Study identifier:D2453C00046
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
DIRECT: DIabetic Retinopathy Candesartan Trials. Effects of candesartan cilexetil (candesartan) on diabetic retinopathy in type 1 diabetic patients with retinopathy.
Type 1 Diabetes
Phase 3
No
candesartan
All
1850
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Oct 2013 by AstraZeneca
AstraZeneca
Takeda
The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normotensive, normoalbuminuric type 1 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 of 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 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.
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: candesartan candesartan cilexetil 32 mg once daily | Drug: candesartan 32 mg oral tablet Other Name: ATACAND |
No Intervention: placebo control | - |
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