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Tests treatment safety and results for Difficult to Control Hypertension
Official title To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension
ClinicalTrials.gov ID: NCT06343298
What this study is testing
What is MANP?
MANP is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for difficult to control hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- people will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening:
- Male or female people aged 18 - 80 years, inclusive, at the screening visit.
- Female people must not be of childbearing potential
- people must be taking appropriate doses of 3 or more antihypertensive drugs with different mechanisms of action. One of which must be a diuretic and...
- people must have a seated (5 minutes) systolic blood pressure ≥ 140 mmHg and SBP ≥135 mmHg by ABPM prior to randomization (T1).
You likely can't join if
- people meeting ANY of the following criteria at time of Screening will be excluded from enrollment:
- people with an average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥ 110 mmHg at Screening (SV), or prior to randomization...
- people with a history of secondary hypertension, including but not limited to coarctation of the aorta, primary hyperaldosteronism, renal artery...
- people with an HbA1c ≥ 8% at screening (SV)
- people who have experienced myocardial infarction, unstable angina, or a cerebrovascular accident (CVA) within 6 months of the Screening Visit; or...
- people who have an implanted cardioverter defibrillator (ICD) that has been fired for any arrhythmia within 3 months of Screening (SV) or implanted...
See the full eligibility criteria
- people will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening:
- Male or female people aged 18 - 80 years, inclusive, at the screening visit.
- Female people must not be of childbearing potential
- people 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...
- people must have a seated (5 minutes) systolic blood pressure ≥ 140 mmHg and SBP ≥135 mmHg by ABPM prior to randomization (T1).
- people must have a CKD-EPI eGFR ≥ 30 mL/min/1.73m2
- A subset of the people with an eGFR between 20-30 ml/min/1.73m2 will be included, not to exceed 10% of the total study people.
- people must have a BMI between 18 - 40 kg/m2.
- people 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...
- people meeting ANY of the following criteria at time of Screening will be excluded from enrollment:
- people with an average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥ 110 mmHg at Screening (SV), or prior to randomization at T1.
- people 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...
- people with an HbA1c ≥ 8% at screening (SV)
- people 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...
- people who have an implanted cardioverter defibrillator (ICD) that has been fired for any arrhythmia within 3 months of Screening (SV) or implanted pacemakers.
- people with congestive heart failure (New York Heart Association [NYHA] class II-IV)
- people with hemodynamically significant valvular heart disease
- people undergoing hemodialysis or peritoneal dialysis, or history of renal transplant.
- people who have diagnosis or recurrence of malignancy within the past 3 years
- people with a documented history of sleep apnea, with a prescription for CPAP therapy.
- Women of childbearing potential
- people who are pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Beverly Hills, California, United States
- Granada Hills, California, United States
- Lake Forest, California, United States
- Palmdale, California, United States
- Valencia, California, United States
- West Hills, California, United States
- Westlake Village, California, United States
- Biscayne Park, Florida, United States
- Daytona Beach, Florida, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- Acworth, Georgia, United States
- Peachtree Corners, Georgia, United States
- Chicago, Illinois, United States
- Dearborn, Michigan, United States
- Flint, Michigan, United States
- Monroe, North Carolina, United States
- Smithfield, North Carolina, United States
- Marion, Ohio, United States
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Beverly Hills, California, United States; Granada Hills, California, United States; Lake Forest, California, United States; Palmdale, California, United States; Valencia, California, United States and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.