Open Label Study of Treatment With LCZ696 in Hypertensive Patients With Renal Dysfunctio
Phase 3
- Conditions
- Hypertensive Patients With Renal Dysfunction
- Registration Number
- JPRN-jRCT2080221812
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 28
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 on renal failure
*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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of participants with reported adverse events ( total adverse events, serious adverse events and death)<br>Summerized report on adverse events such as number of patients with total adeverse events, serious adverse events and death will be reported.
- Secondary Outcome Measures
Name Time Method Change from baseline in mean sitting systolic blood pressure (msSBP) and mean sitting Diastolic Blood Pressure (msDBP) at week 8<br>Sitting BP measurements will be performed at screening through the end of study at every visit. Four separate sitting BP will be obtained with a full two-minute interval between measurements.<br>Percentage of patients achieving a successful BP control at week 8<br>A successful BP control is defined as msSBP <130 mmHg and msDBP <80 mmHg<br>Percentage of patients achieving a successful response rate in msSBP at week 8<br>Successful response rate is defined as msSBP <130 mmHg or a reduction of >=20 mmHg from baseline<br>Percentage of patients achieving a successful response rate in msDBP at week 8<br>Successful response rate is defined as msDBP <80 mmHg or a reduction of >=10 mmHg from baseline