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

Last Update: Jun 17, 2025

A Randomized, Double-blind, Placebo-controlled, Multicenter, 12 Months Treatment Duration, Dose Finding Study, to Evaluate Efficacy, Safety and Pharmacodynamics of QCZ484 in Mild to Moderate Hypertensive Patients

ClinicalTrials.gov Identifier:

NCT06857955

Novartis Reference Number:CQCZ484A12201

See if you Pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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 Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and pharmacodynamics of QCZ484 with mild to moderate hypertension (HTN). Multiple doses of QCZ484 will be tested against placebo, administered as subcutaneous injection.

Condition

Hypertension

Phase

Phase2

Overall Status

Recruiting

Number of Participants

380

Start Date

Mar 26, 2025

Completion Date

Dec 21, 2027

Gender

All

Age(s)

18 Years - 75 Years (Adult, Older Adult)

Interventions

Drug

QCZ484

Solution of Injection

Other

Saline

0.9% sodium chloride saline solution

Eligibility Criteria

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

Novartis Investigative Site

Recruiting

Singapore,519466,Singapore

Novartis Investigative Site

Recruiting

Singapore,119074,Singapore

Novartis Investigative Site

Recruiting

Singapore,529889,Singapore

Monroe Biomedical Research

Recruiting

Monroe,North Carolina,28112,United States

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

Study Description

Interventions

QCZ484

Saline

Eligibility Criteria

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Monroe Biomedical Research

Awawu Igbinadolor

Connor Lambert

Healthcare Research Network II LLC

Lyndsay Goeke

Larry Reed

Cen Exel RCA

Nelia Sanchez-Crespo

Pedro Petit Phar

Javara Research

Mary Willams

William Cooper

Frank N Cole

Capitol Cardiology Associates

Melissa Cruz

Vineet Venugopal

Encompass Clinical Research

Hanid Audish

Aracely Ramos

Downtown L.A. Research Center Inc

Daysi Aguilar

Salil Nadkarni

Synergy Groups Medical LLC

July Tzoc

Deirdre McMullen

American Research Centers of FL

Monica Elso

Luis Del Prado Rodriguez

SEC Clinical Research LLC

Donavon Wewers

Sydney Higgins

Eagle Clinical Research

Olalekan Sowade

Iesha Griffin

Dominion Medical Associates

Richard A Jackson

Jefferson City Medical Group

Christy Kidwell

George Carr

Suncoast Clinical Research

Cathy Barnes

Megan Casey

Sun Research Institute

Leonel Reyes

Melissa Mageno

Cen Exel FCR

Deborah White

Frances Encarnacion

Centricity Research Suffolk Fam Med

Quaneisha Tate

Samir Abdelshaheed

Synexus Clinical Research US

Abigail Hudson

Mohammed Allaw

Inpatient Research Clinical LLC

Alexis Gutierrez

Ariadna Mulet

Burke Primary Care

Stephen Keith Smith

Tara Tilson

Solaris Clinical Research

David Butuk

Melissa Conrad

Clinical Trials Research Sacramento

Alan Jazuli

Jeffrey D Wayne

Oakland Medical Research Center

Jay Sandberg

Julieanna Sherrod

Synexus Clinical Research US Inc

Heather Hickey