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

Description

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

Conditions

Hypertension

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Study Overview

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Study Details

Study overview

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

A Randomized, Double-blind, Placebo-controlled, Multicenter, 12 Months Treatment Duration, Dose Finding Study, to Evaluate Efficacy, Safety and Pharmacodynamics of QCZ484 in Mild to Moderate Hypertensive Patients

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

Condition
Hypertension
Intervention / Treatment

-

Contacts and Locations

Andalusia

SEC Clinical Research LLC, Andalusia, Alabama, United States, 36420

Tucson

Synexus Clinical Research US Inc, Tucson, Arizona, United States, 85741

Garden Grove

NICRs Research Center, Garden Grove, California, United States, 92844

Los Angeles

Downtown L.A. Research Center Inc, Los Angeles, California, United States, 90017

Sacramento

Clinical Trials Research Sacramento, Sacramento, California, United States, 95821-2134

Brandon

Clinical Research of Brandon LLC, Brandon, Florida, United States, 33511

Hollywood

Cen Exel RCA, Hollywood, Florida, United States, 33024

Miami Lakes

Inpatient Research Clinical LLC, Miami Lakes, Florida, United States, 33014

Miami

Entrust Clinical Research, Miami, Florida, United States, 33176

Pembroke Pines

American Research Centers of FL, Pembroke Pines, Florida, United States, 33027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Study Record Dates

2027-12-21