DIabetic Retinopathy Candesartan Trials.

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Takeda
• Treatments: Candesartan; Candesartan cilexetil

Criteria

Inclusion Criteria:

• Male or female aged 18 - 55 years with type 1 diabetes diagnosed before age of 36 years and in need for continuous insulin treatment within 1 year of diagnosis of diabetes are included.

• Duration of diabetes for > 1 year and < 20 years with stable diabetic therapy within last 6 months.

• Patients with untreated resting mean sitting SBP < 130 mmHg, mean sitting DBP < 85 mmHg and with retinal photograph grading level > 20/10 up to < 47/47 (on ETDRS severity scale).

Exclusion Criteria:

• Patients with the following conditions are excluded from participation on the study:

• Cataract or media opacity of a degree which precludes taking gradable retinal photographs

• Angle closure glaucoma, which precludes pharmacological dilatation of the pupil

• History or presence of proliferative retinopathy

• History or presence of clinical significant macular oedema (CSME)

• History or evidence of photocoagulation of the retina

• Other retinal conditions which may mask assessment, eg, retinal vein occlusion

• Positive micral dipstick test

• Presence of secondary diabetes

• Pregnant or lactating women or women of child bearing potential not practicing an adequate method of contraception

• Need of treatment with ACE-inhibitor

• Haemodynamically significant aortic or mitral valve stenosis

• Known renal artery stenosis or kidney transplantation

• Hypersensitivity to study drug

• Severe concomitant disease which may interfere with the assessment of the patient, eg, malignancy, as judged by the investigator