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

Purpose

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

Condition

  • Hypertension

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo Control 		Placebo
  • Other: Saline
    0.9% sodium chloride saline solution
Experimental
QCZ484 Dose 1 		QCZ484 Dose 1 solution for injection
  • Drug: QCZ484
    Solution of Injection
Experimental
QCZ484 Dose 2 		QCZ484 Dose 2 solution for injection
  • Drug: QCZ484
    Solution of Injection
Experimental
QCZ484 Dose 3 		QCZ484 Dose 3 solution for injection
  • Drug: QCZ484
    Solution of Injection
Experimental
QCZ484 Dose 4 		QCZ484 Dose 4 solution for injection
  • Drug: QCZ484
    Solution of Injection
Experimental
QCZ484 Dose 5 		QCZ484 Dose 5 solution for injection
  • Drug: QCZ484
    Solution of Injection

Recruiting Locations

UAB St Vincents
Birmingham 4049979, Alabama 4829764 35211
Contact:
Ashley Gilmore
+1 205 780 4330
agilmore@uabmc.edu

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

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

Detailed 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.