DIabetic Retinopathy Candesartan Trials. - Full Text View

Sponsors and Collaborators:	AstraZeneca Takeda Global Research & Development Center, Inc.
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00252720

Purpose

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.

Condition	Intervention	Phase
Type 1 Diabetes	Drug: Candesartan Cilexetil	Phase III

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

Drug Information available for: Candesartan cilexetil CV 11974

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	DIRECT: DIabetic Retinopathy Candesartan Trials. Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients With Retinopathy.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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. [ Time Frame: Assessed at the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Enrollment:	1850
Study Start Date:	August 2001
Estimated Study Completion Date:	June 2008
Estimated 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 oral tablet

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252720

Sponsors and Collaborators

AstraZeneca

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

AstraZeneca Atacand Medical Science Director, MD

AstraZeneca

More Information

Publications indexed to this study:

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:	D2453C00046, DIRECT, SH-AHM-0046
Study First Received:	November 10, 2005
Last Updated:	February 2, 2008
ClinicalTrials.gov Identifier:	NCT00252720
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by AstraZeneca:

Diabetes mellitus type 1

Study placed in the following topic categories:

Metabolic Diseases
Autoimmune Diseases
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Angiotensin II
Diabetic Angiopathies
Candesartan cilexetil

Diabetic Retinopathy
Diabetes Mellitus, Type 1
Candesartan
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Retinal Diseases
Diabetes Complications

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Therapeutic Uses

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009