A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE TITRATION, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS MANP WHEN ADMINISTERED ONCE DAILY FOR 42 DAYS IN PARTICIPANTS WITH DIFFICULT TO CONTROL HYPERTENSION/RESISTANT HYPERTENSION
E-Star BioTech, LLC
Summary
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.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening: * 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 ≥ 1…
Interventions
- DrugMANP
MANP (modified atrial natriuretic peptide) is a peptide that is being developed for treatment of difficult to control/resistant hypertension.
- OtherPlacebo Matched control
This is a placebo matched vehicle - Vehicle minus the active ingredient
Locations (29)
- Lynn Institute of the OzarksLittle Rock, Arkansas
- Amicis Research Center - Beverly HillsBeverly Hills, California
- Amicis Research Center - Granada HillsGranada Hills, California
- Orange County Research CenterLake Forest, California
- Amicis Research Center - PalmdalePalmdale, California
- Amicis Research Site - ValenciaValencia, California