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Nortriptyline and the Risk of Serious Adverse Events

NCT07527481 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2026-06-09

No results posted yet for this study

Summary

This is a population-based retrospective, new-user, active comparator cohort study assessing whether initiating a new outpatient prescription of high-dose nortriptyline (\>10-150 mg/day), compared with low-dose (10 mg/day), is associated with an increased 30-day risk of serious adverse events among older adults with low kidney function (estimated glomerular filtration rate \[eGFR\] \<45 ml/min/1.73m2) who are not receiving dialysis and have no history of kidney transplantation.

The primary outcome is a 30-day composite of all-cause emergency department visit, all-cause hospitalization, or all-cause mortality.

Conditions

Interventions

DRUG

Nortriptyline Hydrochloride

The primary exposure of interest will be oral nortriptyline at a dose of \>10-150 mg/day. For the primary comparison, oral nortriptyline at 10 mg/day will serve as the referent group to reduce confounding by indication.

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Eligibility

Min Age
66 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-01
Primary Completion
2025-12-01
Completion
2025-12-31

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Entities

Diseases

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 NCT07527481 on ClinicalTrials.gov