Firibastat in Treatment-resistant Hypertension
Completed · Phase 3 · Has a placebo group
Conditions studied: Hypertension
In brief
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.
Key facts
- Study ID
- NCT04277884
- Run by
- Quantum Genomics SA
- People needed
- 515
- Starts
- 2020-06-25
- Expected to finish
- 2022-09-20
- Last updated by the study team
- 2022-10-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men and women ≥18 years of age at Screening
- Diagnosis of primary HTN for at least 6 months prior to Screening
You may not qualify if…
- 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.
Where it is running
- Central Alabama Research — Birmingham, Alabama, United States
- Marvel Clinical Research — Huntington Beach, California, United States
- Orange County Research Center — Tustin, California, United States
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
- Progressive Medical Research — Port Orange, Florida, United States
- Cardiovascular Center of Sarasota — Sarasota, Florida, United States
- Apex Medical Research — Chicago, Illinois, United States
- Cedar Crosse Research Center — Chicago, Illinois, United States
- ClinEdge - Chear Center — The Bronx, New York, United States
- Sterling Research Group - Cincinnati / Mount Auburn — Cincinnati, Ohio, United States
- Insearch - Punzi Medical Center — Carrollton, Texas, United States
- ClinEdge - Dayton Clinical Research — Dayton, Texas, United States
- Juno Research - Corporate Office — Houston, Texas, United States
- Insearch - R&H Clinical Research — Katy, Texas, United States
- Manassas Clinical Research Center — Manassas, Virginia, United States
- Fakultní nemocnice v Motole — Prague, Czechia
- Les Hôpitaux Universitaires de Strasbourg — Strasbourg, Grand Est, France
- Universitätsklinikum Schleswig-Holstein - Campus Kiel — Kiel, Germany
- Ambulatorium Barbara Bazela — Elblag, Żuławy, Poland
- Hospital Universitario de La Princesa — Madrid, Spain
Full record on ClinicalTrials.gov
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