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

NCT04637555 | Withdrawn Phase 3 FDA Drug

• 2 other identifiers: CLCZ696G2301E12020-003906-29
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post Myocardial Infarction

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

  Up to 24 months

• Number of participants with Serious Adverse Events (SAEs)

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

  Up to 24 months

• 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

  Baseline and up to 24 months

Study Arms (1)

LCZ696 (sacubitril/valsartan)

EXPERIMENTAL

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

Drug: sacubitril/valsartan

Interventions

sacubitril/valsartan DRUG

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

Also known as: LCZ696

LCZ696 (sacubitril/valsartan)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Interventions

sacubitril and valsartan sodium hydrate drug combination

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 19, 2020
• Study Start: May 26, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: November 26, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share