Firibastat in Treatment-resistant Hypertension
- Registration Number
- NCT04277884
- Lead Sponsor
- Quantum Genomics SA
- 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, with uncontrolled primary HTN. Subjects will be randomized 1:1 to investigational product (IP) and will receive either firibastat (QGC001) or matching placebo on top of their current chronic antihypertensive treatments.
- 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 with uncontrolled primary HTN.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 515
- Men and women ≥18 years of age at Screening
- Diagnosis of primary HTN for at least 6 months prior to Screening
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Firibastat Firibastat Capsules Placebo Placebo Matching capsules
- Primary Outcome Measures
Name Time Method Systolic Blood Pressure at office (mmHg) From Day 1 to Day 84 Automatic Office Blood Pressure measurement
- Secondary Outcome Measures
Name Time Method Diastolic Blood Pressure at office (mmHg) From Day 1 to Day 84 Automatic Office Blood Pressure measurement
Mean 24-hour ambulatory Diastolic Blood Pressure (mmHg) From Day 1 to Day 84 Ambulatory Blood Pressure Monitoring
Mean 24-hour ambulatory Systolic Blood Pressure (mmHg) From Day 1 to Day 84 Ambulatory Blood Pressure Monitoring
Trial Locations
- Locations (20)
Orange County Research Center
🇺🇸Tustin, California, United States
Apex Medical Research
🇺🇸Chicago, Illinois, United States
Cedar Crosse Research Center
🇺🇸Chicago, Illinois, United States
Juno Research - Corporate Office
🇺🇸Houston, Texas, United States
Marvel Clinical Research
🇺🇸Huntington Beach, California, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Sterling Research Group - Cincinnati / Mount Auburn
🇺🇸Cincinnati, Ohio, United States
Ambulatorium Barbara Bazela
🇵🇱Elbląg, Żuławy, Poland
Insearch - R&H Clinical Research
🇺🇸Katy, Texas, United States
ClinEdge - Dayton Clinical Research
🇺🇸Dayton, Texas, United States
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
Les Hôpitaux Universitaires de Strasbourg
🇫🇷Strasbourg, Grand Est, France
Insearch - Punzi Medical Center
🇺🇸Carrollton, Texas, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Fakultní nemocnice v Motole
🇨🇿Prague, Czechia
Cardiovascular Center of Sarasota
🇺🇸Sarasota, Florida, United States
Universitätsklinikum Schleswig-Holstein - Campus Kiel
🇩🇪Kiel, Germany
ClinEdge - Chear Center
🇺🇸Bronx, New York, United States
Central Alabama Research
🇺🇸Birmingham, Alabama, United States