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

NCT06099067 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 239990

Last updated 2024-08-30

No results posted yet for this study

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

Conditions

Interventions

DRUG

Canagliflozin

Canagliflozin dispensing claim is used as the exposure drug in CANVAS replication

DRUG

DPP4 inhibitor

DPP4 inhibitor dispensing claim is used as the reference drug in CANVAS and LEADER replications

DRUG

Liraglutide

Liraglutide dispensing claim is used as the Exposure drug in LEADER replication

DRUG

Saxagliptin

Saxagliptin dispensing claim is used as the Exposure drug in SAVOR-TIMI replication

DRUG

2nd generation Sulfonylurea

2nd generation Sulfonylurea dispensing claim is used as the Exposure drug in SAVOR-TIMI replication

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-15
Primary Completion
2023-08-31
Completion
2023-08-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06099067 on ClinicalTrials.gov