Comparison · NCT00818883-sae
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD vs Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD: 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 40 mg/Chlorthalidone 12.5 mg QD vs Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD: serious adverse events. Trial comparisons, record NCT00818883-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00818883-sae
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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 | 0.0199 | 0.00914 | 0.0427 | wilson | |
| Risk in group 2 | 0.0165 | 0.00707 | 0.038 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00337 | -0.0207 | 0.028 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.2 | 0.371 | 3.9 | log | |
| Odds ratio, group 1 over group 2 | 1.21 | 0.365 | 4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD than on Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | 297 | 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 40 mg/Chlorthalidone 12.5 mg QD | Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment. | 6 | 302 | EG000 |
| Group 2 | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment. | 5 | 303 | 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 double-blind study drug.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone in Participants With Moderate to Severe Hypertension
- NCT number
- NCT00818883
- Phases
- PHASE3
- Conditions
- Essential Hypertension
- Interventions
- Azilsartan medoxomil and chlorthalidone, Azilsartan medoxomil and hydrochlorothiazide
- Lead sponsor
- Takeda
- Results first posted
- 2012-02-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00818883?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
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