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RecruitingPhase 2NCT06857955

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

Trial Parameters

ConditionHypertension
SponsorNovartis Pharmaceuticals
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment380
SexALL
Min Age18 Years
Max Age75 Years
Start Date2025-03-26
Completion2027-01-29
Interventions
SalineQCZ484

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Brief 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 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 corona

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