Hypertension Clinical Trial
Official title:
A Phase 2, Open-Label, Dose-Titrating Safety and Efficacy Study of QGC001 Administered Orally, Twice Daily, Over 8 Weeks in Hypertensive Overweight Subjects of Multiple Ethnic and Racial Groups in the United States
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.
QGC001 is a prodrug of the specific and selective APA inhibitor, EC33, and is the prototype
of a new class of centrally-acting anti-hypertensive agents called brain APA inhibitors.
Inhibition of brain APA, which converts Ang II into Ang III, has emerged as a novel anti
hypertensive treatment, as demonstrated in several experimental animal models. QGC001's
anti-hypertensive effect is in part due to: 1) a decrease in arginine vasopressin release in
the blood circulation, increasing diuresis, which reduces the size of body fluid compartment;
and 2) a reduction in the sympathetic tone, leading to subsequent decreases in vascular
resistances.
This study is an open-label, dose-titrating safety and efficacy study of QGC001 administered
PO, BID, over 8 weeks in hypertensive overweight subjects of multiple ethnic and racial
groups in the United States.
The primary objective of this study is to assess the effects of twice daily (BID)
administration of oral (PO) QGC001 (250 mg BID, 500 mg BID, and 500 mg BID +
hydrochlorothiazide (HCTZ) 25 mg once daily [QD]) on blood pressure (BP) over 8 weeks in
hypertensive overweight/obese subjects of multiple races/ethnicities.
;
| 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 |