Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252694
Status:
COMPLETED
Last Update Posted:
2014-06-06
First Post:
2005-11-10
Brief Title:
DIabetic Retinopathy Candesartan Trials
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Effects of Candesartan Cilexetil Candesartan on Diabetic Retinopathy in Type 2 Diabetic Patients With Retinopathy
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIRECT
Brief Summary:
The primary objective is to determine whether candesartan compared to placebo reduces the progression of diabetic retinopathy in normoalbuminuric type 2 diabetic patients with retinopathy
The secondary objective is to determine whether candesartan compared to placebo reduces the incidence of clinically significant macular oedema CSME andor proliferative diabetic retinopathy PDR and beneficially influences the rate 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 1 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
The secondary objective is to determine whether candesartan compared to placebo reduces the incidence of clinically significant macular oedema CSME andor proliferative diabetic retinopathy PDR and beneficially influences the rate 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 1 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SH-AHM-0047 | None | None | None |
| DIRECT | None | None | None |