Diabetic Retinopathy Candesartan Trials

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

5238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2008-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

DIabetic Retinopathy Candesartan Trials.

NCT00252720

Type 1 Diabetes

COMPLETED PHASE3

DIabetic Retinopathy Candesartan Trials

NCT00252694

Type 2 Diabetes

COMPLETED PHASE3

Phase III Study of Compound Danshen Dripping Pills to Treat Diabetic Retinopathy

NCT02388984

Non-proliferative Diabetic Retinopathy

UNKNOWN PHASE3

Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy

NCT02816710

Proliferative Diabetic Retinopathy Tractional Retinal Detachment

COMPLETED PHASE4

The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.

NCT01320345

Type 1 Diabetes Mellitus Diabetic Retinopathy Diabetic Nephropathies

ACTIVE_NOT_RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

2

candesartan cilexetil

Group Type EXPERIMENTAL

candesartan cilexetil

Intervention Type DRUG

32 mg once daily oral tablet given over 60 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

candesartan cilexetil

32 mg once daily oral tablet given over 60 months

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ATACAND

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No