DIabetic Retinopathy Candesartan Trials.

Last updated: May 9, 2014
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

Diabetes And Hypertension

Diabetic Retinopathy

Diabetes Mellitus, Type 1

Treatment

N/A

Clinical Study ID

NCT00252720
D2453C00046
DIRECT
SH-AHM-0046
  • Ages 18-55
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

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

Exclusion

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 retinalphotographs

  • 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 anadequate 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

Study Design

Total Participants: 1850
Study Start date:
August 01, 2001
Estimated Completion Date:
April 30, 2008