Phase 3
Completed N=35
Safety and Tolerability and Efficacy of LCZ696 in Japanese Severe Hypertensive Patients
Severe Hypertension
Source: ClinicalTrials.gov NCT01646671 ↗
Enrolled (actual)
35
Serious AEs
1.6%
Results posted
Sep 2015
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events and Deaths — 20.0; 12.5; 33.3; 48.6 Percentage of participants
Summary
This study assessed the safety, tolerability, and efficacy of LCZ696 in severe hypertensive Japanese patients
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs), Serious Adverse Events and Deaths |
20.0; 12.5; 33.3; 48.6; 2.9; 0 | — |
| SECONDARY Change From Baseline in msSBP and msDBP at Week 8 |
-48.83; -30.34; -35.98; -35.31; -34.25; -16.98 | — |
| SECONDARY Percentage of Participants With Successful Blood Pressure (BP) Control in msSBP/msDBP at End of Study |
66.7; 18.2; 47.6; 40.0 | — |
| SECONDARY Percentage of Participants Achieving Successful msSBP Control at End of Study |
100; 45.5; 66.7; 62.9 | — |
| SECONDARY Percentage of Participants Achieving Successful msDBP Control at End of Study |
66.7; 36.4; 52.4; 48.6 | — |
| SECONDARY Percentage of Participants With SBP Response at End of Study |
100; 81.8; 85.7; 85.7 | — |
| SECONDARY Percentage of Participants With DBP Response at End of Study |
100; 100; 100; 100 | — |
Eligibility Criteria
Inclusion Criteria
- Satisfy office msSBP ≥180 mmHg or office msDBP ≥110 mmHg at baseline
Exclusion Criteria
- Patients show msSBP ≥220 mmHg and/or msDBP ≥120 mmHg
- History of angioedema, drug-related or otherwise, as reported by the patient
- Patients unwilling or not able to discontinue safely the use of current antihypertensive medications during the study, as required by the protocol.
- Patients have significant cardiovascular co-morbidities
- 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 (NCT01646671). 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. Informational only — not medical advice.