Comparison · NCT00996281-sae
Azilsartan Medoxomil and Chlorthalidone vs Olmesartan Medoxomil and Hydrochlorothiazide: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Azilsartan Medoxomil and Chlorthalidone vs Olmesartan Medoxomil and Hydrochlorothiazide: serious adverse events. Trial comparisons, record NCT00996281-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00996281-sae
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0574 | 0.0389 | 0.084 | wilson | |
| Risk in group 2 | 0.0621 | 0.0427 | 0.0894 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00464 | -0.0376 | 0.0283 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.925 | 0.54 | 1.58 | log | |
| Odds ratio, group 1 over group 2 | 0.921 | 0.52 | 1.63 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Azilsartan Medoxomil and Chlorthalidone than on Olmesartan Medoxomil and Hydrochlorothiazide | 216 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Azilsartan Medoxomil and Chlorthalidone | Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control. | 24 | 418 | EG000 |
| Group 2 | Olmesartan Medoxomil and Hydrochlorothiazide | Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control. | 26 | 419 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of study drug.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Tolerability of Azilsartan Medoxomil Plus Chlorthalidone Compared to Olmesartan Medoxomil Plus Hydrochlorothiazide in Participants With Essential Hypertension
- NCT number
- NCT00996281
- Phases
- PHASE3
- Conditions
- Essential Hypertension
- Interventions
- Azilsartan medoxomil and chlorthalidone, Olmesartan medoxomil and hydrochlorothiazide
- Lead sponsor
- Takeda
- Results first posted
- 2012-11-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00996281?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00996281-sae