Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
PANORAMA-HF: Sacubitril/Valsartan vs Enalapril in Pediatric Heart Failure
NCT02678312Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2016
- Primary completion
- Jan 2022
- Countries
- 29
- Sponsor
- Novartis
- Modality
- Small Molecules
- Conditions
- heart failure (HF)
01
Overview
Phase 3, randomised, double-blind trial of sacubitril + valsartan in heart failure (HF) (3 arms), sponsored by Novartis. Primary endpoints: Global Ranking of Clinical Events at 52 weeks, Maximum Plasma Concentration at Day 1 and 3 more. Started Nov 2016; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Part 1: LCZ696
Open-label LCZ696 for PK/PD evaluation.
Part 2: LCZ696
LCZ696 (Sacubitril/Valsartan) bid.
Part 2: Enalapril
Enalapril bid (Active Control).
03
Who it enrols
Pediatric patients (1 month to <18 years) with chronic heart failure due to systemic left ventricular systolic dysfunction (LVEF <= 45% or fractional shortening <= 22.5%) and NYHA/Ross class II-IV. Patients must have biventricular physiology and be on stable HF therapy including ACEi/ARB.
04
Endpoints
Primary
Global Ranking of Clinical Events
Maximum Plasma Concentration
Area Under the Curve to Infinity
Change in Plasma B-type Natriuretic Peptide
Change in N-terminal Pro-brain Natriuretic Peptide
Secondary
Treatment Emergent Adverse Events
Change in NYHA/Ross Functional Class
Change in Patient Global Impression of Severity
Beyond the preview
Go deeper on NCT02678312.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT02678312.