Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Firibastat | Experimental | Capsules |
|
| Placebo | Placebo Comparator | Matching capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Firibastat | Drug | Oral administration 2×250 mg capsules bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure at office (mmHg) | Automatic Office Blood Pressure measurement | From Day 1 to Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic Blood Pressure at office (mmHg) | Automatic Office Blood Pressure measurement | From Day 1 to Day 84 |
| Mean 24-hour ambulatory Systolic Blood Pressure (mmHg) | Ambulatory Blood Pressure Monitoring |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| George Bakris, MD | AHA Comprehensive Hypertension Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Alabama Research | Birmingham | Alabama | 35209-8401 | United States | ||
| Marvel Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33027067 | Derived | Khosla J, Aronow WS, Frishman WH. Firibastat: An Oral First-in-Class Brain Aminopeptidase A Inhibitor for Systemic Hypertension. Cardiol Rev. 2022 Jan-Feb 01;30(1):50-55. doi: 10.1097/CRD.0000000000000360. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Oral administration 2 capsules bid |
|
| From Day 1 to Day 84 |
| Mean 24-hour ambulatory Diastolic Blood Pressure (mmHg) | Ambulatory Blood Pressure Monitoring | From Day 1 to Day 84 |
| Huntington Beach |
| California |
| 92647 |
| United States |
| Orange County Research Center | Tustin | California | 92780 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Cardiovascular Center of Sarasota | Sarasota | Florida | 34239 | United States |
| Apex Medical Research | Chicago | Illinois | 60607 | United States |
| Cedar Crosse Research Center | Chicago | Illinois | 60607 | United States |
| ClinEdge - Chear Center | The Bronx | New York | 10455 | United States |
| Sterling Research Group - Cincinnati / Mount Auburn | Cincinnati | Ohio | 45219 | United States |
| Insearch - Punzi Medical Center | Carrollton | Texas | 75006 | United States |
| ClinEdge - Dayton Clinical Research | Dayton | Texas | 45406-5144 | United States |
| Juno Research - Corporate Office | Houston | Texas | 77040 | United States |
| Insearch - R&H Clinical Research | Katy | Texas | 77450 | United States |
| Manassas Clinical Research Center | Manassas | Virginia | 20110 | United States |
| Fakultní nemocnice v Motole | Prague | 15006 | Czechia |
| Les Hôpitaux Universitaires de Strasbourg | Strasbourg | Grand Est | 67091 | France |
| Universitätsklinikum Schleswig-Holstein - Campus Kiel | Kiel | 24105 | Germany |
| Ambulatorium Barbara Bazela | Elblag | Żuławy | 82300 | Poland |
| Hospital Universitario de La Princesa | Madrid | 280006 | Spain |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 21, 2023 | Mar 17, 2023 | 3 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C528573 | firibastat |
Not provided
Not provided
Not provided