Your session is about to expire
← Back to Search
Angiotensin Receptor-Neprilysin Inhibitor
Description of Tolerability of LCZ696 (Sacubitril / Valsartan) in Heart Failure With Reduced Ejection Fraction (HFrEF) Treated in Real Life Setting (PARASAIL Trial)
Phase 4
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, week 4, month 3, month 6 and month 12
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
The primary purpose of the study was to describe the tolerability of treatment with the optimal dose of LCZ696 (97 mg sacubitril / 103 mg valsartan bid), over six (6) months, in patients with heart failure with reduced ejection fraction (HFrEF) in Canada. The study was also to describe the overall tolerability, effectiveness and safety of LCZ696 for the management of HFrEF over 12 months of treatment, as well as describe the patterns of LCZ696 up and down dose titrations occurring during the management of patients with HFrEF.
Eligible Conditions
- Heart Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 2, week 4, month 3, month 6 and month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, week 4, month 3, month 6 and month 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants on LCZ696 200 mg Bid at Month 6
Secondary study objectives
Change From Baseline in the Six Minute Walk Test (6MWT) at Month 6 and Month 12
Median Time to Reach LCZ696 200 mg
Percentage of Participants Requiring Down-titration From LCZ696 200 mg
+4 moreSide effects data
From 2017 Phase 4 trial • 302 Patients • NCT0269097415%
Dizziness
10%
Hypotension
7%
Cough
6%
Diarrhoea
6%
Fatigue
4%
Cardiac failure congestive
2%
Pneumonia
1%
Acute kidney injury
1%
Dehydration
1%
Hyponatraemia
1%
Death
1%
Acute myocardial infarction
1%
Cardiac arrest
1%
Cardiac failure
1%
Ventricular tachycardia
1%
Gastroenteritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
LCZ696 (Sacubitril / Valsartan)
Awards & Highlights
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.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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: LCZ696 (sacubitril / valsartan)Experimental Treatment1 Intervention
All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valsartan
FDA approved
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,921 Previous Clinical Trials
4,254,010 Total Patients Enrolled
69 Trials studying Heart Failure
2,000,861 Patients Enrolled for Heart Failure