Comparison · NCT00546754-sae
Losartan 50 mg/HCTZ 12.5 mg vs Valsartan 80 mg/HCTZ 12.5 mg: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Losartan 50 mg/HCTZ 12.5 mg vs Valsartan 80 mg/HCTZ 12.5 mg: serious adverse events. Trial comparisons, record NCT00546754-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00546754-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 | 0.0259 | 0.0145 | 0.0457 | wilson | |
| Risk in group 2 | 0.0131 | 0.00559 | 0.0302 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0128 | -0.00774 | 0.034 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.98 | 0.695 | 5.65 | log | |
| Odds ratio, group 1 over group 2 | 2.01 | 0.692 | 5.83 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Losartan 50 mg/HCTZ 12.5 mg than on Valsartan 80 mg/HCTZ 12.5 mg | 78 | 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 | Losartan 50 mg/HCTZ 12.5 mg | Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure. | 11 | 425 | EG000 |
| Group 2 | Valsartan 80 mg/HCTZ 12.5 mg | Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure. | 5 | 383 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy (0954A-333)
- NCT number
- NCT00546754
- Phases
- PHASE3
- Conditions
- Hypertension
- Interventions
- losartan potassium (+) hydrochlorothiazide, Comparator: Valsartan (+) Hydrochlorothiazide
- Lead sponsor
- Organon and Co
- Results first posted
- 2010-04-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00546754?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.
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