To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension

Conditions

• Difficult to Control Hypertension

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• MANP — DRUG
  MANP (modified atrial natriuretic peptide) is a peptide that is being developed for treatment of difficult to control/resistant hypertension.
• Placebo Matched control — OTHER
  This is a placebo matched vehicle - Vehicle minus the active ingredient

Study Details

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.

Key Dates

First listed

Apr 2, 2024

Start date

Nov 17, 2024

Status verified

Sep 2026

Primary completion

Jul 1, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo-matched control
  Placebo-matched vehicle (vehicle minus the active component)
• Active Comparator: MANP
  MANP in vehicle

Primary Outcome Measure

Change from baseline in mean daytime SBP derived from 24-hour ABPM at approximately Day 42. [ Time Frame: Approximately 42 days ]

Central Contacts

• Seetha R Iyer, MS
  212-271-4295
  [email protected]
• Lucia Gonzalez

Locations (23)

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