Actively Recruiting
To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension
Led by E-Star BioTech, LLC · Updated on 2025-10-06
120
Participants Needed
29
Research Sites
93 weeks
Total Duration
On this page
Sponsors
E
E-Star BioTech, LLC
Lead Sponsor
M
Mayo Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 - 80 years, inclusive, at the screening visit.
- Female subjects must not be of childbearing potential.
- Subjects must be taking appropriate doses of 3 or more antihypertensive drugs with different mechanisms of action.
- One of the antihypertensive drugs must be a diuretic.
- One of the antihypertensive drugs must be an ACE inhibitor or ARB at at least 50% of the maximum recommended dose for hypertension.
- Subjects must have a seated systolic blood pressure of 140 mmHg or higher and an ambulatory blood pressure monitoring systolic blood pressure of 135 mmHg or higher prior to randomization.
- Subjects must have a CKD-EPI estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73m2 or higher.
- Up to 10% of subjects with an eGFR between 20-30 mL/min/1.73m2 may be included.
- Subjects must have a body mass index (BMI) between 18 and 40 kg/m2.
- Subjects who engage in sexual intercourse with partners who could become pregnant must agree to use a barrier method of birth control with spermicide for the duration of the study and for 90 days after the last dose or be at least 6 weeks post-vasectomy with confirmation by semen analysis.
- Subjects may not donate sperm during the study and for 90 days after the last dose of study drug.
You will not qualify if you...
- Subjects with an average sitting systolic blood pressure of 180 mmHg or higher or diastolic blood pressure of 110 mmHg or higher at screening or prior to randomization.
- Subjects with a history of secondary hypertension, including conditions such as coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's disease, pheochromocytoma, and polycystic kidney disease.
- Subjects with an HbA1c of 8% or higher at screening.
- Subjects who have experienced myocardial infarction, unstable angina, or stroke within 6 months of screening.
- Subjects with certain heart rhythm problems, including sick sinus syndrome, second- or third-degree atrioventricular block, recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia.
- Subjects with an implanted cardioverter defibrillator that has fired for arrhythmia within 3 months or implanted pacemakers.
- Subjects with congestive heart failure classified as New York Heart Association class II-IV.
- Subjects with significant valvular heart disease.
- Subjects undergoing hemodialysis or peritoneal dialysis or with a history of renal transplant.
- Subjects with a diagnosis or recurrence of cancer within the past 3 years.
- Subjects with documented sleep apnea using CPAP therapy.
- Women of childbearing potential.
- Subjects who are pregnant or breastfeeding.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States, 72204
Actively Recruiting
2
Amicis Research Center - Beverly Hills
Beverly Hills, California, United States, 90211
Actively Recruiting
3
Amicis Research Center - Granada Hills
Granada Hills, California, United States, 91344
Actively Recruiting
4
Orange County Research Center
Lake Forest, California, United States, 92630
Actively Recruiting
5
Amicis Research Center - Palmdale
Palmdale, California, United States, 93551
Actively Recruiting
6
Amicis Research Site - Valencia
Valencia, California, United States, 91355
Actively Recruiting
7
Interventional Cardiology Medical Group
West Hills, California, United States, 91308
Withdrawn
8
Office of Dr. Edward Portnoy MD
Westlake Village, California, United States, 91361
Actively Recruiting
9
SM Research Center
Biscayne Park, Florida, United States, 33161
Actively Recruiting
10
Arrow Clinical Trials
Daytona Beach, Florida, United States, 32117
Actively Recruiting
11
Royal Research Corp
Hollywood, Florida, United States, 33021
Actively Recruiting
12
Evolution Clinical Trials
Miami, Florida, United States, 33122
Actively Recruiting
13
Cowry Health
Acworth, Georgia, United States, 30101
Actively Recruiting
14
Alta Pharmaceutical Research Center
Peachtree Corners, Georgia, United States, 30092
Actively Recruiting
15
Cedar Crosse Research Center
Chicago, Illinois, United States, 60607
Actively Recruiting
16
Revival Research Institute, LLC
Dearborn, Michigan, United States, 48126
Actively Recruiting
17
Aa Mrc Llc
Flint, Michigan, United States, 48504
Actively Recruiting
18
Monroe Biomedical Research
Monroe, North Carolina, United States, 28112
Actively Recruiting
19
Superior Clinical Research
Smithfield, North Carolina, United States, 27577
Actively Recruiting
20
K&R Research LLC
Marion, Ohio, United States, 43302
Actively Recruiting
21
Tristar Clinical Investigations, P.C.
Philadelphia, Pennsylvania, United States, 19114
Active, Not Recruiting
22
Prime Research
Coppell, Texas, United States, 75019
Active, Not Recruiting
23
Dallas Renal Group
Dallas, Texas, United States, 75230
Actively Recruiting
24
East Texas Cardiology
Houston, Texas, United States, 77002
Actively Recruiting
25
Pioneer Research Solutions
Houston, Texas, United States, 77099
Actively Recruiting
26
Prime Clinical Research
Mansfield, Texas, United States, 76063
Actively Recruiting
27
Clinical Investigations of Texas
Plano, Texas, United States, 75075
Actively Recruiting
28
Aavon Clinical Trials
Richmond, Texas, United States, 77407
Actively Recruiting
29
Revival Research
Sherman, Texas, United States, 75092
Actively Recruiting
Research Team
S
Seetha R Iyer, MS
CONTACT
L
Lucia Gonzalez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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