DIabetic Retinopathy Candesartan Trials.
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes
Intervention: candesartan (Drug)
Phase: Phase 3
Sponsored by: AstraZeneca
Official(s) and/or principal investigator(s):
AstraZeneca Atacand Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
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
Official title: DIRECT: DIabetic Retinopathy Candesartan Trials. Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients With Retinopathy.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale
Number of Participants With a Regression of Diabetic Retinopathy.
Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).
Rate of Change in Urinary Albumin Excretion Rate (UAER).
Minimum age: 18 Years.
Maximum age: 55 Years.
- 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
- Patients with the following conditions are excluded from participation on the study:
- Cataract or media opacity of a degree which precludes taking gradable retinal
- 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
Locations and Contacts
Starting date: August 2001
Last updated: May 9, 2014