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DIabetic Retinopathy Candesartan Trials. (DIRECT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00252720
First Posted: November 15, 2005
Last Update Posted: June 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Takeda
Information provided by (Responsible Party):
AstraZeneca
Results First Submitted: March 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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The most common reason for not being randomized was that all eligibility criteria were not fulfilled, followed by withdrawn informed consent.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
  Description
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
  Description
Candesartan Candesartan cilexetil 32 mg once daily
Placebo Placebo Comparator
Total Total of all reporting groups

Baseline Measures
   Candesartan   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 951   954   1905 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   951   954   1905 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.5  (8.5)   31.9  (8.5)   31.7  (8.5) 
Gender 
[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
e-mail: ClinicalTrialTransparency@astrazeneca.com


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00252720     History of Changes
Other Study ID Numbers: D2453C00046
DIRECT
SH-AHM-0046
First Submitted: November 10, 2005
First Posted: November 15, 2005
Results First Submitted: March 19, 2012
Results First Posted: June 3, 2014
Last Update Posted: June 3, 2014