CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 443 enrolled
Drug / intervention
Statin +3 moredrug
Likely dose
Statin 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01581476
NCT01581476Phase 3Completed
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Randomised, Double Blind, Placebo Controlled Trial of Angiotensin Converting Enzyme Inhibitors and Statins in the Prevention of Long Term Complications in Young People With Type 1 Diabetes

University of Cambridge·interventional·Posted Apr 20, 2012·Updated Jun 28, 2018

In Brief

A Phase 3 clinical trial evaluating Statin, ACE inhibitor, and 2 other interventions for Type 1 Diabetes. Completed, enrolled 443 participants across 2 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine whether use of blood pressure lowering drugs, Angiotensin converting enzyme inhibitors (ACEIs) and blood fat (lipid) lowering drugs (statins) may have a place in the treatment of adolescents with diabetes and can help reduce serious long-term health problems in this population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesAustralia, Canada
CollaboratorsJuvenile Diabetes Research Foundation, Diabetes UK, British Heart Foundation, Pfizer, The University of Western Australia, The Hospital for Sick Children, University of Oxford, St Thomas' Hospital, London

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2012
Enrollment StartJan 1, 2009
Primary CompletionApr 1, 2017
Study CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 14.2 years ago

Interventions

Statindrug

10mg daily for a minimum period of 2 years

ACE inhibitordrug

Starting dose of 5mg daily rising after 14 days to 10mg daily providing it is well tolerated for a minimum period of 2 years.

Placebodrug

Participants receive statin placebo and ACEI placebo

Combination therapydrug

Participants receive both active statin and active ACEI. Dose for Statins is 10mg daily. Dosing for ACEI starts at 5mg daily rising to 10mg after 14 days providing it is well tolerated. Both interventions last for a minimum of 2 years.