Novel Evaluation With QGC001 in Hypertensive Overweight Patients of Multiple Ethnic Origins
Summary
Essential hypertension (HTN) is a disease that affects approximately 1 billion individuals worldwide. Despite the availability of effective and safe anti-hypertensive drugs, 65% of subjects diagnosed with HTN do not have their blood pressure (BP) controlled (\<140/90 mmHg). The overall incidence of resistant HTN, (defined as requiring 3 or more anti-hypertensive drugs, including a diuretic, to control BP) is estimated to be 15% of the hypertensive population. Consequently, there is a pressing unmet medical need to develop new classes of anti-hypertensive drugs that act on alternative pathways and further control BP and the associated cardiovascular risks in subjects. The prevalence of HTN in African Americans in the United States is among the highest in the world, and HTN is more common in African Americans than in Caucasians. One of the risk factors for HTN is sodium sensitivity. There is a higher association of HTN with sodium sensitivity in African American subjects and other racial/ethnic groups who are overweight/obese. Effective agents to treat HTN in this high-risk population are clearly needed. This study will be conducted in a hypertensive, overweight subject population of multiple ethnic origins in which QGC001 is likely, based on its mode of action, to demonstrate a significant anti-hypertensive effect.
Timeline
- Start
- 2017-10-13
- Primary completion
- 2018-10-16
- Completion
- 2018-11-12
Publications
- 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.
- Ferdinand KC, Harrison D, Johnson A. The NEW-HOPE study and emerging therapies for difficult-to-control and resistant hypertension. Prog Cardiovasc Dis. 2020 Jan-Feb;63(1):64-73. doi: 10.1016/j.pcad.2019.12.008. Epub 2020 Jan 8.
- Ferdinand KC, Balavoine F, Besse B, Black HR, Desbrandes S, Dittrich HC, Nesbitt SD. Efficacy and Safety of Firibastat, A First-in-Class Brain Aminopeptidase A Inhibitor, in Hypertensive Overweight Patients of Multiple Ethnic Origins. Circulation. 2019 Jul 9;140(2):138-146. doi: 10.1161/CIRCULATIONAHA.119.040070. Epub 2019 Apr 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Firibastat | Small molecule | 250 mg | Oral |
| Subject | Firibastat | Small molecule | 500 mg | Oral |
| Background | Hydrochlorothiazide | Unknown | 25 mg | — |