Phase 3
N=32
Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction
Hypertension With Renal Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01593787 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death) — 31.3; 0; 27.8; 43.8 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- LCZ696 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death) |
31.3; 0; 27.8; 43.8; 0; 0 | — |
| SECONDARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8 |
-19.71; -27.19; -17.79; -20.50 | — |
| SECONDARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8 |
-7.17; -9.94; -7.99; -8.32 | — |
| SECONDARY Percentage of Participants Achieving a Successful BP Control at Week 8 |
66.7; 37.5; 5.6; 25.0 | — |
| SECONDARY Percentage of Participants Achieving SBP Control at Week 8 |
66.7; 50.0; 44.4; 50.0 | — |
| SECONDARY Percentage of Participants Achieving DBP Control at Week 8 |
83.3; 62.5; 27.8; 46.9 | — |
| SECONDARY Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8 |
66.7; 75.0; 50.0; 59.4 | — |
| SECONDARY Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8 |
83.3; 87.5; 61.1; 71.9 | — |
Summary
This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction.
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.
Data sourced from ClinicalTrials.gov (NCT01593787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.