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
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.
Clinical Details
Official title: DIRECT: DIabetic Retinopathy Candesartan Trials. Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients With Retinopathy.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Progression of diabetic retinopathy is a change from baseline to any retinal photograph taken after the randomization visit by at least 3 steps 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: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
severity scale).
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 retinal
photographs
- 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
Additional Information
Starting date: August 2001
Ending date: June 2008
Last updated: February 2, 2008
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