Novel Evaluation With QGC001 in Hypertensive Overweight Patients of Multiple Ethnic Origins (NEW-HOPE)
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|ClinicalTrials.gov Identifier: NCT03198793|
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : December 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: QGC001||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||256 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 13, 2017|
|Actual Primary Completion Date :||October 16, 2018|
|Actual Study Completion Date :||November 12, 2018|
Capsules of QGC001 250 mg
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]) over 8 weeks.
- Change in office systolic blood pressure from baseline to Week 8 (Day 56 Visit) [ Time Frame: 8 weeks ]Office blood pressure will be taken at Day 0, Visit 3, Visit 4, Visit 4.1, and Visit 5 (Day 56).
- Change in office diastolic blood pressure from baseline to Week 8 (Day 56 Visit) [ Time Frame: 8 weeks ]Office blood pressure will be taken at Day 0, Visit 3, Visit 4, Visit 4.1, and Visit 5 (Day 56).
- Change in office systolic blood pressure and diastolic blood pressure from baseline to Week 4 (Day 28 Visit) [ Time Frame: 4 weeks ]Office blood pressure will be taken at Day 0, Visit 3, Visit 4, Visit 4.1, and Visit 5 (Day 56).
- Change in mean 24-hour ambulatory systolic blood pressure, diastolic blood pressure, and mean office blood pressure from baseline to Week 8 (Day 56 Visit) [ Time Frame: 8 weeks ]Ambulatory blood pressure monitoring will be performed at Day 0 and Day 56.
- Percentage of responders (defined as subjects with normalized office blood pressure, ie, less than or equal to 140-90 mmHg at Week 8 - Day 56 Visit) [ Time Frame: 8 weeks ]Frequency and percentage of subjects who reach the level by the Week 8 (Day 56 Visit).
- Predictive factors for responders at Week 8 (Day 56 Visit) [ Time Frame: 8 weeks ]Identification of potential factors for responders, including baseline systolic blood pressure and diastolic blood pressure, gender, age, BMI, and others.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198793
|United States, Florida|
|Progressive Medical Research|
|Port Orange, Florida, United States, 32127|
|Study Chair:||Keith C. Ferdinand, MD FACC||Tulane University SOM, New Orleans, LA 70112|