Phase 2 N=498 Randomized Quadruple-blind Treatment

Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients

Heart Failure With Reduced Ejection Fraction

Bottom Line

View on ClinicalTrials.gov: NCT01922089 ↗

Enrolled (actual)

498

Serious AEs

7.0%

Results posted

Oct 2015

Primary outcome: Primary: Number of Participants Experiencing Hypotension, Renal Dysfunction, Hyperkalemia and Angioedema and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low) — 5; 7; 19; 14 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LCZ696 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Aug 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Experiencing Hypotension, Renal Dysfunction, Hyperkalemia and Angioedema and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low)	5; 7; 19; 14; 24; 21	—
SECONDARY Number of Participants Who Achieved Treatment Success Over the 12 Weeks and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low)	90; 98; 89; 101; 179; 199	—
SECONDARY Number of Participants Who Tolerated Study Medication for at Least the Last Two Weeks of the Study and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low).	94; 103; 97; 103; 191; 206	—

Summary

The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.

Eligibility Criteria

Inclusion Criteria

Age ≥ 18 years; CHF with New York Heart Association class II-IV; left ventricular ejection fraction ≤ 35%; on beta blockers

Exclusion Criteria

Potassium > 5.2 mmol/l; estimated glomerular filtration rate 180 mmHg; history of intolerance to recommended target doses of angiotensin converting enzyme inhibitors or angiotensin receptor blockers

Other protocol-defined inclusion/exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01922089). 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.