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

Sponsor
AstraZeneca
Study ID
NCT06099067
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin — DRUG
    Canagliflozin dispensing claim is used as the exposure drug in CANVAS replication
  • DPP4 inhibitor — DRUG
    DPP4 inhibitor dispensing claim is used as the reference drug in CANVAS and LEADER replications
  • Liraglutide — DRUG
    Liraglutide dispensing claim is used as the Exposure drug in LEADER replication
  • Saxagliptin — DRUG
    Saxagliptin dispensing claim is used as the Exposure drug in SAVOR-TIMI replication
  • 2nd generation Sulfonylurea — DRUG
    2nd generation Sulfonylurea dispensing claim is used as the Exposure drug in SAVOR-TIMI replication

Study Details

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 Harvard Medical School. AstraZeneca will use the Instant Health Data platform PANALGOS (IHD) for the analyses.

Key Dates

Start date
May 15, 2020
Status verified
Aug 2024
Primary completion
Aug 31, 2023
Completion
Aug 31, 2023

Study Design

Enrollment
239,990 participants (actual)

Arms

  • Arm: CANVAS Canagliflozin
    CANVAS expousre Group
  • Arm: CANVAS DPP4i
    CANVAS reference Group
  • Arm: LEADER Liraglutide
    LEADER exposure Group
  • Arm: LEADER DPP4i
    LEADER reference Group
  • Arm: SAVOR-TIMI Saxagliptin
    SAVOR-TIMI exposure Group
  • Arm: SAVOR-TIMI 2nd generation Sulfonylurea
    SAVOR-TIMI reference Group

Primary Outcome Measure

3-point MACE [ Time Frame: Follow up begins the day after drug initiation for the three investigated studies [a median of 134-167 days] ]

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