DIabetic Retinopathy Candesartan Trials. - Tabular View

Tracking Information

First Received Date ^ICMJE

November 10, 2005

Last Updated Date

March 9, 2009

Start Date ^ICMJE

August 2001

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00252720 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

The rate of change in mean urinary albumin excretion rate (UAER) from baseline to the end of the study.

Descriptive Information

Brief Title ^ICMJE

DIabetic Retinopathy Candesartan Trials.

Official Title ^ICMJE

DIRECT: DIabetic Retinopathy Candesartan Trials. Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients With Retinopathy.

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Type 1 Diabetes

Intervention ^ICMJE

Drug: Candesartan Cilexetil

Study Arms / Comparison Groups

No Intervention: Placebo
Experimental: Candesartan cilexetil

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1850

Completion Date

April 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00252720

Responsible Party

Study ID Numbers ^ICMJE

D2453C00046, DIRECT, SH-AHM-0046

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Takeda Global Research & Development Center, Inc.

Investigators ^ICMJE

Study Director:

AstraZeneca Atacand Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP