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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
MANP (modified atrial natriuretic peptide) is a peptide that is being developed for treatment of difficult to control/resistant hypertension.
This is a placebo matched vehicle - Vehicle minus the active ingredient
Change from baseline in mean daytime SBP derived from 24-hour ABPM at approximately Day 42.
ABPM
Time frame: Approximately 42 days
Incidence and severity of Adverse events through 4- weeks post end of treatment.
Safety
Time frame: Approximately 10 weeks
Incidence and severity of Serious Adverse Events through 4- weeks post end of treatment.
Safety
Time frame: Approximately 10 weeks
Incidence and severity of Treatment Emergent Adverse Events through 4- weeks post end of treatment.
Safety
Time frame: Approximately 10 weeks
Change in Clinic sitting systolic blood pressure
Achieving mean seated (5 minutes) systolic blood pressure blood pressure control ≤ 130 mmHg at end of treatment visit.
Time frame: Approximately 42 days
Pharmacokinetics - Cmax
Maximum concentration of MANP in plasma post dose on Day 1 and Last day of Treatment
Time frame: Approximately 42 days
Pharmacokinetics - Tmax
Time required to achieve maximum concentration of MANP in plasma post dose on Day 1 and Last day of Treatment
Time frame: Approximately 42 Days
Anti-drug Antibody
Change in Anti-drug antibodies against MANP and ANP at Days 21 and 42 post treatment and at follow up visits 1 and 2 compared to baseline
Lucia Gonzalez
CONTACT
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