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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2023

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 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)

Clinical Trial Outcome Measures

Primary 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
    • Time Frame: Up to 24 months
    • Adverse events (AEs) leading to treatment changes including treatment discontinuation, interruption, and dose adjustment
  • Number of participants with Serious Adverse Events (SAEs)
    • Time Frame: Up to 24 months
    • SAE(s) will be reported, and the number of participants with SAE(s) will be summarized
  • Vital signs (Blood Pressure and pulse)
    • Time Frame: Baseline and up to 24 months
    • 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

Participating in This Clinical Trial

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 7. Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
  • Overall Contact(s)
    • Novartis Pharmaceuticals, 1-888-669-6682, novartis.email@novartis.com

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