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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04277884
Other study ID # QGC001-3QG1
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 25, 2020
Est. completion date September 20, 2022

Study information

Verified date October 2022
Source Quantum Genomics SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 515
Est. completion date September 20, 2022
Est. primary completion date August 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Firibastat
Oral administration 2×250 mg capsules bid
Placebo
Oral administration 2 capsules bid

Locations

Country Name City State
Czechia Fakultní nemocnice v Motole Prague
France Les Hôpitaux Universitaires de Strasbourg Strasbourg Grand Est
Germany Universitätsklinikum Schleswig-Holstein - Campus Kiel Kiel
Poland Ambulatorium Barbara Bazela Elblag Zulawy
Spain Hospital Universitario de La Princesa Madrid
United States Central Alabama Research Birmingham Alabama
United States ClinEdge - Chear Center Bronx New York
United States Insearch - Punzi Medical Center Carrollton Texas
United States Apex Medical Research Chicago Illinois
United States Cedar Crosse Research Center Chicago Illinois
United States Sterling Research Group - Cincinnati / Mount Auburn Cincinnati Ohio
United States ClinEdge - Dayton Clinical Research Dayton Texas
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 Insearch - R&H Clinical Research Katy Texas
United States Manassas Clinical Research Center Manassas Virginia
United States Progressive Medical Research Port Orange Florida
United States Cardiovascular Center of Sarasota Sarasota Florida
United States Orange County Research Center Tustin California

Sponsors (1)

Lead Sponsor Collaborator
Quantum Genomics SA

Countries where clinical trial is conducted

United States,  Czechia,  France,  Germany,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Systolic Blood Pressure at office (mmHg) Automatic Office Blood Pressure measurement From Day 1 to Day 84
Secondary Diastolic Blood Pressure at office (mmHg) Automatic Office Blood Pressure measurement From Day 1 to Day 84
Secondary Mean 24-hour ambulatory Systolic Blood Pressure (mmHg) Ambulatory Blood Pressure Monitoring From Day 1 to Day 84
Secondary Mean 24-hour ambulatory Diastolic Blood Pressure (mmHg) Ambulatory Blood Pressure Monitoring From Day 1 to Day 84
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