To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension
NCT ID: NCT06343298
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2024-11-17
2026-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo-matched control
Placebo-matched vehicle (vehicle minus the active component)
Placebo Matched control
This is a placebo matched vehicle - Vehicle minus the active ingredient
MANP
MANP in vehicle
MANP
MANP (modified atrial natriuretic peptide) is a peptide that is being developed for treatment of difficult to control/resistant hypertension.
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 which must be a diuretic and the other must be an ACEi or ARB at atleast 50% of the maximum recommended dose for hypertension.
* Subjects must have a seated (5 minutes) systolic blood pressure ≥ 140 mmHg and SBP ≥135 mmHg by ABPM prior to randomization (T1).
* Subjects must have a CKD-EPI eGFR ≥ 30 mL/min/1.73m2
* A subset of the subjects with an eGFR between 20-30 ml/min/1.73m2 will be included, not to exceed 10% of the total study subjects.
* Subjects must have a BMI between 18 - 40 kg/m2.
* Subjects who engage in sexual intercourse in which their partner could become pregnant must agree to use a barrier method of birth control (i.e., vaginal/penile condom) with spermicide for the duration of the study and for 90 days after the last dose of study drug or be at least 6 weeks post-vasectomy with confirmation by post-vasectomy semen analysis. In addition, subjects may not donate sperm for the duration of the study and for 90 days after the last dose of study drug.
Exclusion Criteria
* Subjects with an average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥ 110 mmHg at Screening (SV), or prior to randomization at T1.
* Subjects with a history of secondary hypertension, including but not limited to coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's disease, pheochromocytoma, and polycystic kidney disease. If the subject has not previously been evaluated for secondary hypertension, investigators are responsible for evaluating all potential secondary causes of hypertension in accordance with current practices and clinical guidelines before entering the patient into the study.
* Subjects with an HbA1c ≥ 8% at screening (SV)
* Subjects who have experienced myocardial infarction, unstable angina, or a cerebrovascular accident (CVA) within 6 months of the Screening Visit; or sick sinus syndrome or second- or third-degree atrioventricular block, or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia.
* Subjects who have an implanted cardioverter defibrillator (ICD) that has been fired for any arrhythmia within 3 months of Screening (SV) or implanted pacemakers.
* Subjects with congestive heart failure (New York Heart Association \[NYHA\] class II-IV)
* Subjects with hemodynamically significant valvular heart disease
* Subjects undergoing hemodialysis or peritoneal dialysis, or history of renal transplant.
* Subjects who have diagnosis or recurrence of malignancy within the past 3 years
* Subjects with a documented history of sleep apnea, with a prescription for CPAP therapy.
* Women of childbearing potential
* Subjects who are pregnant or breastfeeding
18 Years
80 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
PPD Development, LP
INDUSTRY
E-Star BioTech, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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David Smith, MD
Role: STUDY_DIRECTOR
E-Star BioTech, LLC
Locations
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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
Countries
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Central Contacts
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Lucia Gonzalez
Role: CONTACT
Facility Contacts
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Other Identifiers
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ES_MANP_2001
Identifier Type: -
Identifier Source: org_study_id
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