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Active, not recruiting Phase 2

A Study to Identify an Optimal Dose of QCZ484 in Mild to Moderate Hypertensive Patients

NCT06857955 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2025-03-26
Last updated
2026-10-23

Condition(s) studied

Hypertension

Investigational drug(s) / intervention(s)

SalineQCZ484 →

Saline: 0.9% sodium chloride saline solution

QCZ484: Solution of Injection

Study summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of QCZ484 or placebo, given subcutaneously, every 6 months, at different dose levels in patients with mild to moderate hypertension

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Signed informed consent. 2. Males or females aged 18 to 75 years. 3. Diagnosis of hypertension. 4. Hypertension treatment naive or on maximum 2 anti-HTN medications and able to undergo washout for 4 weeks. 5. Mean sitting SBP ≥140 mmHg measured by OBPM and mean 24 hr SBP ≥130 mmHg and \<160 mmHg measured by ABPM. 6. Participants able to understand and comply with study procedures. Exclusion Criteria: 1. Known history of secondary hypertension. 2. Orthostatic hypotension. 3. Laboratory parameter assessments outside of range at screening. 4. Evidence of hepatic disease. 5. Medical condition, other than hypertension, requiring treatment with RAAS inhibitor. 6. Any history of congestive heart failure. 7. Current or history of intolerance to ACEi and/or ARBs. 8. Clinically significant cardiac arrhythmias, high-grade AV block and third-degree AV block within 6 months prior to screening. 9. Acute myocardial infarction (AMI) or unstable angina, or any percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within 12 months prior to screening. Any history of ischemic or hemorrhagic stroke or transient ischemic attack any time prior to screening. Other protocol-defined inclusion/exclusion criteria may apply

Primary outcome measure(s)

  • Change in Mean 24hr SBP by ABPM — Baseline, Month 3
    Change from baseline at Month 3 in mean 24hr systolic blood pressure (SBP) by ambulatory blood pressure measurement (ABPM)

Trial sites (72)

FacilityCityRegionStatus
SEC Clinical Research LLC Andalusia Alabama
Longwood Research Huntsville Alabama
The Center for Clinical Trials Saraland Alabama
Elite Clinical Studies Phoenix Arizona
Synexus Clinical Research US Inc Tucson Arizona
NICRs Research Center Garden Grove California
Valiance Clinical Research Huntington Park California
Downtown L A Research Center Inc Los Angeles California
Headlands Research Sacramento Sacramento California
Encompass Clinical Research Spring Valley California
Clinical Research of Brandon LLC Brandon Florida
ALL Medical Research LLC Cooper City Florida
National Research Institute Hialeah Florida
Cen Exel RCA Hollywood Florida
East Coast Institute for Research Jacksonville Florida
Entrust Clinical Research Miami Florida
Inpatient Research Clinical LLC Miami Lakes Florida
Renstar Medical Research Ocala Florida
American Research Centers of FL Pembroke Pines Florida
Cen Exel FCR Tampa Florida
Cardiology Partners Clinical Research Institute Wellington Florida
Centricity Research Columbus Georgia
Javara Research Fayetteville Georgia
Velocity Clinical Research Savannah Georgia
Solaris Clinical Research Meridian Idaho
Cedar Crosse Research Ct Chicago Illinois
Eagle Clinical Research Chicago Illinois
Synexus Clinical Research US Evansville Indiana
Velocity Clin Research Sioux City Sioux City Iowa
Alliance for Multispecialty Research Wichita Kansas
Velocity Clinical Res Baton Rouge Baton Rouge Louisiana
Southern Clin Research Clinic Zachary Louisiana
Ascension Saint Agnes Heart Care Baltimore Maryland
Anderson Medical Research Ft. Washington Maryland
Capitol Cardiology Associates Lanham Maryland
AA Medical Research Center Flint Michigan
Oakland Medical Research Center Troy Michigan
Synexus Clinical Research US Inc Richfield Minnesota
Healthcare Research Network II LLC Hazelwood Missouri
Jefferson City Medical Group Jefferson City Missouri

+ 32 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06857955 on ClinicalTrials.gov ↗ ← All trials in the USA