Status:
COMPLETED
Firibastat in Treatment-resistant Hypertension
Lead Sponsor:
Quantum Genomics SA
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a double-blind, placebo-controlled, multicenter, efficacy and safety study of firibastat (QGC001) administered po bid over 12 weeks in male and female subjects ≥18 years of age at Screening, w...
Detailed Description
The primary objective of this study is to assess the effects of administration of firibastat (QGC001) 500 mg oral (po) twice daily (bis in die \[bid\]) on blood pressure (BP) over 12 weeks in subjects...
Eligibility Criteria
Inclusion
- Men and women ≥18 years of age at Screening
- Diagnosis of primary HTN for at least 6 months prior to Screening
Exclusion
- Known or suspected secondary HTN (eg, hyperaldosteronism, renovascular HTN, pheochromocytoma, Cushing's disease).
- Automated office SBP \>180 mmHg or DBP \>110 mmHg at the Screening or Inclusion Visit (Visit 2, Day 1) and confirmed by a second measurement within 30 minutes to 1 hour.
- Known hypertensive retinopathy (Keith-Wagener Grade 3 or Grade 4) and/or hypertensive encephalopathy.
Key Trial Info
Start Date :
June 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2022
Estimated Enrollment :
515 Patients enrolled
Trial Details
Trial ID
NCT04277884
Start Date
June 25 2020
End Date
September 20 2022
Last Update
October 20 2022
Active Locations (20)
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1
Central Alabama Research
Birmingham, Alabama, United States, 35209-8401
2
Marvel Clinical Research
Huntington Beach, California, United States, 92647
3
Orange County Research Center
Tustin, California, United States, 92780
4
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216