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Angiotensin Receptor Neprilysin Inhibitor

sacubitril/valsartan for Heart Failure

Q: What is the primary medical condition that sacubitril/valsartan is indicated for?

<p>sacubitril/v<a href="https://www.withpower.com/clinical-trials/als">als</a>artan is most often given to patients with left ventricular dysfunction. It can also be used to lower blood pressure in patients that haven't respond well to other treatments and to prevent <a href="https://www.withpower.com/clinical-trials/cardiovascular">cardiovascular</a> events.</p>

Novartis Investigative Site, Konak-Izmir, Turkey

sacubitril/valsartanPhase 3Waitlist AvailableResearch 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

Must not have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upto end of study, up to 3 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Study Summary

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to end of study, up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to end of study, up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and to end of study, up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with Adverse Events (AEs) as a measure of safety and tolerability

Number of participants with Serious Adverse Events (SAEs) as a measure of safety and tolerability

Side effects data

From 2019 Phase 3 trial • 2572 Patients • NCT03066804

12%

Glomerular filtration rate decreased

11%

Hyperkalaemia

Renal impairment

Urine albumin/creatinine ratio increased

Haematuria

Proteinuria

Hypertension

Nasopharyngitis

Urine protein/creatinine ratio increased

Dizziness

Hypotension

Dyspnoea

Oedema peripheral

Bronchitis

Atrial fibrillation

Cardiac failure

Diarrhoea

Urinary tract infection

Renal failure

Fatigue

Influenza

Blood creatinine increased

Arthralgia

Back pain

Headache

Cough

Anaemia

Blood potassium increased

Cardiac failure acute

Acute kidney injury

Pneumonia

Angina unstable

Cardiac failure congestive

Pruritus

Microalbuminuria

Angina pectoris

100%

80%

60%

40%

20%

Study treatment Arm

Individualized Medical Therapy (IMT)

Total

Sacubitril/Valsartan (LCZ696)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

FDA approved

Do I qualify?Apply below to find out

Find a site

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,810 Previous Clinical Trials

4,030,766 Total Patients Enrolled

66 Trials studying Heart Failure

2,000,754 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are middle-aged individuals being accepted into this research project?

"Children aged 1 year to 18 years old are eligible for this clinical trial. In total, there are 25 clinical trials for patients under 18 and 758 for people 65 and older."

Answered by AI

Could I qualify to join this experiment?

"This study, which is looking for 217 individuals with a history of heart failure, has the following requirements for applicants: They must have given informed consent, be taking the study drug at the EOS visit for PANORAMA-HF Part 2, and not have any major safety concerns."

Answered by AI

What is the primary medical condition that sacubitril/valsartan is indicated for?

"sacubitril/valsartan is most often given to patients with left ventricular dysfunction. It can also be used to lower blood pressure in patients that haven't respond well to other treatments and to prevent cardiovascular events."

Answered by AI

Is this the first time that sacubitril/valsartan is being trialed?

"There are currently 39 different ongoing clinical trials for sacubitril/valsartan. Phase 3 trials, which are the most advanced, are being conducted at 8 of those locations. Most of the research is taking place in Montreal, Quebec, but there are 812 sites total."

Answered by AI

What are some known risks associated with sacubitril/valsartan?

"Although it is still in Phase 3, sacubitril/valsartan has shown efficacy in some patients and has been proven to be safe multiple times. Therefore, it received a score of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CLCZ696B2319E1 OL Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF

2019. "CLCZ696B2319E1 OL Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03785405.