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

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: LCZ 696; Valsartan

Criteria

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