Trial · NCT02092025
Azilsartan Tablets Special Drug Use Surveillance: Long-term Use
NCT02092025, Completed, Takeda; results first posted 2019-01-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Azilsartan Tablets Special Drug Use Surveillance: Long-term Use. Trials, record NCT02092025. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02092025
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Azilsartan Tablets Special Drug Use Surveillance: Long-term Use
- NCT number
- NCT02092025
- Status
- Completed
- Enrollment
- 3,437 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Hypertension
- Interventions
- Azilsartan
- First posted
- 2014-03-19
- Last updated
- 2019-01-15
- Results first posted
- 2019-01-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | Up to 12 Months | ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. |
| Secondary | Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Baseline, Month 1 and final assessment (up to 12 Months) | Reported data are changes in SBP from baseline at Month 1 and final assessment (up to 12 months). |
| Secondary | Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point | Baseline, Month 1 and Final assessment (up to 12 Months) | Reported data are changes in DBP from baseline at Month 1 and final assessment (up to 12 months). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | Up to 12 Months | Safety Analysis set included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Baseline, Month 1 and final assessment (up to 12 Months) | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given time point. | mmHg | MEAN |
| SECONDARY | Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point | Baseline, Month 1 and Final assessment (up to 12 Months) | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given time point. | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | Azilsartan | 94 | Participants | ||
| Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Azilsartan | Change in SBP at Month 1 | -15.4 | Standard Deviation 19.99 | mmHg |
| Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Azilsartan | Change in SBP at Final Assessment | -19.8 | Standard Deviation 22.80 | mmHg |
| Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point | Azilsartan | Change in DBP at Month 1 | -7.7 | Standard Deviation 12.55 | mmHg |
| Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point | Azilsartan | Change in DBP at Final Assessment | -10.3 | Standard Deviation 13.91 | mmHg |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Azilsartan | 3,437 | |
| Overall Study | COMPLETED | Azilsartan | 3,369 | |
| Overall Study | NOT COMPLETED | Azilsartan | 68 |
Source ClinicalTrials.gov
Adverse events15
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 | Dizziness | Nervous system disorders | Azilsartan | 15 | 3,369 | |
| serious | Decreased appetite | Metabolism and nutrition disorders | Azilsartan | 1 | 3,369 | |
| serious | Cerebral infarction | Nervous system disorders | Azilsartan | 1 | 3,369 | |
| serious | Loss of consciousness | Nervous system disorders | Azilsartan | 1 | 3,369 | |
| serious | Prinzmetal angina | Cardiac disorders | Azilsartan | 1 | 3,369 | |
| serious | Sinus arrest | Cardiac disorders | Azilsartan | 1 | 3,369 | |
| serious | Bradycardia | Cardiac disorders | Azilsartan | 1 | 3,369 | |
| serious | Cardiac failure | Cardiac disorders | Azilsartan | 1 | 3,369 | |
| serious | Ileus | Gastrointestinal disorders | Azilsartan | 1 | 3,369 | |
| serious | Bile duct stone | Hepatobiliary disorders | Azilsartan | 1 | 3,369 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Azilsartan | ||
| Total, other adverse events | Azilsartan | 15 | 3,369 |
| Total, serious adverse events | Azilsartan | 10 | 3,369 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02092025
GET https://conductscience.org/api/trials/v1/NCT02092025/registered