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

Last updated: November 16, 2021
Sponsor: Novartis Pharmaceuticals
Overall Status: Trial Not Available

Phase

3

Condition

Heart Defect

Congestive Heart Failure

Angina

Treatment

N/A

Clinical Study ID

NCT04637555
CLCZ696G2301E1
2020-003906-29
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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) inPARADISE-MI.
  3. Participant is safe to be enrolled in the extension study and may benefit from thetreatment of LCZ696 per investigator's clinical judgement.

Exclusion

Exclusion Criteria:

  1. Participant with a known history of angioedema
  2. History of hypersensitivity to the study drug or drugs of similar chemical classes orknown intolerance or contraindications to study drug or drugs of similar chemicalclasses 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 increasedammonia levels, if performed), or history of cirrhosis with evidence of portalhypertension such as esophageal varices
  6. Pregnant or nursing women or women of child-bearing potential unless they are usinghighly effective methods of contraception
  7. Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Study Start date:
May 26, 2021
Estimated Completion Date:
June 01, 2023