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To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension
Sponsor: E-Star BioTech, LLC
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-11-17
Completion Date
2026-09-01
Last Updated
2025-10-06
Healthy Volunteers
No
Conditions
Interventions
MANP
MANP (modified atrial natriuretic peptide) is a peptide that is being developed for treatment of difficult to control/resistant hypertension.
Placebo 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