Phase 2
Completed N=341
A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension
Source: ClinicalTrials.gov NCT01256411 ↗Enrolled (actual)
341
Serious AEs
1.9%
Results posted
Oct 2015
Primary outcomePrimary: Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) — 147; 78; 53; 0 Participants
Summary
The purpose of this study is to assess the long-term safety, tolerability and efficacy of LCZ696.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) |
147; 78; 53; 0; 6; 10 | — |
| SECONDARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment) |
-16.6; -14.2; -17.4; -16.8; -24.1; -21.3 | — |
| SECONDARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy) |
-15.7; -17.3; -23.0; -28.2 | — |
| SECONDARY Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment) |
114; 62; 77; 3 | — |
| SECONDARY Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy) |
176; 80 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who have successfully completed protocol No. CLCZ696A2219 and who, as judged by the study investigator, are able to continue in the current study.
- Ability to communicate and comply with all study requirements and demonstrate good medication compliance during CLCZ696A2219.
Exclusion Criteria
- Patients who did not complete CLCZ696A2219.
- Presence of significant protocol violation in CLCZ696A2219.
- Patients who are deemed to be unable to comply with the protocol by the investigator.
- Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01256411). 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.