CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,238 enrolled
Drug / intervention
candesartan cilexetildrug
Likely dose
candesartan cilexetil 32 mgfrom 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/NCT00252733
NCT00252733Phase 3Completed

Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients Without Retinopathy.

AstraZeneca·interventional·Posted Nov 15, 2005·Updated May 14, 2014

In Brief

A Phase 3 clinical trial evaluating candesartan cilexetil for Type 1 Diabetes. Completed, enrolled 5,238 participants across 3 sites in 2 countries.

Detailed Summary

The primary objective is to determine whether candesartan, compared to placebo reduces the incidence of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients without retinopathy. The secondary objective is to determine whether candesartan, compared to placebo, beneficially influences the rate of change in urinary albumin excretion rate (UAER). This study is part of the DIRECT Programme also including secondary prevention studies of diabetic retinopathy in both type 1 and type 2 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesAustralia, Denmark
CollaboratorsTakeda

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 15, 2005
Enrollment StartJun 1, 2001
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 20.6 years ago

Interventions

candesartan cilexetildrug

32 mg once daily oral tablet given over 60 months