Open-label extension study for CLCZ696G2301 (PARADISE-MI)

Phase 1

• Conditions: eft ventricular dysfunction following an acute myocardial infarction and/or pulmonary congestion requiring intravenous treatment; MedDRA version: 20.0Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-003906-29-SE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-29
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2000

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 850

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified