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Angiotensin Receptor-Neprilysin Inhibitor

LCZ696 (sacubitril / valsartan) for Heart Failure (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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2, week 4, month 3, month 6 and month 12 for reporting.

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 more

Side effects data

From 2017 Phase 4 trial • 302 Patients • NCT02690974

15%

Dizziness

10%

Hypotension

Cough

Diarrhoea

Fatigue

Cardiac failure congestive

Pneumonia

Acute kidney injury

Dehydration

Hyponatraemia

Death

Acute myocardial infarction

Cardiac arrest

Cardiac failure

Ventricular tachycardia

Gastroenteritis

100%

80%

60%

40%

20%

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

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