completed

The objective of the ORIGINALE study was to continue to follow patients in an observational study to the ORIGIN trial.

Primary endpoint:

The composite of CV death, non-fatal MI, non-fatal stroke, and significant heart failure.

Secondary endpoints:

  • Decline in the ability to perform everyday activities (key secondary outcome)
  • Renal dysfunction (primary outcome: end stage renal disease [ESRD] requiring dialysis or transplantation or doubling of serum creatinine
  • Total mortality

All primary and secondary endpoints are adjudicated.

Study Type

Interventional - Drug

Study Design

Observational extension

NO. of Countries

40

NO. of Sites

578

NO. of Participants

4718

Study Period

2013

Sponsor

Sanofi

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