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Open-label Extension Study for CLCZ696G2301 (PARADISE-MI)

NCT ID: NCT04637555

Last Updated: 2021-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-26

Study Completion Date

2023-06-01

Brief Summary

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The purpose of this study is to collect long-term safety and tolerability data of LCZ696 and to provide open-label LCZ696 to eligible participants who completed CLCZ696G2301 study (PARADISE-MI) if LCZ696 is shown to have a positive benefit-risk profile in comparison to ramipril in reducing risk of cardiovascular (CV) mortality and development of heart failure in participants enrolled in the PARADISE-MI study.

Detailed Description

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Conditions

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Post Myocardial Infarction

Keywords

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LCZ696 Open-Label Extension PARADISE-MI Post Myocardial Infarction Post Heart Attack CLCZ696G2301

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a multicenter, open-label extension study following-up to PARADISE-MI, which evaluated the efficacy and safety of LCZ696 compared to ramipril, in reducing the occurrence of CV death, heart failure (HF) hospitalization and outpatient HF (time-to-first event analysis) in post-acute myocardial infarction (AMI) patients with evidence of left ventricular (LV) systolic dysfunction and/or pulmonary congestion, without a known prior history of chronic HF. The study duration is up to approximately 24 months with visits at Days -14 to 1, 1, 15, 29 and Months 3, 6, 12, 18, and 24. Participants will receive LCZ696 at maximally tolerated doses with a target dose of 200 mg twice daily at all visits between day 1 and the last visit.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open label

Study Groups

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LCZ696 (sacubitril/valsartan)

Following start of treatment, patients will receive LCZ696. Possible doses are level 1, 2, and 3 (50, 100 and 200 mg twice daily respectively)

Group Type EXPERIMENTAL

sacubitril/valsartan

Intervention Type DRUG

LCZ696 (sacubitril/valsartan) tablet will be available in 24/26 mg, 49/51 mg and 97/103 mg, respectively

Interventions

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sacubitril/valsartan

LCZ696 (sacubitril/valsartan) tablet will be available in 24/26 mg, 49/51 mg and 97/103 mg, respectively

Intervention Type DRUG

Other Intervention Names

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LCZ696

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed.
2. Participant received study treatment (either in LCZ696 or ramipril treatment arm) in PARADISE-MI.
3. Participant is safe to be enrolled in the extension study and may benefit from the treatment of LCZ696 per investigator's clinical judgement.

Exclusion Criteria

1. Participant with a known history of angioedema
2. History of hypersensitivity to the study drug or drugs of similar chemical classes or known intolerance or contraindications to study drug or drugs of similar chemical classes including ACE inhibitors, ARB or NEP inhibitors
3. Symptomatic hypotension at screening
4. Serum potassium \> 5.2 mmol /L (or equivalent plasma potassium value) at screening
5. Known hepatic impairment (as evidenced by total bilirubin \> 3.0 mg/dL or increased ammonia levels, if performed), or history of cirrhosis with evidence of portal hypertension such as esophageal varices
6. Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

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2020-003906-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLCZ696G2301E1

Identifier Type: -

Identifier Source: org_study_id