Recruiting
Phase 2

QCZ484

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07543120

Conditions

Hypertension (HTN)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

QCZ484

Study Details

Brief summary:

The purpose of this extension study is to collect additional safety and efficacy on QCZ484 for hypertensive patients who successfully completed the parent study, CQCZ484A12201 or additional QCZ484 studies as specified in the respective parent study protocols.

Conditions

Hypertension (HTN)

Study ID

NCT07543120

Start date

May 7, 2026

Status verified date

Jul, 2026

Completion date

Nov 30, 2031

Anticipated

Primary completion date

May 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study.
2. Successful completion of treatment period on QCZ484 study medication in parent study.
3. No significant safety issue that may place participant at safety risk as determined by the Investigator.

Exclusion Criteria:

Participants meeting any of the following criteria, may it be pre-existing or developed during the parent study, are not eligible for inclusion in this study:

1. Evidence of hepatic disease that would put participant at risk by taking QCZ484 for long term as determined by the Investigator.
2. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), high-grade atrioventricular (AV) block (e.g., Mobitz type II and third-degree AV block in absence of a pacemaker) developed during the parent study.
3. Permanent or persistent atrial fibrillation developed during the parent study.
4. Clinically significant valvular heart disease developed during the parent study.
5. Acute myocardial infarction (AMI) or unstable angina, or any percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) developed during the parent study. Any history of ischemic or hemorrhagic stroke or transient ischemic attack any time prior to enrollment.

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Enrollment

323 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: QCZ484

QCZ484 administered subcutaneously (SC) Q6M

Interventions

QCZ484

QCZ484 subcutaneous injection, Q6M.

Primary outcome measure

  • Number of participants with AEs [ Time Frame: Up to 66 months ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

+41613241111

Locations

NICRs Research Center

Recruiting

Garden Grove, California, United States, 92844

Contacts

Principal Investigator:

Mallu Reddy

Downtown L A Research Center Inc

Recruiting

Los Angeles, California, United States, 90017

Contacts

Principal Investigator:

Salil U Nadkarni

Clinical Research of Brandon LLC

Recruiting

Brandon, Florida, United States, 33511

Contacts

Erika Santos

esantos@crofb.com

Principal Investigator:

German Alvarez

Entrust Clinical Research

Recruiting

Miami, Florida, United States, 33176

Contacts

Principal Investigator:

Adolfo Cueli

Inpatient Research Clinical LLC

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

Principal Investigator:

Alexis Gutierrez

American Research Centers of FL

Recruiting

Pembroke Pines, Florida, United States, 33027

Contacts

Principal Investigator:

Luis Del Prado Rodriguez

Cen Exel FCR

Recruiting

Tampa, Florida, United States, 33613

Contacts

Kaylie Locascio

k.locascio@cenexel.com

Principal Investigator:

Deborah White

Cardiology Partners Clinical Research Institute

Recruiting

Wellington, Florida, United States, 33449

Contacts

Principal Investigator:

Neerav Suresh Shah

Javara Research

Recruiting

Fayetteville, Georgia, United States, 30214

Contacts

Principal Investigator:

William Cooper

Eagle Clinical Research

Recruiting

Chicago, Illinois, United States, 60621

Contacts

Principal Investigator:

Olalekan Sowade

Alliance for Multispecialty Research

Recruiting

Wichita, Kansas, United States, 67207

Contacts

Principal Investigator:

Jerry Punch

Anderson Medical Research

Recruiting

Ft. Washington, Maryland, United States, 20744

Contacts

Principal Investigator:

Felton Anderson

Oakland Medical Research Center

Recruiting

Troy, Michigan, United States, 48085

Contacts

Principal Investigator:

Jay Sandberg

Jefferson City Medical Group

Recruiting

Jefferson City, Missouri, United States, 65109

Contacts

Principal Investigator:

George Carr

CenExel HRI

Recruiting

Berlin, New Jersey, United States, 08009

Contacts

Principal Investigator:

Kyle Coupe

Monroe Biomedical Research

Recruiting

Monroe, North Carolina, United States, 28112

Contacts

Principal Investigator:

Awawu Igbinadolor

Conrad Clinical Research

Recruiting

Edmond, Oklahoma, United States, 73013

Contacts

Principal Investigator:

Vicki Conrad

Clinical Neuroscience Solutions Inc

Recruiting

Memphis, Tennessee, United States, 38119

Contacts

Principal Investigator:

Lora J. McGill

Sun Research Institute

Recruiting

San Antonio, Texas, United States, 78205

Contacts

Chandana Gagireddy

cgagireddy@sunresearch.com

Principal Investigator:

Leonel Reyes

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • Hypertension
  • open-label extension study
  • QCZ484

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-30.