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

NCT03198793 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2018-12-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

QGC001

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.

Sponsors & Collaborators

  • Quantum Genomics SA

    lead INDUSTRY

Principal Investigators

  • Keith C. Ferdinand, MD FACC · Tulane University SOM, New Orleans, LA 70112

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-13
Primary Completion
2018-10-16
Completion
2018-11-12

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03198793 on ClinicalTrials.gov