Trial · NCT00695955
One-Year Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension
NCT00695955, Phase 3, Completed, Takeda; results first posted 2011-04-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. One-Year Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension. Trials, record NCT00695955. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00695955
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- One-Year Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension
- NCT number
- NCT00695955
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 669 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Hypertension
- Interventions
- Azilsartan medoxomil with or without add-on chlorthalidone, Azilsartan medoxomil with or without add-on hydrochlorothiazide
- First posted
- 2008-06-12
- Last updated
- 2011-04-19
- Results first posted
- 2011-04-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1. | 56 weeks. | Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug. |
| Primary | Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2. | 56 weeks. | Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug. |
| Secondary | Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1. | 52 weeks | The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit. |
| Secondary | Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2 | 52 weeks | The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit. |
| Secondary | Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1. | 52 weeks. | The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit. |
| Secondary | Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2. | 52 weeks. | The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1. | 56 weeks. | Full Analysis Set. | participants | NUMBER |
| PRIMARY | Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2. | 56 weeks. | Full Analysis Set. | participants | NUMBER |
| SECONDARY | Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1. | 52 weeks | Full Analysis Set. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2 | 52 weeks | Full Analysis Set. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1. | 52 weeks. | Full Analysis Set. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2. | 52 weeks. | Full Analysis Set. | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1. | Cohort 1 | Number of Participants | 267 | participants | |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1. | Cohort 1 | Percentage of Participants | 73.8 | participants | |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2. | Cohort 2 | Number of Participants | 241 | participants | |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2. | Cohort 2 | Percentage of Participants | 78.5 | participants | |
| Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1. | Cohort 1 | Week 4 | -10.1 | Standard Deviation 15.21 | mmHg |
| Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1. | Cohort 1 | Week 8 | -13.1 | Standard Deviation 16.72 | mmHg |
| Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1. | Cohort 1 | Week 12 | -21.5 | Standard Deviation 15.80 | mmHg |
| Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1. | Cohort 1 | Week 16 | -25.4 | Standard Deviation 15.09 | mmHg |
| Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1. | Cohort 1 | Week 26 | -26.3 | Standard Deviation 15.97 | mmHg |
| Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1. | Cohort 1 | Week 36 | -27.3 | Standard Deviation 16.63 | mmHg |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Cohort 1 | STARTED | Azilsartan Medoxomil | 362 | |
| Cohort 1 | COMPLETED | Azilsartan Medoxomil | 260 | |
| Cohort 1 | NOT COMPLETED | Azilsartan Medoxomil | 102 | |
| Cohort 2 | STARTED | Azilsartan Medoxomil | 307 | |
| Cohort 2 | COMPLETED | Azilsartan Medoxomil | 203 | |
| Cohort 2 | NOT COMPLETED | Azilsartan Medoxomil | 104 |
Source ClinicalTrials.gov
Adverse events134
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 | Cohort 1 | 52 | 362 | |
| other | Dizziness | Nervous system disorders | Cohort 2 | 44 | 307 | |
| other | Headache | Nervous system disorders | Cohort 1 | 38 | 362 | |
| other | Headache | Nervous system disorders | Cohort 2 | 28 | 307 | |
| other | Fatigue | General disorders | Cohort 1 | 32 | 362 | |
| other | Fatigue | General disorders | Cohort 2 | 16 | 307 | |
| other | Upper respiratory tract infection | Infections and infestations | Cohort 1 | 25 | 362 | |
| other | Upper respiratory tract infection | Infections and infestations | Cohort 2 | 20 | 307 | |
| other | Urinary tract infection | Infections and infestations | Cohort 1 | 26 | 362 | |
| other | Urinary tract infection | Infections and infestations | Cohort 2 | 11 | 307 |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | ||
| Total, all-cause mortality | Cohort 2 | ||
| Total, other adverse events | Cohort 1 | 134 | 362 |
| Total, other adverse events | Cohort 2 | 106 | 307 |
| Total, serious adverse events | Cohort 1 | 30 | 362 |
| Total, serious adverse events | Cohort 2 | 22 | 307 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cohort 1 vs Cohort 2: 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/NCT00695955
GET https://conductscience.org/api/trials/v1/NCT00695955/results?page=2