SAFETY AND TOLERABILITY DURING OPEN-LABEL TREATMENT WITH LCZ696 IN PATIENTS WITH CHRONIC HEART FAILURE AND REDUCED EJECTION FRACTION

A MULTICENTER STUDY TO EVALUATE SAFETY AND TOLERABILITY IN PATIENTS WITH CHRONIC HEART FAILURE AND REDUCED EJECTION FRACTION FROM PARADIGM-HF RECEIVING OPEN LABEL LCZ696

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-034-15

Enrollment

116

Registered

2015-12-30

Start date

2015-10-19

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

This trial is a multicenter, open-label follow-up to PARADIGMHF, which evaluated the morbidity, mortality and safety of LCZ696 compared to enalapril in patients with chronic heart failure and reduced

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Written informed consent for the extension must be obtained before any assessment is performed. 2. Patients who have completed PARADIGM-HF and are able to safely transition into the open-label study as judged by the investigator.

Exclusion criteria

Exclusion criteria: 1. Any condition that in the opinion of the investigator is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the study.

Countries

Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Guatemala, Hungary, India, Israel, Italy, Japan, Korea North, Korea South, Latvia, Malasya, Mexico, Panama, Peru, Portugal, Russian Federation, Singapore, Sweden, Switzerland, Thailand, United Kindgdom, United States, Venezuela

Contacts

Public ContactKarim Luque

NOVARTIS BIOSCIENCES PERU S.A.

karim.luque@novartis.com2006400

Outcome results