QCZ484 for High Blood Pressure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a treatment called QCZ484 for individuals with high blood pressure. The goal is to gather more information on the safety and effectiveness of QCZ484 for those who completed a previous study with it. This trial suits individuals who finished the earlier study without major safety concerns. Participants should not have developed severe heart issues or liver problems during the earlier study. The trial aims to ensure QCZ484 is safe for long-term use in managing high blood pressure. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the QCZ484 trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that QCZ484 is likely to be safe for humans?
Research has shown that QCZ484 underwent safety testing in earlier studies. These studies administered different doses of QCZ484 to both healthy individuals and those with mild high blood pressure. The treatment involved an injection under the skin every six months. Researchers analyzed blood and urine samples to identify any safety concerns.
QCZ484 was generally well-tolerated, with participants rarely experiencing severe side effects. Some mild side effects were reported, such as reactions at the injection site or minor changes in lab results. Overall, the data collected so far suggests the treatment is safe.12345Why do researchers think this study treatment might be promising for high blood pressure?
Unlike the standard treatments for high blood pressure, which often include oral medications like ACE inhibitors, beta-blockers, or diuretics, QCZ484 is administered subcutaneously every six months. This long-acting method could offer convenience and improve adherence for patients who struggle with daily pills. Researchers are excited because QCZ484 might provide more consistent blood pressure control with fewer fluctuations, potentially reducing the risk of complications associated with high blood pressure.
What evidence suggests that QCZ484 might be an effective treatment for high blood pressure?
Research has shown that QCZ484 might help lower high blood pressure in people with mild to moderate hypertension. In earlier studies, participants who received QCZ484 experienced lower blood pressure compared to those who received a placebo, a harmless pill with no active medicine. In this trial, participants will receive QCZ484 as an injection under the skin every six months. Researchers have tested its safety and tolerability. These findings suggest that QCZ484 could be a promising option for managing high blood pressure.12567
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for people with high blood pressure who have already finished a previous study using QCZ484 and had no major safety problems. Participants must give consent and be considered safe to continue by the study doctor.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Open-label Extension
Participants receive QCZ484 administered subcutaneously every 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- QCZ484
Trial Overview
The study is testing the long-term safety and effectiveness of QCZ484, a medication for high blood pressure, in patients who previously took part in related studies. All participants will receive QCZ484.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
QCZ484 administered subcutaneously (SC) Q6M
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD
Citations
NCT06857955 | A Study to Identify an Optimal Dose of ...
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 ...
QCZ484 for High Blood Pressure · Info for Participants
Research has shown that QCZ484 might help lower high blood pressure. In earlier studies, QCZ484 reduced blood pressure in people with mild to moderate ...
The First Hypertension Trial Comparing the Effects of Two ...
The most current recommendations now suggest that blood pressure levels recently labeled “normal at reducing CVD morbidity and mortality compared with placebo
4.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-evaluate-the-safety-of-qcz484-in-healthy-and-mild-hypertensive-subjectsA Study to Evaluate the Safety of QCZ484 in Healthy and Mild ...
This is a randomized, double-blind, placebo-controlled study including Part A single ascending dose (SAD) in healthy subjects and Part B single ...
Study Details | NCT07543120 | An Open-label Extension ...
Efficacy Study of QCZ484 in Hypertensive Patients. a certification can delay results submission up to 2 years. Also called a data safety and monitoring board, ...
6.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-identify-an-optimal-dose-of-qcz484-in-mild-to-moderate-hypertensive-patientsA Study to Identify an Optimal Dose of QCZ484 in Mild to ...
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 ...
7.
trial.medpath.com
trial.medpath.com/clinical-trial/ca62d7cc2c0ebbf9/nct06905327-qcz484-safety-tolerability-hypertensionA Study to Evaluate the Safety of QCZ484... | Clinical Trial
Safety laboratory data (blood chemistry, hematology, coagulation, and urinalysis). Secondary Outcomes. Number of AEs(up to 48 weeks post dose).
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