Status:

COMPLETED

Harmonizing RCT-Duplicate Emulations In A Real World Replication Program (HARRP)

Lead Sponsor:

AstraZeneca

Conditions:

Type 2 Diabetes Mellitus

Eligibility:

All Genders

Brief Summary

Replication of three clinical trial emulations CANVAS, LEADER, and SAVOR TIMI that form part of the RCT-Duplicate initiative, sponsored by the FDA and delivered by the Brigham and Women's Hospital and...

Detailed Description

RCT-duplicate (RCT-D) is an initiative led by the Brigham and Women's Hospital and Harvard Medical School, that selected 30 clinical trials as part of an empirical experiment where these trials would ...

Eligibility Criteria

Inclusion

  • The Eligibility Criteria for CANVAS, LEADER and SAVOR-TIMI are replicated
  • Please see the Criteria for each under:
  • CANVAS: https://clinicaltrials.gov/ct2/show/NCT03936010
  • LEADER: https://clinicaltrials.gov/ct2/show/NCT03936049
  • SAVOR-TIMI: https://clinicaltrials.gov/ct2/show/NCT03936023

Exclusion

    Key Trial Info

    Start Date :

    May 15 2020

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    August 31 2023

    Estimated Enrollment :

    239990 Patients enrolled

    Trial Details

    Trial ID

    NCT06099067

    Start Date

    May 15 2020

    End Date

    August 31 2023

    Last Update

    August 30 2024

    Active Locations (1)

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    1

    Research Site

    Gothenburg, Sweden, 43183

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