Trial · NCT01033071
Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Moderate to Severe Hypertension.
NCT01033071, Phase 3, Completed, Takeda; results first posted 2012-02-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Moderate to Severe Hypertension. Trials, record NCT01033071. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01033071
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Moderate to Severe Hypertension.
- NCT number
- NCT01033071
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,071 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Essential Hypertension
- Interventions
- Azilsartan medoxomil and chlorthalidone, Azilsartan medoxomil and chlorthalidone, Olmesartan medoxomil and hydrochlorothiazide
- First posted
- 2009-12-16
- Last updated
- 2012-02-07
- Results first posted
- 2012-02-07
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Baseline and Week 12. | The change in sitting trough clinic systolic blood pressure measured at week 12 or final visit relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements. |
| Secondary | Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Baseline, Week 4 and Week 8. | The change in sitting trough clinic systolic blood pressure measured at each week indicated relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements. |
| Secondary | Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure. | Baseline, Week 4, Week 8 and Week 12. | The change in sitting trough clinic diastolic blood pressure measured at each week indicated relative to baseline. Trough blood pressure is the average (arithmetic mean) of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements. |
| Secondary | Change From Baseline in Mean Trough Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change in trough systolic blood pressure measured at week 12 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing. |
| Secondary | Change From Baseline in Mean Trough Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change in trough diastolic blood pressure measured at week 12 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing. |
| Secondary | Change From Baseline in 24-hour Mean Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change in 24-hour mean systolic blood pressure measured at week 12 or final visit 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 24-hour Mean Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change in 24-hour mean diastolic blood pressure measured at week 12 or final visit 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 Daytime (6 AM to 10 PM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 12 or final visit 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 (inclusive) and 10 PM (exclusive). |
| Secondary | Change From Baseline in Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 12 or final visit 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 (inclusive) and 10 PM (exclusive). |
| Secondary | Change From Baseline in Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change in the mean nighttime (12am to 6am) systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Mean nighttime is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive). |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
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 Trough, Sitting, Clinic Systolic Blood Pressure. | Baseline and Week 12. | Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Baseline, Week 4 and Week 8. | Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure. | Baseline, Week 4, Week 8 and Week 12. | Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Trough Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Trough Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 24-hour Mean Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 24-hour Mean Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group219
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 Trough, Sitting, Clinic Systolic Blood Pressure. | Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | -42.5 | Standard Error 0.81 | mmHg | |
| Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | -44.0 | Standard Error 0.83 | mmHg | |
| Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | -37.1 | Standard Error 0.80 | mmHg | |
| Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Week 4 (n=343; n=330; n=352) | -34.7 | Standard Error 0.77 | mmHg |
| Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Week 4 (n=343; n=330; n=352) | -36.7 | Standard Error 0.79 | mmHg |
| Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Week 4 (n=343; n=330; n=352) | -29.7 | Standard Error 0.76 | mmHg |
| Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Week 8 (n=344; n=330; n=353) | -39.1 | Standard Error 0.78 | mmHg |
| Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Week 8 (n=344; n=330; n=353) | -39.4 | Standard Error 0.80 | mmHg |
| Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Week 8 (n=344; n=330; n=353) | -33.5 | Standard Error 0.77 | mmHg |
| Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure. | Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Week 4 (n=343; n=330; n=352) | -14.9 | Standard Error 0.46 | mmHg |
1 to 10 of 219Source ClinicalTrials.gov
See all 219 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | 355 | |
| Overall Study | STARTED | Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | 352 | |
| Overall Study | STARTED | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | 364 | |
| Overall Study | COMPLETED | Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | 300 | |
| Overall Study | COMPLETED | Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | 275 | |
| Overall Study | COMPLETED | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | 317 | |
| Overall Study | NOT COMPLETED | Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | 55 | |
| Overall Study | NOT COMPLETED | Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | 77 | |
| Overall Study | NOT COMPLETED | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | 47 |
Source ClinicalTrials.gov
Adverse events105
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 | Fatigue | General disorders | Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | 33 | 355 | |
| other | Fatigue | General disorders | Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | 14 | 352 | |
| other | Fatigue | General disorders | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | 16 | 364 | |
| other | Blood creatinine increased | Investigations | Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | 66 | 355 | |
| other | Blood creatinine increased | Investigations | Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | 78 | 352 | |
| other | Blood creatinine increased | Investigations | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | 34 | 364 | |
| other | Blood uric acid increased | Investigations | Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | 19 | 355 | |
| other | Blood uric acid increased | Investigations | Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | 17 | 352 | |
| other | Blood uric acid increased | Investigations | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | 12 | 364 | |
| other | Dizziness | Nervous system disorders | Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | 41 | 355 |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | ||
| Total, all-cause mortality | Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | ||
| Total, all-cause mortality | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | ||
| Total, other adverse events | Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | 141 | 355 |
| Total, other adverse events | Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | 144 | 352 |
| Total, other adverse events | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | 94 | 364 |
| Total, serious adverse events | Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | 1 | 355 |
| Total, serious adverse events | Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | 10 | 352 |
| Total, serious adverse events | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | 8 | 364 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22710649 | DERIVED |
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT01033071/results?page=2