Trial · NCT00996281
Safety and Tolerability of Azilsartan Medoxomil Plus Chlorthalidone Compared to Olmesartan Medoxomil Plus Hydrochlorothiazide in Participants With Essential Hypertension
NCT00996281, Phase 3, Completed, Takeda; results first posted 2012-11-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability of Azilsartan Medoxomil Plus Chlorthalidone Compared to Olmesartan Medoxomil Plus Hydrochlorothiazide in Participants With Essential Hypertension. Trials, record NCT00996281. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00996281
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of Azilsartan Medoxomil Plus Chlorthalidone Compared to Olmesartan Medoxomil Plus Hydrochlorothiazide in Participants With Essential Hypertension
- NCT number
- NCT00996281
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 837 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Essential Hypertension
- Interventions
- Azilsartan medoxomil and chlorthalidone, Olmesartan medoxomil and hydrochlorothiazide
- First posted
- 2009-10-16
- Last updated
- 2012-11-12
- Other registries' IDs
- eudract:2008-008260-28
- Results first posted
- 2012-11-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With at Least 1 Adverse Event | From Week 0 (Day 1) to Week 52. | An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product without regard to causality. |
| Secondary | Percentage of Participants With Serum Creatinine Elevations Greater Than 50% From Baseline and Greater Than the Upper Limit of Normal (ULN) | Baseline and Week 52 | Serum creatinine was measured at every visit and evaluated as a laboratory parameter of special interest. The percentage of participants with creatinine increase ≥50% from Baseline and greater than ULN was summarized: - At any visit (includes transient and persistent elevations). - At the Final Visit (includes persistent elevations and participants whose first elevation may have been at the Final Visit). - At least 2 consecutive visits (includes only persistent elevations). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With at Least 1 Adverse Event | From Week 0 (Day 1) to Week 52. | Safety analysis set: All participants who received at least 1 dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Serum Creatinine Elevations Greater Than 50% From Baseline and Greater Than the Upper Limit of Normal (ULN) | Baseline and Week 52 | Safety analysis set. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With at Least 1 Adverse Event | Azilsartan Medoxomil and Chlorthalidone | 78.5 | percentage of participants | ||
| Percentage of Participants With at Least 1 Adverse Event | Olmesartan Medoxomil and Hydrochlorothiazide | 76.4 | percentage of participants | ||
| Percentage of Participants With Serum Creatinine Elevations Greater Than 50% From Baseline and Greater Than the Upper Limit of Normal (ULN) | Azilsartan Medoxomil and Chlorthalidone | At any postbaseline visit | 14.2 | percentage of participants | |
| Percentage of Participants With Serum Creatinine Elevations Greater Than 50% From Baseline and Greater Than the Upper Limit of Normal (ULN) | Olmesartan Medoxomil and Hydrochlorothiazide | At any postbaseline visit | 5.8 | percentage of participants | |
| Percentage of Participants With Serum Creatinine Elevations Greater Than 50% From Baseline and Greater Than the Upper Limit of Normal (ULN) | Azilsartan Medoxomil and Chlorthalidone | at the Final Visit | 5.9 | percentage of participants | |
| Percentage of Participants With Serum Creatinine Elevations Greater Than 50% From Baseline and Greater Than the Upper Limit of Normal (ULN) | Olmesartan Medoxomil and Hydrochlorothiazide | at the Final Visit | 1.0 | percentage of participants | |
| Percentage of Participants With Serum Creatinine Elevations Greater Than 50% From Baseline and Greater Than the Upper Limit of Normal (ULN) | Azilsartan Medoxomil and Chlorthalidone | ≥2 consecutive elevations | 5.1 | percentage of participants | |
| Percentage of Participants With Serum Creatinine Elevations Greater Than 50% From Baseline and Greater Than the Upper Limit of Normal (ULN) | Olmesartan Medoxomil and Hydrochlorothiazide | ≥2 consecutive elevations | 1.2 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Azilsartan Medoxomil and Chlorthalidone | 418 | |
| Overall Study | STARTED | Olmesartan Medoxomil and Hydrochlorothiazide | 419 | |
| Overall Study | COMPLETED | Azilsartan Medoxomil and Chlorthalidone | 287 | |
| Overall Study | COMPLETED | Olmesartan Medoxomil and Hydrochlorothiazide | 330 | |
| Overall Study | NOT COMPLETED | Azilsartan Medoxomil and Chlorthalidone | 131 | |
| Overall Study | NOT COMPLETED | Olmesartan Medoxomil and Hydrochlorothiazide | 89 |
Source ClinicalTrials.gov
Adverse events158
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 | Diarrhoea | Gastrointestinal disorders | Azilsartan Medoxomil and Chlorthalidone | 20 | 418 | |
| other | Diarrhoea | Gastrointestinal disorders | Olmesartan Medoxomil and Hydrochlorothiazide | 21 | 419 | |
| other | Nausea | Gastrointestinal disorders | Azilsartan Medoxomil and Chlorthalidone | 20 | 418 | |
| other | Nausea | Gastrointestinal disorders | Olmesartan Medoxomil and Hydrochlorothiazide | 21 | 419 | |
| other | Fatigue | General disorders | Azilsartan Medoxomil and Chlorthalidone | 21 | 418 | |
| other | Fatigue | General disorders | Olmesartan Medoxomil and Hydrochlorothiazide | 17 | 419 | |
| other | Nasopharyngitis | Infections and infestations | Azilsartan Medoxomil and Chlorthalidone | 51 | 418 | |
| other | Nasopharyngitis | Infections and infestations | Olmesartan Medoxomil and Hydrochlorothiazide | 48 | 419 | |
| other | Upper respiratory tract infection | Infections and infestations | Azilsartan Medoxomil and Chlorthalidone | 20 | 418 | |
| other | Upper respiratory tract infection | Infections and infestations | Olmesartan Medoxomil and Hydrochlorothiazide | 27 | 419 |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Azilsartan Medoxomil and Chlorthalidone | ||
| Total, all-cause mortality | Olmesartan Medoxomil and Hydrochlorothiazide | ||
| Total, other adverse events | Azilsartan Medoxomil and Chlorthalidone | 217 | 418 |
| Total, other adverse events | Olmesartan Medoxomil and Hydrochlorothiazide | 183 | 419 |
| Total, serious adverse events | Azilsartan Medoxomil and Chlorthalidone | 24 | 418 |
| Total, serious adverse events | Olmesartan Medoxomil and Hydrochlorothiazide | 26 | 419 |
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 |
|---|
| Azilsartan Medoxomil and Chlorthalidone vs Olmesartan Medoxomil and Hydrochlorothiazide: 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/NCT00996281
GET https://conductscience.org/api/trials/v1/NCT00996281/events?page=2