A Phase 3 interventional study of Firibastat and Placebo in Hypertension, sponsored by Quantum Genomics SA. Completed at 20 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-20.
Sponsored by Quantum Genomics SA · Phase 3, Interventional, and Treatment
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.
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 515 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Quantum Genomics SA is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Capsules
Drug: Firibastat
Matching capsules
Drug: Placebo
Oral administration 2×250 mg capsules bid
Also known as: QGC001
Oral administration 2 capsules bid
Systolic Blood Pressure at office (mmHg)
Automatic Office Blood Pressure measurement
Time frame: From Day 1 to Day 84
Diastolic Blood Pressure at office (mmHg)
Automatic Office Blood Pressure measurement
Time frame: From Day 1 to Day 84
Mean 24-hour ambulatory Systolic Blood Pressure (mmHg)
Ambulatory Blood Pressure Monitoring
Time frame: From Day 1 to Day 84
Mean 24-hour ambulatory Diastolic Blood Pressure (mmHg)
Ambulatory Blood Pressure Monitoring
Time frame: From Day 1 to Day 84
Plan to share: No
Ran from Jun 2020 to primary completion in Aug 2022, 26 months.
Of 178 industry-sponsored phase 3 interventional studies under Hypertension, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 38. This study's 26 months is above that.
Counting every sponsor, half of 229 studies reached it within 23 months; a quarter within 13 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Firibastat
Quantum Genomics SA