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NCT07543120PHASE2Recruiting

An Open-label Extension Safety and Efficacy Study of QCZ484 in Hypertensive Patients.

Novartis Pharmaceuticals

Start Date

5/7/2026

Completion Date

11/30/2031

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.

Detailed Description

This is a single arm, multicenter, OLE study designed to evaluate long-term safety, tolerability and efficacy of QCZ484, administered SC, once Q6M, in patients with HTN, who have successfully completed treatment period in the parent studies of the QCZ484 HTN program. Participants at sites from the parent study will be offered the option to enroll in this extension study at the Month 12 visit upon successful completion of the parent study treatment.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

QCZ484

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Conditions

Hypertension (HTN)

Locations

NICRs Research Center

Garden Grove, California 92844

United States

Downtown L A Research Center Inc

Los Angeles, California 90017

United States

Clinical Research of Brandon LLC

Brandon, Florida 33511

United States

Entrust Clinical Research

Miami, Florida 33176

United States

Inpatient Research Clinical LLC

Miami Lakes, Florida 33014

United States

American Research Centers of FL

Pembroke Pines, Florida 33027

United States

Cen Exel FCR

Tampa, Florida 33613

United States

Cardiology Partners Clinical Research Institute

Wellington, Florida 33449

United States

Javara Research

Fayetteville, Georgia 30214

United States

Eagle Clinical Research

Chicago, Illinois 60621

United States

Alliance for Multispecialty Research

Wichita, Kansas 67207

United States

Anderson Medical Research

Ft. Washington, Maryland 20744

United States

Oakland Medical Research Center

Troy, Michigan 48085

United States

Jefferson City Medical Group

Jefferson City, Missouri 65109

United States

CenExel HRI

Berlin, New Jersey 08009

United States

Monroe Biomedical Research

Monroe, North Carolina 28112

United States

Conrad Clinical Research

Edmond, Oklahoma 73013

United States

Clinical Neuroscience Solutions Inc

Memphis, Tennessee 38119

United States

Sun Research Institute

San Antonio, Texas 78205

United States

Novartis Investigative Site

Suita, Osaka 5650853

Japan

Novartis Investigative Site

Chuo Ku, Tokyo 104-0031

Japan

Novartis Investigative Site

Chuo-ku, Tokyo 1030027

Japan

Novartis Investigative Site

Shinjuku Ku, Tokyo 160-0008

Japan

Novartis Investigative Site

Singapore, 119074

Singapore

Novartis Investigative Site

Singapore, 529889

Singapore