Status:
COMPLETED
Diabetic Retinopathy Candesartan Trials
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Takeda
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief Summary
The primary objective is to determine whether candesartan, compared to placebo reduces the incidence of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients without retinopa...
Eligibility Criteria
Inclusion
- 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 \< 15 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 10/10 (on ETDRS severity scale).
Exclusion
- Patients with the following conditions are excluded from participation in 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 of 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
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
5238 Patients enrolled
Trial Details
Trial ID
NCT00252733
Start Date
June 1 2001
End Date
April 1 2008
Last Update
May 14 2014
Active Locations (3)
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1
Research Site
Herston, Australia
2
Research Site
Perth, Australia
3
Research Site
Odense, Denmark