Clinical Trials Logo
  1. Home
  2. Hypertension
  3. NCT04277884
  4. Details
NCT04277884 Clinical Trial

Firibastat in Treatment-resistant Hypertension

Hypertension Clinical Trial

— FRESH  

Official title:
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

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
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A