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

Novartis

Status and phase: Enrolling; Phase 2

Conditions: Hypertension

Treatments: Drug: QCZ484; Other: Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT06857955

CQCZ484A12201

Details and patient eligibility

About

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

Full 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.

Enrollment: 380 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent.
2. Males or females aged 18 to 75 years.
3. Diagnosis of hypertension.
4. Hypertension treatment naive or on maximum 2 anti-HTN medications and able to undergo washout for 4 weeks.
5. Mean sitting SBP ≥140 mmHg measured by OBPM and mean 24 hr SBP ≥130 mmHg and <160 mmHg measured by ABPM.
6. Participants able to understand and comply with study procedures.

Exclusion criteria

1. Known history of secondary hypertension.
2. Orthostatic hypotension.
3. Laboratory parameter assessments outside of range at screening.
4. Evidence of hepatic disease.
5. Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
6. Any history of congestive heart failure.
7. Current or history of intolerance to ACEi and/or ARBs.
8. Clinically significant cardiac arrhythmias, high-grade AV block and third-degree AV block within 6 months prior to screening.
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.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

380 participants in 6 patient groups, including a placebo group

Placebo Control

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Saline

QCZ484 Dose 1

Experimental group

Description:

QCZ484 Dose 1 solution for injection

Treatment:

Drug: QCZ484

QCZ484 Dose 2

Experimental group

Description:

QCZ484 Dose 2 solution for injection

Treatment:

Drug: QCZ484

QCZ484 Dose 3

Experimental group

Description:

QCZ484 Dose 3 solution for injection

Treatment:

Drug: QCZ484

QCZ484 Dose 4

Experimental group

Description:

QCZ484 Dose 4 solution for injection

Treatment:

Drug: QCZ484

QCZ484 Dose 5

Experimental group

Description:

QCZ484 Dose 5 solution for injection

Treatment:

Drug: QCZ484