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

Post Myocardial Infarction Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04637555
• Other study ID #: CLCZ696G2301E1
• Secondary ID: 2020-003906-29
• Status: Withdrawn
• Phase: Phase 3
• Start date: May 26, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: November 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Post Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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