Firibastat in Treatment-resistant Hypertension

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Firibastat; Drug: Placebo

• 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.

Study Timeline

• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-20
• Study Start: 2020-06-25
• Primary Completion: 2022-08-30
• Study Completion: 2022-09-20
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 515

Inclusion Criteria

• Men and women ≥18 years of age at Screening
• Diagnosis of primary HTN for at least 6 months prior to Screening

Exclusion Criteria

• 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)

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; 🇺🇸 Bronx, New York, United States

Sterling Research Group - Cincinnati / Mount Auburn; 🇺🇸 Cincinnati, Ohio, United States

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