Trial · NCT00252694
DIabetic Retinopathy Candesartan Trials
NCT00252694, Phase 3, Completed, AstraZeneca; results first posted 2014-06-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. DIabetic Retinopathy Candesartan Trials. Trials, record NCT00252694. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00252694
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DIabetic Retinopathy Candesartan Trials
- NCT number
- NCT00252694
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,717 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Type 2 Diabetes
- Interventions
- candesartan
- First posted
- 2005-11-15
- Last updated
- 2014-06-06
- Results first posted
- 2014-06-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale | From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year. | 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments. |
| Secondary | Number of Participants With at Least a 3 Step Improvement or a Persistent 2-step Improvement in the ETDRS Severity Scale. | From baseline to end of study, i.e. 5 years. | 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). |
| Secondary | Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR). | From baseline to end of study, i.e. 5 years. | Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs. |
| Secondary | Rate of Change in Urinary Albumin Excretion Rate (UAER). | From Baseline to end of study, i.e. 5 years. | An estimate of the slope from fitting a linear regression of log(UAER) over time (post-randomisation, yearly assessments) for each patient. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale | From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year. | The population was the Intention To Treat population which includes all randomized patients with any post-randomization data. | Participants | NUMBER |
| SECONDARY | Number of Participants With at Least a 3 Step Improvement or a Persistent 2-step Improvement in the ETDRS Severity Scale. | From baseline to end of study, i.e. 5 years. | The population was the Intention To Treat population which includes all randomized patients with any post-randomization data. | Participants | NUMBER |
| SECONDARY | Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR). | From baseline to end of study, i.e. 5 years. | The population was the Intention To Treat population which includes all randomized patients with any post-randomization data. | Participants | NUMBER |
| SECONDARY | Rate of Change in Urinary Albumin Excretion Rate (UAER). | From Baseline to end of study, i.e. 5 years. | The population was the Intention To Treat population which includes all randomized patients with any post-randomization data. | log (µg/min)/1000 year | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale | Candesartan | 161 | 0.045 | Participants | |
| Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale | Placebo | 182 | 0.052 | Participants | |
| Number of Participants With at Least a 3 Step Improvement or a Persistent 2-step Improvement in the ETDRS Severity Scale. | Candesartan | 180 | 0.054 | Participants | |
| Number of Participants With at Least a 3 Step Improvement or a Persistent 2-step Improvement in the ETDRS Severity Scale. | Placebo | 136 | 0.040 | Participants | |
| Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR). | Candesartan | 192 | 0.06 | Participants | |
| Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR). | Placebo | 193 | 0.06 | Participants | |
| Rate of Change in Urinary Albumin Excretion Rate (UAER). | Candesartan | 656 | 95% Confidence Interval 605 to 708 | log (µg/min)/1000 year | |
| Rate of Change in Urinary Albumin Excretion Rate (UAER). | Placebo | 718 | 95% Confidence Interval 666 to 770 | log (µg/min)/1000 year |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Candesartan | 951 | |
| Overall Study | STARTED | Placebo | 954 | |
| Overall Study | COMPLETED | Candesartan | 807 | |
| Overall Study | COMPLETED | Placebo | 800 | |
| Overall Study | NOT COMPLETED | Candesartan | 144 | |
| Overall Study | NOT COMPLETED | Placebo | 154 |
Source ClinicalTrials.gov
Adverse events758
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypotension | Vascular disorders | Candesartan | 50 | 949 | |
| other | Hypotension | Vascular disorders | Placebo | 18 | 953 | |
| serious | Anaemia | Blood and lymphatic system disorders | Candesartan | 2 | 949 | |
| serious | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 953 | |
| serious | Disseminated Intravascular Coagulation | Blood and lymphatic system disorders | Candesartan | 1 | 949 | |
| serious | Disseminated Intravascular Coagulation | Blood and lymphatic system disorders | Placebo | 0 | 953 | |
| serious | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Candesartan | 0 | 949 | |
| serious | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 953 | |
| serious | Myocardial Infarction | Cardiac disorders | Candesartan | 19 | 949 | |
| serious | Myocardial Infarction | Cardiac disorders | Placebo | 18 | 953 |
1 to 10 of 758Source ClinicalTrials.gov
See all 758 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Candesartan | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Candesartan | 50 | 949 |
| Total, other adverse events | Placebo | 18 | 953 |
| Total, serious adverse events | Candesartan | 301 | 949 |
| Total, serious adverse events | Placebo | 267 | 953 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Candesartan vs Placebo: Number of Participants With at Least a 3 Step Improvement or a Persistent 2-step Improvement in the ETDRS Severity Scale. | Trial comparisons |
| Candesartan vs Placebo: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale | Trial comparisons |
| Candesartan vs Placebo: Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR). | Trial comparisons |
| Candesartan vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00252694
GET https://conductscience.org/api/trials/v1/NCT00252694/events?page=2