RecruitingPhase 2NCT06857955
A Study to Identify an Optimal Dose of QCZ484 in Mild to Moderate Hypertensive Patients
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
Sponsor
Novartis Pharmaceuticals
Enrollment
380 participants
Start Date
Mar 26, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria6
- Signed informed consent.
- Males or females aged 18 to 75 years.
- Diagnosis of hypertension.
- Hypertension treatment naive or on maximum 2 anti-HTN medications and able to undergo washout for 4 weeks.
- Mean sitting SBP ≥140 mmHg measured by OBPM and mean 24 hr SBP ≥130 mmHg and \<160 mmHg measured by ABPM.
- Participants able to understand and comply with study procedures.
Exclusion Criteria9
- Known history of secondary hypertension.
- Orthostatic hypotension.
- Laboratory parameter assessments outside of range at screening.
- Evidence of hepatic disease.
- Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
- Any history of congestive heart failure.
- Current or history of intolerance to ACEi and/or ARBs.
- Clinically significant cardiac arrhythmias, high-grade AV block and third-degree AV block within 6 months prior to screening.
- 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.
Interventions
OTHERSaline
0.9% sodium chloride saline solution
DRUGQCZ484
Solution of Injection
Locations(82)
View Full Details on ClinicalTrials.gov
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NCT06857955
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