Hypertension
Conditions
Keywords
QCZ484, Hypertension
Brief summary
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
Detailed description
Phase 2b, multicenter, randomized, double-blind, placebo-controlled, 12 months treatment 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.
Interventions
OTHERSaline
0.9% sodium chloride saline solution
DRUGQCZ484
Solution of Injection
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean 24hr SBP by ABPM | Baseline, Month 3 | Change from baseline at Month 3 in mean 24hr systolic blood pressure (SBP) by ambulatory blood pressure measurement (ABPM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants achieving SBP<130 mmHg or SBP reduced by ≥10 mmHg by ABPM | Baseline, Month 3 and 6 | Proportion of responders defined as participants achieving SBP\<130 mmHg or SBP reduced by ≥10 mmHg from baseline, at Month 3 and 6 by ABPM |
| Change in DBP by ABPM and OBPM | Baseline, Month 3 and 6 | Change from baseline at Month 3 and 6 on diastolic blood pressure (DBP) by ABPM and OBPM |
| Number of participants with AEs | Up to Month 18 | Number of participants with AEs by treatment group, including changes in vital signs and laboratory results qualifying and reported as AEs. |
| Change in Mean 24hr SBP by ABPM | Baseline, Month 6 | Change from baseline at Month 6 in mean 24hr SBP by ABPM |
| Change in SBP by OBPM | Baseline, Month 3 and 6 | Change from baseline at Month 3 and 6 in SBP by office blood pressure measurement (OBPM) |
Countries
Japan, Singapore, United States
Outcome results
None listed