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Long-term study of LCZ696 treatment in patients with essential hypertension

An open-label, long-term extension study to evaluate the safety, tolerability and efficacy of 12 months of LCZ696 treatment in patients with essential hypertension

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221787
Enrollment
344
Registered
2012-05-14
Start date
2012-05-14
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

Essential hypertension

Interventions

Sponsors

Novartis Pharma K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients that have successfully completed Core study (JapicCTI-101273) and who, as judged by the investigator, are able to continue in the open-label extension. 2. Ability to communicate and comply with all study requirements and demonstrate good medication compliance (>=80% compliance rate) during Core study.

Exclusion criteria

Exclusion criteria: 1. Patients who did not complete Core study. 2. Presence of significant protocol violation in Core study. 3. Patients who are deemed to be unable to comply with the protocol by the investigator.

Design outcomes

Primary

MeasureTime frame
Safety and tolerability The primary assessment for safety and tolerability is the reporting of any adverse events and serious adverse events (SAE) including death.

Secondary

MeasureTime frame
Mean sitting diastolic blood pressure and mean sitting systolic blood pressure Summary statistics for the post-baseline and the change-from-baseline measurements will be provided by timepoint in mean sitting diastolic blood pressure, mean sitting systolic blood pressure.

Outcome results

None listed

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