Status:
COMPLETED
Safety And Tolerability Of Subcutaneous MANP In Difficult To Control/Resistant Hypertensive Subjects
Lead Sponsor:
E-Star BioTech, LLC
Collaborating Sponsors:
Mayo Clinic
Integrium
Conditions:
Resistant Hypertension
Difficult to Control Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
A randomized, double-blind, placebo-controlled multiple ascending dose study in hypertensive subjects on stable doses of at least three hypertensive drugs for at least 6 weeks prior to Screening. The ...
Eligibility Criteria
Inclusion
- DTC/RH diagnosed with clinic SBP ≥140 mmHg or DBP ≥ 90 mmHg (or SBP ≥ 130 mmHg or DBP ≥ 80 mmHg for diabetics) while on at least three standard-of-care antihypertensive medications (which must include a diuretic).
- MDRD eGFR ≥ 30 mL/min.
- Men and women between the ages of 18 - 80.
- BMI within the range of 18-40 kg/m2.
- Women of childbearing potential must not be pregnant and agree to avoid becoming pregnant while receiving study treatment and for 14 days after the last study visit.
Exclusion
- HbA1c ≥ 8% at Screening.
- Use of other investigational drugs within 30 days of screening or foreseen use during the study.
- Inability to comply with study requirements as judged by the Investigator.
- Pregnant and/or breastfeeding.
- Any disease or condition (medical or surgical) which, in the opinion of the investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk.
Key Trial Info
Start Date :
December 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT05247528
Start Date
December 20 2021
End Date
October 31 2022
Last Update
November 29 2022
Active Locations (5)
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1
USA Clinical Site 03
Anniston, Alabama, United States, 36207
2
USA Clinical Site 01
Tustin, California, United States, 92780
3
USA Clinical Site 02
DeLand, Florida, United States, 32738
4
USA Clinical Site 04
Decatur, Georgia, United States, 30030