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DIabetic Retinopathy Candesartan Trials. (DIRECT)

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: November 10, 2005
Last updated: May 9, 2014
Last verified: April 2014
Results First Received: March 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 1 Diabetes
Intervention: Drug: candesartan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First subject enrolled in the DIRECT programme 8 June 2001 and last subject completed the DIRECT programme 16 April 2008 mainly in hospital based clinics. The study investigators enrolled 4514 patients with type 1 diabetes to either Study 45 or 46, of whom 1905 proceeded to randomization into Study 46 (1421 into Study 45).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The most common reason for not being randomized was that all eligibility criteria were not fulfilled, followed by withdrawn informed consent.

Reporting Groups
Candesartan Candesartan cilexetil 32 mg once daily
Placebo Placebo Comparator

Participant Flow:   Overall Study
    Candesartan   Placebo
STARTED   951   954 
COMPLETED   819   789 
NOT COMPLETED   132   165 
Withdrawal by Subject                95                97 
Death                7                8 
Moving                23                42 
Mainly patients lost to follow-up                7                18 

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Candesartan Candesartan cilexetil 32 mg once daily
Placebo Placebo Comparator
Total Total of all reporting groups

Baseline Measures
    Candesartan   Placebo   Total
Overall Participants 
[units: participants]
 951   954   1905 
[units: participants]
<=18 years   0   0   0 
Between 18 and 65 years   951   954   1905 
>=65 years   0   0   0 
[units: years]
Mean (Standard Deviation)
 31.5  (8.5)   31.9  (8.5)   31.7  (8.5) 
[units: participants]
Female   413   401   814 
Male   538   553   1091 
Region of Enrollment 
[units: participants]
Russian Federation   186   162   348 
Europe   595   619   1214 
Canada   69   71   140 
South Africa   101   102   203 

  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale   [ Time Frame: From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year. ]

2.  Secondary:   Number of Participants With a Regression of Diabetic Retinopathy.   [ Time Frame: From baseline to the end of the study, i.e., 5 years ]

3.  Secondary:   Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).   [ Time Frame: From baseline to end of study, i.e. 5 years. ]

4.  Secondary:   Rate of Change in Urinary Albumin Excretion Rate (UAER).   [ Time Frame: From baseline to end of study, i.e. 5 years. ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Niklas Berglind, GPS Atacand
Organization: AstraZeneca
phone: +46 31 7766310

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: AstraZeneca Identifier: NCT00252720     History of Changes
Other Study ID Numbers: D2453C00046
Study First Received: November 10, 2005
Results First Received: March 19, 2012
Last Updated: May 9, 2014
Health Authority: Denmark: Danish Medicines Agency