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
Novartis Pharmaceuticals
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
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- 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.…
Interventions
- OtherSaline
0.9% sodium chloride saline solution
- DrugQCZ484
Solution of Injection
Locations (84)
- SEC Clinical Research LLCAndalusia, Alabama
- UAB St VincentsBirmingham, Alabama
- Longwood ResearchHuntsville, Alabama
- The Center for Clinical TrialsSaraland, Alabama
- Elite Clinical StudiesPhoenix, Arizona
- Synexus Clinical Research US IncTucson, Arizona