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Rapid Versus Prolonged Inpatient Up-Titration of Captopril

Information source: The Hospital for Sick Children
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Disease

Intervention: Captopril (Drug); Captopril (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: The Hospital for Sick Children

Official(s) and/or principal investigator(s):
Paul Kantor, MD, Principal Investigator, Affiliation: The Hospital for Sick Children


The primary objective of this study is to establish a safe and effective method of up-titration of captopril for hospital inpatients.

Clinical Details

Official title: Rapid Versus Prolonged Inpatient Up-Titration of Captopril: A Randomized Clinical Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The number of patients reaching a target dose of 1mg/kg/dose (given three times a day).

Detailed description: Angiotensin converting enzyme inhibitors (ACEi) are one of the most frequently prescribed pediatric cardiac medication and overall their safety in children is widely accepted. Pediatric formulary recommendations for ACEi suggest starting with a low initial dose (0. 1 mg/kg), to avoid hypotension, and up-titration for a maintenance dose. However, side ranges are quoted for maintenance doses and no guidance is given as to the best method of up-titration, The physician is left uncertain of the optimal dose and how best to achieve it. The ultimate goal of this study is to be in a position to provide physicians caring for children with heart disease information about how to safely up-titrate this widely used medication, and by doing so to improve dosing in the wider pediatric population.


Minimum age: N/A. Maximum age: 18 Years. Gender(s): Both.


Inclusion Criteria:

- Pediatric cardiology in-patients at The Hospital for Sick Children

- Primary physician has decided to commence ACEi (the division has agreed that our

institutional choice will be to start patients on captopril and up-titrate to optimal dose before converting to other ACEi)

- Patients who have been initiated on captopril within the prior 24 hours, but have not

yet started up-titration, will be eligible to be randomized Exclusion Criteria:

- Known sensitivity to ACEi

- Infants on the neonatal intensive care unit

- Treatment with any ACEi for more than 24 hours within the preceding 6 months

- Age > 18 years

Locations and Contacts

The Hospital for Sick Children, Toronto, Ontario, Canada; Recruiting
Paul Kantor, MD, Phone: (416)813-7239, Email: paul.kantor@sickkids.ca
Paul Kantor, MD, Principal Investigator
Lucy Roche, MD, Sub-Investigator
Katherine Timberlake, MD, Sub-Investigator
Brian McCrindle, MD, Sub-Investigator
Mervin Balasingam, Sub-Investigator
Additional Information

Starting date: August 2008
Last updated: August 26, 2008

Page last updated: August 20, 2015

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