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

Last Update: Aug 13, 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:

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

Jefferson City Medical Group

George Carr

Suzin Cunningham

Manassas Clinical Research Center

Laura Reyes

Nabil Andrawis

Healthcare Research Network II LLC

Lyndsay Goeke

Larry Reed

Alliance for Multispecialty Resrch

Jerry Punch

Alexandra Hostetler

Suncoast Clinical Research

Sophia Falciani

Cathy Barnes

Encompass Clinical Research

Hanid Audish

Aracely Ramos

Centricity Research Suffolk Fam Med

Samir Abdelshaheed

Ashley Rice

Synergy Groups Medical LLC

July Tzoc

Deirdre McMullen

Sun Research Institute

Leonel Reyes

Melissa Martinez

Dominion Medical Associates

Richard A Jackson

Centricity Research

Zulfiquar Bhatti

Danesha Bankhead

Anderson Medical Research

Felton Anderson

Felton Anderson

MultiCare Ins Research Innovation

Vinay Malhotra

Trina Wesner

Velocity Clinical Research

Emilia Musial

Daniel Paul Williams Jr

Clinical Research Consultants LLC

Paula Dear

Ahmed M Awad

Clinical Neuroscience Solutions Inc

Lora J. McGill

Jason King

East Coast Institute for Research

James Sample Magee

Inayaa Johnson

Cen Exel RCA

Lorena Lewy-Alterbaum

Catherine Cruz

Craig Shapiro

Conrad Clinical Research

Willow Gravitt

Vicki Conrad

CenExel HRI

Michael Hassman

Justine Mackafee

Javara Research

Frank N Cole

Mary Willams

William Cooper

Cardiology Partners Clinical Research Institute

Jean Foucauld