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

Superior Clinical Research

Smithfield, North Carolina, United States

K&R Research LLC

Marion, Ohio, United States

Tristar Clinical Investigations, P.C.

Philadelphia, Pennsylvania, United States

Prime Research

Coppell, Texas, United States

Dallas Renal Group

Dallas, Texas, United States

East Texas Cardiology

Houston, Texas, United States

Pioneer Research Solutions

Houston, Texas, United States

Prime Clinical Research

Mansfield, Texas, United States

Clinical Investigations of Texas

Plano, Texas, United States

Aavon Clinical Trials

Richmond, Texas, United States

Revival Research

Sherman, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06343298