Trial · NCT00818883
Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone in Participants With Moderate to Severe Hypertension
NCT00818883, 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 in Participants With Moderate to Severe Hypertension. Trials, record NCT00818883. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00818883
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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 in Participants With Moderate to Severe Hypertension
- NCT number
- NCT00818883
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 609 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Essential Hypertension
- Interventions
- Azilsartan medoxomil and chlorthalidone, Azilsartan medoxomil and hydrochlorothiazide
- First posted
- 2009-01-08
- Last updated
- 2012-02-07
- Results first posted
- 2012-02-07
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 Trough, Sitting, Clinic Systolic Blood Pressure | Baseline, Week 6 and Week 10. | The change in sitting trough clinic systolic blood pressure measured at each week indicated including 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 in Trough, Sitting, Clinic Diastolic Blood Pressure | Baseline, Week 6 and Week 10. | The change in sitting trough clinic diastolic blood pressure measured at each week indicated including final visit relative to baseline. Diastolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements. |
| Secondary | Change From Baseline in Mean Trough Systolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 6 and Week 10. | The change in trough systolic blood pressure measured at each week indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 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 (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 6 and Week 10. | The change in trough diastolic blood pressure measured at each week indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 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 6 and Week 10. | The change in 24-hour mean systolic blood pressure measured at each visit indicated including 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 as Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 6 and Week 10. | The change in 24-hour mean diastolic blood pressure measured at each visit indicated including 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 the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 6 and Week 10. | The change in daytime (6am to 10pm) mean systolic blood pressure measured at each visit including 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 and 10 pm. |
| Secondary | Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 6 and Week 10. | The change in daytime (6am to 10pm) mean diastolic blood pressure measured at each visit including 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 and 10 pm. |
| Secondary | Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 6 and Week 10. | The change in nighttime (12am to 6am) mean systolic blood pressure measured at each visit indicated including final visit 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 Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 6 and Week 10. | The change in nighttime (12am to 6am) mean diastolic blood pressure measured at each visit indicated including final visit 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. |
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 Trough, Sitting, Clinic Systolic Blood Pressure | Baseline, Week 6 and Week 10. | Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure | Baseline, Week 6 and Week 10. | Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Trough Systolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 6 and Week 10. | Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 6 and Week 10. | Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 24-hour Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 6 and Week 10. | Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 24-hour Mean Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 6 and Week 10. | Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 6 and Week 10. | Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 6 and Week 10. | Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 6 and Week 10. | Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring. | Baseline, Week 6 and Week 10. | Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | mmHg | LEAST_SQUARES_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group78
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 40 mg/Chlorthalidone 12.5 mg QD | Week 6 (n=295; n=292) | -35.1 | Standard Error 0.97 | mmHg |
| Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Week 6 (n=295; n=292) | -29.5 | Standard Error 0.98 | mmHg |
| Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Week 10 (n=295; n=292) | -37.8 | Standard Error 0.91 | mmHg |
| Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Week 10 (n=295; n=292) | -32.8 | Standard Error 0.91 | mmHg |
| Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Week 6 (n=295; n=292) | -15.0 | Standard Error 0.55 | mmHg |
| Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Week 6 (n=295; n=292) | -11.2 | Standard Error 0.55 | mmHg |
| Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Week 10 (n=295; n=292) | -16.4 | Standard Error 0.50 | mmHg |
| Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Week 10 (n=295; n=292) | -13.7 | Standard Error 0.51 | mmHg |
| Change From Baseline in Mean Trough Systolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring. | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Week 6 (n=179, n=162) | -25.7 | Standard Error 1.11 | mmHg |
| Change From Baseline in Mean Trough Systolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring. | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Week 6 (n=179, n=162) | -18.4 | Standard Error 1.16 | mmHg |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | 303 | |
| Overall Study | STARTED | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | 306 | |
| Overall Study | COMPLETED | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | 252 | |
| Overall Study | COMPLETED | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | 260 | |
| Overall Study | NOT COMPLETED | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | 51 | |
| Overall Study | NOT COMPLETED | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | 46 |
Source ClinicalTrials.gov
Adverse events36
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 40 mg/Chlorthalidone 12.5 mg QD | 38 | 302 | |
| other | Blood creatinine increased | Investigations | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | 27 | 303 | |
| other | Dizziness | Nervous system disorders | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | 37 | 302 | |
| other | Dizziness | Nervous system disorders | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | 32 | 303 | |
| other | Headache | Nervous system disorders | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | 16 | 302 | |
| other | Headache | Nervous system disorders | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | 16 | 303 | |
| serious | Angina unstable | Cardiac disorders | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | 1 | 302 | |
| serious | Angina unstable | Cardiac disorders | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | 0 | 303 | |
| serious | Coronary artery occlusion | Cardiac disorders | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | 1 | 302 | |
| serious | Coronary artery occlusion | Cardiac disorders | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | 0 | 303 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | ||
| Total, all-cause mortality | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | ||
| Total, other adverse events | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | 79 | 302 |
| Total, other adverse events | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | 68 | 303 |
| Total, serious adverse events | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | 6 | 302 |
| Total, serious adverse events | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | 5 | 303 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22939358 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD vs Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD: serious adverse events |
Source 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/NCT00818883
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