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

Launched by NOVARTIS PHARMACEUTICALS · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called QCZ484 for people with mild to moderate high blood pressure, also known as hypertension. The study aims to find the best dose of this medication and to see how well it works, how safe it is, and how well patients tolerate it. Participants will receive either QCZ484 or a placebo (a treatment that has no active ingredients) through an injection under the skin every six months.

To participate, individuals need to be between 18 and 75 years old, have a diagnosis of hypertension, and either not be on any blood pressure medications or be on a maximum of two. They must also be able to follow the study's procedures and give their consent to participate. People with certain medical conditions, like specific heart problems or those who have had recent serious heart events, won't be eligible for this trial. If you decide to take part, you can expect regular health check-ups and monitoring throughout the study to ensure your safety.

Gender

ALL

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:
• • 1. Known history of secondary hypertension.
• • 2. Orthostatic hypotension.
• • 3. Laboratory parameter assessments outside of range at screening.
• • 4. Evidence of hepatic disease.
• • 5. Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
• • 6. Any history of congestive heart failure.
• • 7. Current or history of intolerance to ACEi and/or ARBs.
• • 8. Clinically significant cardiac arrhythmias, high-grade AV block and third-degree AV block within 6 months prior to screening.
• • 9. Acute myocardial infarction (AMI) or unstable angina, or any percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within 12 months prior to screening. Any history of ischemic or hemorrhagic stroke or transient ischemic attack any time prior to screening.
• • Other protocol-defined inclusion/exclusion criteria may apply