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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

Status: Completed

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: 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

Secondary outcome:

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).

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

CSR-D2453C00046.pdf

Starting date: August 2001
Last updated: May 9, 2014

Page last updated: August 20, 2015

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