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

Last Update: Dec 31, 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

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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

Apr 05, 2028

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:

Recruiting

Andalusia,Alabama,36420,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

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

SEC Clinical Research LLC

Donavon Wewers

Lauren Williams

Synexus Clinical Research US Inc

Heather Hickey

Judith Brown

NICRs Research Center

Mallu Reddy

Maria Murillo

Downtown L.A. Research Center Inc

Claudia Cisneros

Salil Nadkarni

Clinical Trials Research Sacramento

Jeffrey D Wayne

Leesa Koskela

Clinical Research of Brandon LLC

German Alvarez

Maylin Barrios

ALL Medical Research LLC

Craig Shapiro

Katherine Garcia

Alejandro Marin

Lorena Lewy-Alterbaum

Inpatient Research Clinical LLC

Alexis Gutierrez

Ana Laura Lopez

Jose Contreras

Sergio Ramirez

Entrust Clinical Research

Adolfo Cueli

Pablo Columbie

American Research Centers of FL

Liz Perez

Luis Del Prado Rodriguez

Cen Exel FCR

Deborah White

Kaylie Locascio

Cardiology Partners Clinical Research Institute

Hiromi Hauserman

Jean Foucauld

Javara Research

Frank N Cole

Kiara McFarland Head

Shemeka Williams

William Cooper

Solaris Clinical Research

David Butuk

Tricia Simon

Cedar Crosse Research Ct

Danny Hiroshi Sugimoto

Kareem Aburas

Eagle Clinical Research

Denniqua Scott

Olalekan Sowade

Synexus Clinical Research US

Melody Werne

Mohammed Allaw

Ascension Saint Agnes Heart Care

Jeffrey Cole

Morgan Beatty

Capitol Cardiology Associates

Iluyomade Adeusi

Vineet Venugopal

Oakland Medical Research Center

Jay Sandberg