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Angiotensin Receptor Neprilysin Inhibitor

Long-term Safety of Sacubitril/Valsartan for Heart Failure

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4.5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial looks at the long-term safety and tolerability of a heart failure drug.

Who is the study for?
This trial is for pediatric patients with heart failure who were previously on the PANORAMA-HF study drug at the end of its second part and had no significant safety issues. It excludes those with certain allergies, renal or hepatic disorders, a history of angioedema, or who used other investigational drugs recently.
What is being tested?
The trial is testing sacubitril/valsartan's long-term safety in children with heart failure. Participants will receive this medication openly to gather extended safety and tolerability data following their involvement in the PANORAMA-HF study.
What are the potential side effects?
Potential side effects may include allergic reactions, changes in kidney function, liver enzyme elevations, digestive disturbances, and possible swelling under the skin (angioedema), similar to what adults might experience.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Duration of Drug Exposure
Number of Participants With Adverse Events
Number of Participants With Serious Adverse Events

Side effects data

From 2019 Phase 3 trial • 2572 Patients • NCT03066804
12%
Glomerular filtration rate decreased
11%
Hyperkalaemia
9%
Renal impairment
8%
Urine albumin/creatinine ratio increased
8%
Haematuria
7%
Proteinuria
6%
Hypertension
5%
Nasopharyngitis
5%
Urine protein/creatinine ratio increased
5%
Dizziness
5%
Hypotension
4%
Dyspnoea
3%
Atrial fibrillation
3%
Oedema peripheral
3%
Bronchitis
3%
Cardiac failure
3%
Diarrhoea
3%
Urinary tract infection
3%
Renal failure
2%
Arthralgia
2%
Back pain
2%
Fatigue
2%
Influenza
2%
Blood creatinine increased
2%
Headache
2%
Cough
2%
Anaemia
1%
Angina pectoris
1%
Cardiac failure acute
1%
Blood potassium increased
1%
Acute kidney injury
1%
Pneumonia
1%
Angina unstable
1%
Cardiac failure congestive
1%
Pruritus
1%
Microalbuminuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Individualized Medical Therapy (IMT)
Total
Sacubitril/Valsartan (LCZ696)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: sacubitril/valsartanExperimental Treatment1 Intervention
single arm, open label sacubitril/valsartan
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
sacubitril/valsartan
2016
Completed Phase 3
~13870

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,904 Previous Clinical Trials
4,207,799 Total Patients Enrolled
69 Trials studying Heart Failure
2,000,947 Patients Enrolled for Heart Failure

Media Library

sacubitril/valsartan (Angiotensin Receptor Neprilysin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03785405 — Phase 3
Heart Failure Clinical Trial 2023: sacubitril/valsartan Highlights & Side Effects. Trial Name: NCT03785405 — Phase 3
sacubitril/valsartan (Angiotensin Receptor Neprilysin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03785405 — Phase 3
Heart Failure Research Study Groups: sacubitril/valsartan
~33 spots leftby Nov 2025
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