Study of Once Daily Firibastat Medication for High Blood Pressure
Protocol: STUDY00005686
Full Title
A Phase 3, double-blind, placebo-controlled and open-label efficacy and long-term safety study of firibastat administered orally, once daily, for up to 48 weeks in patients with difficult-to-treat/resistant hypertension
Description
This study will look how safe and effective the investigational drug firibastat (not yet approved for market) is. On top of your current medication, you will receive either firibastat(half of all participants) or placebo (half of all participants) for the first 12-weeks followed by open-label study treatment with firibastat for 24 or 36-weeks; the placebo looks exactly the same as the investigational drug, but contains no active medicine. The group you are in will be selected at random. The study medication and placebo will be taken by mouth once daily.

Technical Description

(CSR 210634171376) To assess the effects of firibastat administered at 1000 mg orally, once daily, on blood pressure over 12 weeks. To assess the safety of firibastat administered at 1000 mg daily over 24 weeks and 48 weeks. To assess the change in blood pressure over time.
Compensation: Yes
?
Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Eligibility
Must be >=18 years of age
Diagnosis of primary hypertension (high blood pressure) for at least 6 months prior to screening
Currently treated with at least 2 high blood pressure medications
Have a systolic office blood pressure between 140 mmHg and 179 mmHg at screening
Have a systolic home blood pressure with a mean 135 mmHg after the run-in period
Age Group: Adults
Principal Investigator: JOSEPH IZZO
ClinicalTrials.gov: Open Study
Contact(s)
KELLEY CAROZZOLO (Bilson)
kjc28@buffalo.edu
+1 716-898-5653
Want to Learn More?
Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email ctsiresearch@buffalo.edu and someone will assist you.