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

NCT07543120 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CQCZ484A12203B
• Study Type: interventional
• Target: 323
• Locations: 0 countries
• Sites: N/A

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)

Keywords

Hypertension; open-label extension study; QCZ484

Outcome Measures

Primary Outcomes (1)

• Number of participants with AEs

  Number of participants with Adverse events (AEs), including abnormal safety laboratory parameters and vital signs

  Up to 66 months

Secondary Outcomes (2)

• Change in SBP and DBP assessed by ambulatory blood pressure monitoring

  Baseline (parent study), Day 1 (OLE study) and up to month 60 (OLE study)

• Change in SBP and DBP assessed by office blood pressure measurement

  Baseline (parent study), Day 1 (OLE study) and up to month 66 (OLE study)

Study Arms (1)

QCZ484

EXPERIMENTAL

QCZ484 administered subcutaneously (SC) Q6M

Drug: QCZ484

Interventions

QCZ484 DRUG

QCZ484 subcutaneous injection, Q6M.

QCZ484

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Evidence of hepatic disease that would put participant at risk by taking QCZ484 for long term as determined by the Investigator.
• 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.
• Permanent or persistent atrial fibrillation developed during the parent study.
• Clinically significant valvular heart disease developed during the parent study.
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 21, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 31, 2031
• Study Completion (Estimated): November 30, 2031
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share