Diabetic Retinopathy Candesartan Trials - Full Text View

Sponsor:	AstraZeneca
Collaborator:	Takeda Global Research & Development Center, Inc.
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00252733

Purpose

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.

Condition	Intervention	Phase
Type 1 Diabetes	Drug: candesartan cilexetil	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients Without Retinopathy.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1 Diabetic Eye Problems Retinal Disorders

Drug Information available for: CV 11974 Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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. [ Time Frame: assessed after 60 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The rate of change in mean urinary albumin excretion rate (UAER) [ Time Frame: from baseline to the end of the study (60 months) ] [ Designated as safety issue: No ]

Enrollment:	5238
Study Start Date:	August 2001
Study Completion Date:	April 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Placebo
2: Experimental candesartan cilexetil	Drug: candesartan cilexetil 32 mg once daily oral tablet given over 60 months

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252733

Locations

Australia
Research Site
Perth, Australia
Research Site
Herston, Australia
Denmark
Research Site
Odense, Denmark

Sponsors and Collaborators

AstraZeneca

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

AstraZeneca Atacand Medical Science Director, MD

AstraZeneca

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Bilous R, Chaturvedi N, Sjølie AK, Fuller J, Klein R, Orchard T, Porta M, Parving HH. Effect of candesartan on microalbuminuria and albumin excretion rate in diabetes: three randomized trials. Ann Intern Med. 2009 Jul 7;151(1):11-20, W3-4. Epub 2009 May 18.

Chaturvedi N, Porta M, Klein R, Orchard T, Fuller J, Parving HH, Bilous R, Sjølie AK; DIRECT Programme Study Group. Effect of candesartan on prevention (DIRECT-Prevent 1) and progression (DIRECT-Protect 1) of retinopathy in type 1 diabetes: randomised, placebo-controlled trials. Lancet. 2008 Oct 18;372(9647):1394-402. Epub 2008 Sep 25.

Study ID Numbers:	D2453C00045, DIRECT, SH-AHM-0045
Study First Received:	November 10, 2005
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00252733 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by AstraZeneca:

Diabetes Mellitus, Insulin-Dependent

Additional relevant MeSH terms:

Metabolic Diseases
Autoimmune Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Diabetic Angiopathies
Angiotensin II Type 1 Receptor Blockers
Candesartan cilexetil
Diabetic Retinopathy
Diabetes Mellitus, Type 1
Therapeutic Uses
Candesartan
Cardiovascular Diseases
Glucose Metabolism Disorders
Diabetes Complications
Retinal Diseases

ClinicalTrials.gov processed this record on February 08, 2010