Difficult to Control Hypertension study: MANP
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 injectable medicine being studied for difficult to control hypertension. is designed to lower blood pressure by acting like a natural body chemical called atrial natriuretic peptide.
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 study aims to find out if a new medicine called MANP is safe and if it lowers blood pressure better than a fake shot.
- Who it's for
- The study is looking for adults with high blood pressure who are already taking at least three different blood pressure medications.
- What's involved
- Participants will receive either the new injection or a placebo shot. They will also wear a special monitor to track their blood pressure for 24 hours.
- Time commitment
- The study involves regular visits to the clinic for check-ups and blood pressure monitoring over a set period.
- 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
- 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 2 or more antihypertensive drugs with different mechanisms of action.
- people must have a seated (5 minutes) systolic blood pressure ≥ 140 mmHg and SBP ≥130 mmHg by ABPM prior to randomization (T1).
- people must have a CKD-EPI eGFR ≥ 30 mL/min/1.73m2
You likely can't join if
- 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
- people who have an implanted cardioverter defibrillator (ICD) that has been fired for any arrhythmia within 3 months of Screening (SV) or implanted...
- people with congestive heart failure (New York Heart Association [NYHA] class II-IV)
See the full eligibility criteria
- 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 2 or more antihypertensive drugs with different mechanisms of action.
- people must have a seated (5 minutes) systolic blood pressure ≥ 140 mmHg and SBP ≥130 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 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
- 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 is enrolling
- Little Rock, Arkansas, United States
- Lake Forest, California, United States
- Westlake Village, California, United States
- Daytona Beach, Florida, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- Acworth, Georgia, United States
- Union City, Georgia, United States
- Chicago, Illinois, United States
- Dearborn, Michigan, United States
- Flint, Michigan, United States
- Ridgeland, Mississippi, United States
- New York, New York, United States
- Monroe, North Carolina, United States
- Dallas, Texas, United States
- Denton, Texas, United States
- Houston, Texas, United States
- Mansfield, Texas, United States
- Plano, Texas, United States
- Richmond, Texas, United States
+ 1 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, but 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?
This study is enrolling now at Little Rock, Arkansas, United States; Lake Forest, California, United States; Westlake Village, California, United States; Daytona Beach, Florida, United States; Hollywood, Florida, United States; Miami, Florida, United States and 15 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.