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

Active Not RecruitingPhase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Hypertension

Interventions: Saline, QCZ484

Countries: United States, Japan, Singapore

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (73)

Andalusia, Alabama, United States
Huntsville, Alabama, United States
Saraland, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Garden Grove, California, United States
Huntington Park, California, United States
Los Angeles, California, United States
Sacramento, California, United States
Spring Valley, California, United States
Brandon, Florida, United States
Cooper City, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Ocala, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
Wellington, Florida, United States
Columbus, Georgia, United States
Fayetteville, Georgia, United States
Savannah, Georgia, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Evansville, Indiana, United States
Sioux City, Iowa, United States
Wichita, Kansas, United States
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