RECRUITING

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

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Conditions

HypertensionQCZ484

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2025-03-26
Study Completion:2027-12-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06857955

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Signed informed consent.
  2. 2. Males or females aged 18 to 75 years.
  3. 3. Diagnosis of hypertension.
  4. 4. Hypertension treatment naive or on maximum 2 anti-HTN medications and able to undergo washout for 4 weeks.
  5. 5. Mean sitting SBP ≥140 mmHg measured by OBPM and mean 24 hr SBP ≥130 mmHg and \<160 mmHg measured by ABPM.
  6. 6. Participants able to understand and comply with study procedures.
  1. 1. Known history of secondary hypertension.
  2. 2. Orthostatic hypotension.
  3. 3. Laboratory parameter assessments outside of range at screening.
  4. 4. Evidence of hepatic disease.
  5. 5. Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
  6. 6. Any history of congestive heart failure.
  7. 7. Current or history of intolerance to ACEi and/or ARBs.
  8. 8. Clinically significant cardiac arrhythmias, high-grade AV block and third-degree AV block within 6 months prior to screening.
  9. 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.

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111

Study Locations (Sites)

SEC Clinical Research LLC
Andalusia, Alabama, 36420
United States
Synexus Clinical Research US Inc
Tucson, Arizona, 85741
United States
NICRs Research Center
Garden Grove, California, 92844
United States
Downtown L.A. Research Center Inc
Los Angeles, California, 90017
United States
Clinical Trials Research Sacramento
Sacramento, California, 95821-2134
United States
Clinical Research of Brandon LLC
Brandon, Florida, 33511
United States
Cen Exel RCA
Hollywood, Florida, 33024
United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014
United States
Entrust Clinical Research
Miami, Florida, 33176
United States
American Research Centers of FL
Pembroke Pines, Florida, 33027
United States
Cen Exel FCR
Tampa, Florida, 33613
United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, 33449
United States
Javara Research
Fayetteville, Georgia, 30214
United States
Javara Research
Fayetteville, Georgia, 30214
United States
Solaris Clinical Research
Meridian, Idaho, 83646
United States
Cedar Crosse Research Ct
Chicago, Illinois, 60607
United States
Eagle Clinical Research
Chicago, Illinois, 60621
United States
Synexus Clinical Research US
Evansville, Indiana, 47714
United States
Ascension Saint Agnes Heart Care
Baltimore, Maryland, 21229
United States
Anderson Medical Research
Fort Washington, Maryland, 20744
United States
Capitol Cardiology Associates
Lanham, Maryland, 20706
United States
Oakland Medical Research Center
Troy, Michigan, 48085
United States
Synexus Clinical Research US Inc
Richfield, Minnesota, 55432
United States
Monroe Biomedical Research
Monroe, North Carolina, 28112
United States
Burke Primary Care
Morganton, North Carolina, 28655
United States
North Hills Medical Research Inc
Bedford, Texas, 76021
United States
Synergy Groups Medical LLC
Missouri City, Texas, 77459
United States
Sun Research Institute
San Antonio, Texas, 78205
United States
Manassas Clinical Research Center
Manassas, Virginia, 20110
United States
Dominion Medical Associates
Richmond, Virginia, 23219
United States
Centricity Research Suffolk Fam Med
Suffolk, Virginia, 23434
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-26
Study Completion Date2027-12-21

Study Record Updates

Study Start Date2025-03-26
Study Completion Date2027-12-21

Terms related to this study

Keywords Provided by Researchers

  • QCZ484
  • Hypertension

Additional Relevant MeSH Terms

  • Hypertension