Phase 2 N=341 Treatment

A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension

Essential Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01256411 ↗

Enrolled (actual)

341

Serious AEs

1.9%

Results posted

Oct 2015

Primary outcome: Primary: Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) — 147; 78; 53; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LCZ696 (Drug); Amlodipine (Drug); Hydrochlorothiazide (HCTZ) (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Apr 2012

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	—

Summary

The purpose of this study is to assess the long-term safety, tolerability and efficacy of LCZ696.

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

View full record on ClinicalTrials.gov →

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.