NCT04277884

Firibastat in Treatment-resistant Hypertension

A Phase 3, Double-blind, Placebo-controlled, Efficacy and Safety Study of Firibastat (QGC001) Administered Orally, Twice Daily, Over 12 Weeks in Difficult-to-treat/Resistant Hypertensive Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 515 (actual)
• Sponsor: Quantum Genomics SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Firibastat	Oral administration 2×250 mg capsules bid
DRUG	Placebo	Oral administration 2 capsules bid

Timeline

• Start date: 2020-06-25
• Primary completion: 2022-08-30
• Completion: 2022-09-20
• First posted: 2020-02-20
• Last updated: 2022-10-20

Locations

20 sites across 6 countries: United States, Czechia, France, Germany, Poland, Spain

Regulatory

• FDA-regulated drug study