QCZ484 for High Blood Pressure

Recruiting at 30 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must not be taking: RAAS inhibitors, ACEi, ARBs

Disqualifiers: Secondary hypertension, Hepatic disease, CHF, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

380 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for adults with mild to moderate high blood pressure, either untreated or on up to two medications (which they can stop for 4 weeks). They need a specific range of blood pressure readings and must be able to understand and follow the study's procedures after giving informed consent.

Inclusion Criteria

I have signed the informed consent form.

My average blood pressure is high, both when sitting and over 24 hours.

I have high blood pressure and take no more than 2 medications for it, and can stop these medications for 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive QCZ484 or placebo subcutaneously every 6 months at different dose levels

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• QCZ484

Trial Overview The trial is testing QCZ484, a new medication given by injection every six months, against saline (a placebo). It aims to find the best dose by looking at how well it works and its safety in lowering blood pressure over time.

Participant Groups

Group I: QCZ484 Dose 5 Experimental Treatment 1 Intervention

QCZ484 Dose 5 solution for injection

Group II: QCZ484 Dose 4 Experimental Treatment 1 Intervention

QCZ484 Dose 4 solution for injection

Group III: QCZ484 Dose 3 Experimental Treatment 1 Intervention

QCZ484 Dose 3 solution for injection

Group IV: QCZ484 Dose 2 Experimental Treatment 1 Intervention

QCZ484 Dose 2 solution for injection

Group V: QCZ484 Dose 1 Experimental Treatment 1 Intervention

QCZ484 Dose 1 solution for injection

Group VI: Placebo Control Placebo Group 1 Intervention

Placebo

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

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD