CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,717 enrolled
Drug / intervention
candesartandrug
Likely dose
candesartan 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/NCT00252694
NCT00252694Phase 3Completed

Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 2 Diabetic Patients With Retinopathy.

AstraZeneca·interventional·Posted Nov 15, 2005·Updated Jun 6, 2014

In Brief

A Phase 3 clinical trial evaluating candesartan for Type 2 Diabetes. Completed, enrolled 4,717 participants.

Detailed Summary

The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normoalbuminuric type 2 diabetic patients with retinopathy. The secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic retinopathy (PDR) and beneficially influences the rate change in urinary albumin excretion rate (UAER). This study is part of the DIRECT Programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 1 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 2 Diabetes
Countries--
CollaboratorsTakeda

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 15, 2005
Enrollment StartAug 1, 2001
Primary CompletionFeb 1, 2008
Study CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 20.6 years ago

Interventions

candesartandrug

32 mg oral tablet