323 Participants NeededMy employer runs this trial

QCZ484 for High Blood Pressure

Recruiting at 23 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Novartis Pharmaceuticals
Must be taking: QCZ484
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

NP

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

Signed informed consent must be obtained prior to participation in the study
Successful completion of treatment period on QCZ484 study medication in parent study
No significant safety issue that may place participant at safety risk as determined by the Investigator

Exclusion Criteria

I do not have liver disease that would make this treatment unsafe for me.
I developed serious heart rhythm problems during the previous study.
I developed ongoing atrial fibrillation during the previous study.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Extension

Participants receive QCZ484 administered subcutaneously every 6 months

Up to 66 months
Visits every 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

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

Group I: QCZ484Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

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

A 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, ...

A 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 ...

A 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).