Trial · NCT00591578
Efficacy and Safety Comparison of Azilsartan Medoxomil to Valsartan in Participants With Essential Hypertension
NCT00591578, Phase 3, Completed, Takeda; results first posted 2011-04-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Comparison of Azilsartan Medoxomil to Valsartan in Participants With Essential Hypertension. Trials, record NCT00591578. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00591578
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Comparison of Azilsartan Medoxomil to Valsartan in Participants With Essential Hypertension
- NCT number
- NCT00591578
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 984 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Hypertension
- Interventions
- Azilsartan Medoxomil, Azilsartan Medoxomil, Valsartan
- First posted
- 2008-01-11
- Last updated
- 2012-02-02
- Results first posted
- 2011-04-19
- Limitations and caveats
- For the Non-Serious Adverse Event Table, the total number of participants affected is based on the AEs with ≥5% in each phase, calculated separately.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline and Week 24. | The change in 24-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing. |
| Secondary | Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure. | Baseline and Week 24. | The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 24 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements. |
| Secondary | Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline and Week 24. | The change in 24-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing. |
| Secondary | Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure | Baseline and Week 24. | The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 24 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements. |
| Secondary | Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline and Week 24. | The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm. |
| Secondary | Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline and Week 24. | The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm. |
| Secondary | Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline and Week 24. | The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am. |
| Secondary | Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline and Week 24. | The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am. |
| Secondary | Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline and Week 24. | The change in the 12-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing. |
| Secondary | Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline and Week 24. | The change in the 12-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline and Week 24. | Full analysis set with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure. | Baseline and Week 24. | Full analysis set with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline and Week 24. | Full analysis set with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure | Baseline and Week 24. | Full analysis set with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline and Week 24. | Full analysis set with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline and Week 24. | Full analysis set with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline and Week 24. | Full analysis set with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline and Week 24. | Full analysis set with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline and Week 24. | Full analysis set with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline and Week 24. | Full analysis set with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Azilsartan Medoxomil 40 mg QD | -14.93 | Standard Error 0.698 | mmHg | |
| Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Azilsartan Medoxomil 80 mg QD | -15.32 | Standard Error 0.715 | mmHg | |
| Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Valsartan 320 mg QD | -11.29 | Standard Error 0.707 | mmHg | |
| Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure. | Azilsartan Medoxomil 40 mg QD | -14.86 | Standard Error 0.948 | mmHg | |
| Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure. | Azilsartan Medoxomil 80 mg QD | -16.92 | Standard Error 0.966 | mmHg | |
| Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure. | Valsartan 320 mg QD | -11.59 | Standard Error 0.949 | mmHg | |
| Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Azilsartan Medoxomil 40 mg QD | -9.23 | Standard Error 0.459 | mmHg | |
| Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Azilsartan Medoxomil 80 mg QD | -9.77 | Standard Error 0.470 | mmHg | |
| Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Valsartan 320 mg QD | -7.07 | Standard Error 0.465 | mmHg | |
| Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure | Azilsartan Medoxomil 40 mg QD | -7.16 | Standard Error 0.554 | mmHg |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Treatment Phase | STARTED | Azilsartan Medoxomil 40 mg QD | 327 | |
| Double-Blind Treatment Phase | STARTED | Azilsartan Medoxomil 80 mg QD | 329 | |
| Double-Blind Treatment Phase | STARTED | Valsartan 320 mg QD | 328 | |
| Double-Blind Treatment Phase | COMPLETED | Azilsartan Medoxomil 40 mg QD | 249 | |
| Double-Blind Treatment Phase | COMPLETED | Azilsartan Medoxomil 80 mg QD | 249 | |
| Double-Blind Treatment Phase | COMPLETED | Valsartan 320 mg QD | 244 | |
| Double-Blind Treatment Phase | NOT COMPLETED | Azilsartan Medoxomil 40 mg QD | 78 | |
| Double-Blind Treatment Phase | NOT COMPLETED | Azilsartan Medoxomil 80 mg QD | 80 | |
| Double-Blind Treatment Phase | NOT COMPLETED | Valsartan 320 mg QD | 84 | |
| Open-Label Extension Phase | STARTED | Azilsartan Medoxomil 40 mg QD | 55 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events108
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 | Urinary tract infection | Infections and infestations | Azilsartan Medoxomil 40 mg QD | 26 | 327 | |
| other | Urinary tract infection | Infections and infestations | Azilsartan Medoxomil 80 mg QD | 25 | 329 | |
| other | Urinary tract infection | Infections and infestations | Valsartan 320 mg QD | 16 | 326 | |
| other | Urinary tract infection | Infections and infestations | Open Label Extension | 10 | 170 | |
| other | Dizziness | Nervous system disorders | Azilsartan Medoxomil 40 mg QD | 27 | 327 | |
| other | Dizziness | Nervous system disorders | Azilsartan Medoxomil 80 mg QD | 29 | 329 | |
| other | Dizziness | Nervous system disorders | Valsartan 320 mg QD | 15 | 326 | |
| other | Dizziness | Nervous system disorders | Open Label Extension | 8 | 170 | |
| other | Headache | Nervous system disorders | Azilsartan Medoxomil 40 mg QD | 33 | 327 | |
| other | Headache | Nervous system disorders | Azilsartan Medoxomil 80 mg QD | 29 | 329 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Azilsartan Medoxomil 40 mg QD | ||
| Total, all-cause mortality | Azilsartan Medoxomil 80 mg QD | ||
| Total, all-cause mortality | Valsartan 320 mg QD | ||
| Total, all-cause mortality | Open Label Extension | ||
| Total, other adverse events | Azilsartan Medoxomil 40 mg QD | 77 | 327 |
| Total, other adverse events | Azilsartan Medoxomil 80 mg QD | 74 | 329 |
| Total, other adverse events | Valsartan 320 mg QD | 53 | 326 |
| Total, other adverse events | Open Label Extension | 16 | 170 |
| Total, serious adverse events | Azilsartan Medoxomil 40 mg QD | 8 | 327 |
| Total, serious adverse events | Azilsartan Medoxomil 80 mg QD | 5 | 329 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21762358 | RESULT |
Source PubMed
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00591578
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