Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT03198793
Status:
COMPLETED
Last Update Posted:
2018-12-11
First Post:
2017-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Novel Evaluation With QGC001 in Hypertensive Overweight Patients of Multiple Ethnic Origins
Sponsor:
Quantum Genomics SA
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEW-HOPE
Brief 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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: