DIabetic Retinopathy Candesartan Trials (DIRECT)
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 2 Diabetic Patients With Retinopathy.|
- Progression of diabetic retinopathy is a change from baseline to any retinal photograph taken after the randomization visit by at least 3 steps in the ETDRS severity scale. [ Time Frame: Assessed at the end of the study ] [ Designated as safety issue: No ]
- The rate of change in mean urinary albumin excretion rate (UAER) [ Time Frame: Assessed from baseline to the end of the study. ] [ Designated as safety issue: No ]
|Study Start Date:||August 2001|
|Study Completion Date:||April 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
No Intervention: 1
Drug: Candesartan cilexetil
32 mg oral tablet
Other Name: ATACAND