Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction
Hypertension With Renal Dysfunction
About this trial
This is an interventional treatment trial for Hypertension With Renal Dysfunction focused on measuring Hypertension, Renal dysfunction, LCZ696
Eligibility Criteria
Inclusion Criteria:
- Renal findings: Hypertensive patients with renal dysfunction and stable renal condition at least 4 weeks before screening visit.
- Satisfy office msSBP ≥140 mmHg and <180 mmHg at baseline.
Exclusion Criteria:
- Patients show msDBP ≥110 mmHg and/or msSBP ≥180 mmHg.
- History of angioedema, drug-related or otherwise, as reported by the patient.
- Any other following renal disorder:
- Patients show eGFR < 15mL/min/1.73m^2
- Patients on dialysis
- Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.
Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
LCZ696 100 mg
LCZ696 200 mg
LCZ696 400 mg
All participants were started on LCZ696 100 mg once daily on day 1.
All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.