DIabetic Retinopathy Candesartan Trials. (DIRECT)

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00252720
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The most common reason for not being randomized was that all eligibility criteria were not fulfilled, followed by withdrawn informed consent.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
  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  
Number of Participants  
[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
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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


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00252720     History of Changes
Other Study ID Numbers: D2453C00046, DIRECT, SH-AHM-0046
Study First Received: November 10, 2005
Results First Received: March 19, 2012
Last Updated: May 9, 2014
Health Authority: Denmark: Danish Medicines Agency