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

Primary Purpose

Post Myocardial Infarction

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

sacubitril/valsartan

About this trial

This is an interventional treatment trial for Post Myocardial Infarction focused on measuring LCZ696, Open-Label Extension, PARADISE-MI, Post Myocardial Infarction, Post Heart Attack, CLCZ696G2301

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed.
Participant received study treatment (either in LCZ696 or ramipril treatment arm) in PARADISE-MI.
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:

Participant with a known history of angioedema
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
Symptomatic hypotension at screening
Serum potassium > 5.2 mmol /L (or equivalent plasma potassium value) at screening
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
Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception
Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LCZ696 (sacubitril/valsartan)

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants with AE(s) leading to permanent study drug discontinuation, temporary study drug interruption, or study drug dose adjustment will be reported and summarized

Adverse events (AEs) leading to treatment changes including treatment discontinuation, interruption, and dose adjustment

Number of participants with Serious Adverse Events (SAEs)

SAE(s) will be reported, and the number of participants with SAE(s) will be summarized

Vital signs (Blood Pressure and pulse)

BP and pulse will be measured at every visit. The test values of Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg) and heart rate (rate/minute) as well as change from the baseline will be summarized by parameter, using number of observations, mean, standard deviation, median, minimum, and maximum

Secondary Outcome Measures

Full Information

NCT ID

NCT04637555

First Posted

November 4, 2020

Last Updated

November 16, 2021

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04637555

Brief Title

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

Official Title

A Multicenter Study to Evaluate the Long-term Safety and Tolerability of Open-label LCZ696 in Patients With Acute Myocardial Infarction Who Previously Participated in CLCZ696G2301 (PARADISE-MI)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Withdrawn

Why Stopped

CLCZ696G2301E1 extension study did not start as the core study (CLCZ696G2301) did not meet the primary endpoint.

Study Start Date

May 26, 2021 (Anticipated)

Primary Completion Date

June 1, 2023 (Anticipated)

Study Completion Date

June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Myocardial Infarction

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Masking Description

Open label

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LCZ696 (sacubitril/valsartan)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

sacubitril/valsartan

Other Intervention Name(s)

LCZ696

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with AE(s) leading to permanent study drug discontinuation, temporary study drug interruption, or study drug dose adjustment will be reported and summarized

Description

Adverse events (AEs) leading to treatment changes including treatment discontinuation, interruption, and dose adjustment

Time Frame

Up to 24 months

Title

Number of participants with Serious Adverse Events (SAEs)

Description

SAE(s) will be reported, and the number of participants with SAE(s) will be summarized

Time Frame

Up to 24 months

Title

Vital signs (Blood Pressure and pulse)

Description

Time Frame

Baseline and up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent must be obtained before any assessment is performed. Participant received study treatment (either in LCZ696 or ramipril treatment arm) in PARADISE-MI. 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: Participant with a known history of angioedema 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 Symptomatic hypotension at screening Serum potassium > 5.2 mmol /L (or equivalent plasma potassium value) at screening 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 Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception Other protocol-defined inclusion/exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

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

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