Clinical trial NCT06857955: A Study to Identify an Optimal Dose of QCZ484 in Mild to Moderate Hypertensive Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hypertension
Keywords: QCZ484
Hypertension
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-03-05
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Detailed description: Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and pharmacodynamics of QCZ484 with mild to moderate hypertension (HTN). Multiple doses of QCZ484 will be tested against placebo, administered as subcutaneous injection.

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

Primary outcomes:
measure: Change in Mean 24hr SBP by ABPM
timeFrame: Baseline, Month 3
Secondary outcomes:
measure: Change in Mean 24hr SBP by ABPM
timeFrame: Baseline, Month 6
measure: Change in SBP by OBPM
timeFrame: Baseline, Month 3 and 6
measure: Participants achieving SBP<130 mmHg or SBP reduced by ≥10 mmHg by ABPM
timeFrame: Baseline, Month 3 and 6
measure: Change in DBP by ABPM and OBPM
timeFrame: Baseline, Month 3 and 6
measure: Number of participants with AEs
timeFrame: Up to Month 18
Other outcomes:
Locations:
city: Andalusia
country: United States
facility: SEC Clinical Research LLC
state: Alabama
city: Tucson
country: United States
facility: Synexus Clinical Research US Inc
state: Arizona
city: Garden Grove
country: United States
facility: NICRs Research Center
state: California
city: Los Angeles
country: United States
facility: Downtown L.A. Research Center Inc
state: California
city: Sacramento
country: United States
facility: Clinical Trials Research Sacramento
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Brandon
country: United States
facility: Clinical Research of Brandon LLC
state: Florida
city: Hollywood
country: United States
facility: Cen Exel RCA
state: Florida
city: Miami Lakes
country: United States
facility: Inpatient Research Clinical LLC
state: Florida
city: Miami
country: United States
facility: Entrust Clinical Research
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Pembroke Pines
country: United States
facility: American Research Centers of FL
state: Florida
city: Tampa
country: United States
facility: Cen Exel FCR
state: Florida
city: Wellington
country: United States
facility: Cardiology Partners Clinical Research Institute
state: Florida
city: Fayetteville
country: United States
facility: Javara Research
state: Georgia
city: Fayetteville
country: United States
facility: Javara Research
state: Georgia
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Cedar Crosse Research Ct
state: Illinois
city: Chicago
country: United States
facility: Eagle Clinical Research
state: Illinois
city: Evansville
country: United States
facility: Synexus Clinical Research US
state: Indiana
city: Wichita
country: United States
facility: Alliance for Multispecialty Resrch
state: Kansas
city: Baltimore
country: United States
facility: Ascension Saint Agnes Heart Care
state: Maryland
city: Fort Washington
country: United States
facility: Anderson Medical Research
state: Maryland
city: Lanham
country: United States
facility: Capitol Cardiology Associates
state: Maryland
city: Troy
country: United States
facility: Oakland Medical Research Center
state: Michigan
city: Richfield
country: United States
facility: Synexus Clinical Research US Inc
state: Minnesota
city: Hazelwood
country: United States
facility: Healthcare Research Network II LLC
state: Missouri
city: Jefferson City
country: United States
facility: Jefferson City Medical Group
state: Missouri
city: Berlin
country: United States
facility: CenExel HRI
state: New Jersey
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Morganton
country: United States
facility: Burke Primary Care
state: North Carolina
city: Edmond
country: United States
facility: Conrad Clinical Research
state: Oklahoma
city: Bedford
country: United States
facility: North Hills Medical Research Inc
state: Texas
city: Missouri City
country: United States
facility: Synergy Groups Medical LLC
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Richmond
country: United States
facility: Dominion Medical Associates
state: Virginia
city: Suffolk
country: United States
facility: Centricity Research Suffolk Fam Med
state: Virginia
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
Study officials:
References: