Comparison · NCT01302691-sae
L50/H12.5/A5 vs L50 + A5: 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. L50/H12.5/A5 vs L50 + A5: serious adverse events. Trial comparisons, record NCT01302691-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01302691-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 | 0.0061 | 0.00108 | 0.0337 | wilson | |
| Risk in group 2 | 0.00613 | 0.00108 | 0.0339 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0000374 | -0.0283 | 0.028 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.994 | 0.0627 | 15.8 | log | |
| Odds ratio, group 1 over group 2 | 0.994 | 0.0616 | 16 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on L50/H12.5/A5 than on L50 + A5 | 26,700 | 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 | L50/H12.5/A5 | Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks. | 1 | 164 | EG000 |
| Group 2 | L50 + A5 | Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks. | 1 | 163 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- up to 2 weeks after last dose of study drug (up to 10 weeks)
Source ClinicalTrials.gov
Trial
- Title
- MK-0954E Study in Participants With Hypertension (MK-0954E-357)
- NCT number
- NCT01302691
- Phases
- PHASE3
- Conditions
- Hypertension
- Interventions
- losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E), Losartan potassium, Amlodipine besylate, Placebo to MK-0954E, Placebo to losartan potassium, Placebo to amlodipine besylate
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2017-01-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01302691?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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