Status:
COMPLETED
DIabetic Retinopathy Candesartan Trials
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Takeda
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
37-75 years
Phase:
PHASE3
Brief Summary
The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normoalbuminuric type 2 diabetic patients with retinopathy. The secon...
Eligibility Criteria
Inclusion
- Male or female aged 37 - 75 years with type 2 diabetes diagnosed at age of 36 years or thereafter.
- 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 and mean sitting DBP \< 85 or treated resting mean SBP \< 160 mmHg and mean sitting DBP \< 90 mmHg with retinal photograph grading level \>20/10 up to \< 47/47 (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 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
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
4717 Patients enrolled
Trial Details
Trial ID
NCT00252694
Start Date
August 1 2001
End Date
April 1 2008
Last Update
June 6 2014
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