Diabetic Retinopathy Candesartan Trials
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes
Intervention: candesartan cilexetil (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Atacand Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
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 retinopathy.
The secondary objective is to determine whether candesartan, compared to placebo,
beneficially influences the rate of change in urinary albumin excretion rate (UAER).
This study is part of the DIRECT Programme also including secondary prevention studies of
diabetic retinopathy in both type 1 and 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.
Clinical Details
Official title: Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients Without Retinopathy.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Incidence of diabetic retinopathy is a change from baseline to any retinal photograph taken after the randomization visit by at least 2 steps from 10/10 in the ETDRS severity scale.
Secondary outcome: The rate of change in mean urinary albumin excretion rate (UAER)
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Research Site, Perth, Australia
Research Site, Herston, Australia
Research Site, Odense, Denmark
Additional Information
Starting date: August 2001
Ending date: June 2008
Last updated: February 2, 2008
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