Open Label Study of Treatment With LCZ696 in Hypertensive Patients With Renal Dysfunction

A Multi-center, Open Label Study for Evaluation of the Safety, Tolerability and Efficacy of 8-week Treatment With LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221812

Enrollment

Registered

2012-05-25

Start date

2012-05-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertensive Patients With Renal Dysfunction

Interventions

investigational material(s) Generic name etc : LCZ696 INN of investigational material : Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigational material : Once

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Number of participants with reported adverse events ( total adverse events, serious adverse events and death) Summerized report on adverse events such as number of patients with total adeverse events, serious adverse events and death will be reported.	—

Secondary

Measure	Time frame
Change from baseline in mean sitting systolic blood pressure (msSBP) and mean sitting Diastolic Blood Pressure (msDBP) at week 8 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. Percentage of patients achieving a successful BP control at week 8 A successful BP control is defined as msSBP =20 mmHg from baseline Percentage of patients achieving a successful response rate in msDBP at week 8 Successful response rate is defined as msDBP =10 mmHg from baseline	—

Measure

Time frame

Change from baseline in mean sitting systolic blood pressure (msSBP) and mean sitting Diastolic Blood Pressure (msDBP) at week 8 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. Percentage of patients achieving a successful BP control at week 8 A successful BP control is defined as msSBP =20 mmHg from baseline Percentage of patients achieving a successful response rate in msDBP at week 8 Successful response rate is defined as msDBP =10 mmHg from baseline

—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026