Trial · NCT00846365
Efficacy and Safety of Azilsartan Medoxomil Plus Chlorthalidone in Participants With Moderate to Severe Hypertension
NCT00846365, Phase 3, Completed, Takeda; results first posted 2012-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Azilsartan Medoxomil Plus Chlorthalidone in Participants With Moderate to Severe Hypertension. Trials, record NCT00846365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00846365
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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 Plus Chlorthalidone in Participants With Moderate to Severe Hypertension
- NCT number
- NCT00846365
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,085 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Essential Hypertension
- Interventions
- Azilsartan medoxomil and chlorthalidone, Azilsartan medoxomil and chlorthalidone, Olmesartan medoxomil-hydrochlorothiazide
- First posted
- 2009-02-18
- Last updated
- 2012-03-13
- Results first posted
- 2012-03-13
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure. | Baseline and Week 8. | The change in trough systolic blood pressure measured at week 8 or final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements. |
| Secondary | Change From Baseline to Week 4 in Trough, Sitting, Clinic Systolic Blood Pressure. | Baseline and Week 4. | The change in trough systolic blood pressure measured at week 4 relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements. |
| Secondary | Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure | Baseline, Week 4 and Week 8. | The change in trough diastolic blood pressure measured at week 4 and week 8 relative to baseline. Diastolic blood pressure is the average of the 3 serial trough sitting diastolic blood pressure measurements. |
| Secondary | Change From Baseline in Trough Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 4 and Week 8. | The change in trough systolic blood pressure measured at week 4 and week 8 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 Trough Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 4 and Week 8. | The change in trough systolic blood pressure measured at week 4 and week 8 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 as Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 4 and Week 8. | The change in the 24-hour mean systolic blood pressure at week4 and week 8 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 Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 4 and Week 8. | The change in the 0 to 24-hours-after-dosing mean diastolic blood pressure measured at Week 4 and Week 8 relative to baseline. . Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average of measurements collected over the subsequent 24 hours. |
| Secondary | Change From Baseline in Daytime Mean (6am to 10pm) Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 4 and Week 8. | The change in the daytime, while awake (6am to 10pm) mean systolic blood pressure measured at Week 4 and Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night Daytime mean is the average of measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive) included in the 24-hour mean calculations. |
| Secondary | Change From Baseline in Daytime Mean (6am to 10pm) Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 4 and Week 8. | The change in the daytime, while awake (6am to 10pm) mean diastolic blood pressure measured at Week 4 and Week 8relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive) included in the 24-hour mean calculations. |
| Secondary | Change From Baseline in Nighttime Mean (12am to 6am) Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring | Baseline, Week 4 and Week 8. | The change in the nighttime, while asleep (12am to 6am) mean systolic blood pressure measured at Week 4 and Week 8 to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive) included in the 24-hour mean calculations. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure. | Baseline 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 to Week 4 in Trough, Sitting, Clinic Systolic Blood Pressure. | Baseline and Week 4. | 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. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough, Sitting, Clinic Diastolic 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. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | 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. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | 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. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 24-hour Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring. | 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. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | 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. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daytime Mean (6am to 10pm) Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | 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. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daytime Mean (6am to 10pm) Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. | 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. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Nighttime Mean (12am to 6am) Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring | 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. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4. | mmHg | LEAST_SQUARES_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure. | Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD | -37.6 | Standard Deviation 0.83 | mmHg | |
| Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure. | Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD | -38.2 | Standard Deviation 0.85 | mmHg | |
| Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure. | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | -31.5 | Standard Deviation 0.84 | mmHg | |
| Change From Baseline to Week 4 in Trough, Sitting, Clinic Systolic Blood Pressure. | Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD | -33.0 | Standard Deviation 0.87 | mmHg | |
| Change From Baseline to Week 4 in Trough, Sitting, Clinic Systolic Blood Pressure. | Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD | -34.1 | Standard Deviation 0.88 | mmHg | |
| Change From Baseline to Week 4 in Trough, Sitting, Clinic Systolic Blood Pressure. | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | -26.9 | Standard Deviation 0.88 | mmHg | |
| Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure | Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD | Week 4 (n=360; n=347; n=352) | -13.6 | Standard Deviation 0.49 | mmHg |
| Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure | Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD | Week 4 (n=360; n=347; n=352) | -14.2 | Standard Deviation 0.50 | mmHg |
| Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Week 4 (n=360; n=347; n=352) | -10.4 | Standard Deviation 0.49 | mmHg |
| Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure | Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD | Week 8 (n=363; n=350; n=353) | -16.1 | Standard Deviation 0.47 | mmHg |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 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 Plus Chlorthalidone 12.5-25 mg QD | 372 | |
| Overall Study | STARTED | Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD | 357 | |
| Overall Study | STARTED | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | 356 | |
| Overall Study | COMPLETED | Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD | 317 | |
| Overall Study | COMPLETED | Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD | 308 | |
| Overall Study | COMPLETED | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | 323 | |
| Overall Study | NOT COMPLETED | Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD | 55 | |
| Overall Study | NOT COMPLETED | Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD | 49 | |
| Overall Study | NOT COMPLETED | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | 33 |
Source ClinicalTrials.gov
Adverse events90
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 | Blood creatinine increased | Investigations | Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD | 36 | 372 | |
| other | Blood creatinine increased | Investigations | Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD | 44 | 357 | |
| other | Blood creatinine increased | Investigations | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | 25 | 356 | |
| other | Dizziness | Nervous system disorders | Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD | 25 | 372 | |
| other | Dizziness | Nervous system disorders | Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD | 24 | 357 | |
| other | Dizziness | Nervous system disorders | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | 20 | 356 | |
| other | Headache | Nervous system disorders | Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD | 14 | 372 | |
| other | Headache | Nervous system disorders | Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD | 14 | 357 | |
| other | Headache | Nervous system disorders | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | 18 | 356 | |
| serious | Cardiac arrest | Cardiac disorders | Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD | 0 | 372 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 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 Plus Chlorthalidone 12.5-25 mg QD | ||
| Total, all-cause mortality | Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD | ||
| Total, all-cause mortality | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | ||
| Total, other adverse events | Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD | 66 | 372 |
| Total, other adverse events | Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD | 72 | 357 |
| Total, other adverse events | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | 56 | 356 |
| Total, serious adverse events | Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD | 4 | 372 |
| Total, serious adverse events | Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD | 8 | 357 |
| Total, serious adverse events | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | 6 | 356 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29334491 | 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.
GET https://conductscience.org/api/trials/v1/NCT00846365
GET https://conductscience.org/api/trials/v1/NCT00846365/results?page=2