A Study to Identify an Optimal Dose of QCZ484 in Mild to Moderate Hypertensive Patients
- Registration Number
- NCT06857955
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 380
- 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.
- 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.
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Control Saline Placebo QCZ484 Dose 1 QCZ484 QCZ484 Dose 1 solution for injection QCZ484 Dose 2 QCZ484 QCZ484 Dose 2 solution for injection QCZ484 Dose 3 QCZ484 QCZ484 Dose 3 solution for injection QCZ484 Dose 4 QCZ484 QCZ484 Dose 4 solution for injection QCZ484 Dose 5 QCZ484 QCZ484 Dose 5 solution for injection
- Primary Outcome Measures
Name Time Method Change in Mean 24hr SBP by ABPM Baseline, Month 3 Change from baseline at Month 3 in mean 24hr systolic blood pressure (SBP) by ambulatory blood pressure measurement (ABPM)
- Secondary Outcome Measures
Name Time Method Change in Mean 24hr SBP by ABPM Baseline, Month 6 Change from baseline at Month 6 in mean 24hr SBP by ABPM
Change in SBP by OBPM Baseline, Month 3 and 6 Change from baseline at Month 3 and 6 in SBP by office blood pressure measurement (OBPM)
Change in DBP by ABPM and OBPM Baseline, Month 3 and 6 Change from baseline at Month 3 and 6 on diastolic blood pressure (DBP) by ABPM and OBPM
Participants achieving SBP<130 mmHg or SBP reduced by ≥10 mmHg by ABPM Baseline, Month 3 and 6 Proportion of responders defined as participants achieving SBP\<130 mmHg or SBP reduced by ≥10 mmHg from baseline, at Month 3 and 6 by ABPM
Number of participants with AEs Up to Month 18 Number of participants with AEs by treatment group, including changes in vital signs and laboratory results qualifying and reported as AEs.
Related Research Topics
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Trial Locations
- Locations (30)
SEC Clinical Research LLC
🇺🇸Andalusia, Alabama, United States
Synexus Clinical Research US Inc
🇺🇸Richfield, Minnesota, United States
NICRs Research Center
🇺🇸Garden Grove, California, United States
Downtown L.A. Research Center Inc
🇺🇸Los Angeles, California, United States
Clinical Trials Research Sacramento
🇺🇸Sacramento, California, United States
Clinical Research of Brandon LLC
🇺🇸Brandon, Florida, United States
Cen Exel RCA
🇺🇸Hollywood, Florida, United States
Inpatient Research Clinical LLC
🇺🇸Miami Lakes, Florida, United States
Entrust Clinical Research
🇺🇸Miami, Florida, United States
American Research Centers of FL
🇺🇸Pembroke Pines, Florida, United States
Cen Exel FCR
🇺🇸Tampa, Florida, United States
Cardiology Partners Clinical Research Institute
🇺🇸Wellington, Florida, United States
Javara Research
🇺🇸Fayetteville, Georgia, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
Cedar Crosse Research Ct
🇺🇸Chicago, Illinois, United States
Eagle Clinical Research
🇺🇸Chicago, Illinois, United States
Synexus Clinical Research US
🇺🇸Evansville, Indiana, United States
Ascension Saint Agnes Heart Care
🇺🇸Baltimore, Maryland, United States
Anderson Medical Research
🇺🇸Fort Washington, Maryland, United States
Capitol Cardiology Associates
🇺🇸Lanham, Maryland, United States
Oakland Medical Research Center
🇺🇸Troy, Michigan, United States
Monroe Biomedical Research
🇺🇸Monroe, North Carolina, United States
Burke Primary Care
🇺🇸Morganton, North Carolina, United States
North Hills Medical Research Inc
🇺🇸Bedford, Texas, United States
Synergy Groups Medical LLC
🇺🇸Missouri City, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
Dominion Medical Associates
🇺🇸Richmond, Virginia, United States
Centricity Research Suffolk Fam Med
🇺🇸Suffolk, Virginia, United States
Novartis Investigative Site
🇸🇬Singapore, Singapore