drugset / Trial / NCT03198793

Novel Evaluation With QGC001 in Hypertensive Overweight Patients of Multiple Ethnic Origins

NCT03198793

Phase 2 Completed 256 enrolled Quantum Genomics SA
NaSingle-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Firibastat Small molecule 250 mg Oral
Subject Firibastat Small molecule 500 mg Oral
Background Hydrochlorothiazide Unknown 25 mg