Comparison · NCT00666536-sae
Aggressive Treatment Regimen (5/320 mg to 10/320 mg) vs Moderate Treatment Regimen (5/160 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. Aggressive Treatment Regimen (5/320 mg to 10/320 mg) vs Moderate Treatment Regimen (5/160 mg): serious adverse events. Trial comparisons, record NCT00666536-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00666536-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 | 0.0108 | 0.00422 | 0.0275 | wilson | |
| Risk in group 2 | 0.0279 | 0.0152 | 0.0505 | wilson | |
| Risk difference, group 1 minus group 2 | -0.017 | -0.0406 | 0.00394 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.389 | 0.123 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | 0.382 | 0.119 | 1.23 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Aggressive Treatment Regimen (5/320 mg to 10/320 mg) than on Moderate Treatment Regimen (5/160 mg) | 58.8 | 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 | Aggressive Treatment Regimen (5/320 mg to 10/320 mg) | Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks) | 4 | 369 | EG000 |
| Group 2 | Moderate Treatment Regimen (5/160 mg) | Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks) | 10 | 359 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 12 weeks
Source ClinicalTrials.gov
Trial
- Title
- The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy
- NCT number
- NCT00666536
- Phases
- PHASE4
- Conditions
- Hypertension
- Interventions
- valsartan and amlodipine, valsartan and amlodipine
- Lead sponsor
- Novartis
- Results first posted
- 2010-12-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00666536?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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