Comparison · NCT00407537-sae
Caduet vs Usual Care: 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. Caduet vs Usual Care: serious adverse events. Trial comparisons, record NCT00407537-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00407537-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 | 0.0655 | 0.0501 | 0.0851 | wilson | |
| Risk in group 2 | 0.0323 | 0.0214 | 0.0484 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0332 | 0.011 | 0.0556 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.03 | 1.24 | 3.31 | log | |
| Odds ratio, group 1 over group 2 | 2.1 | 1.26 | 3.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Caduet than on Usual Care | 30.1 | 18 | 91.1 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: usual care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Caduet | Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion. | 51 | 779 | EG000 |
| Group 2 | Usual Care | Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice. | 22 | 682 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors
- NCT number
- NCT00407537
- Phases
- PHASE4
- Conditions
- Hypertension, Hypercholesterolemia
- Interventions
- Amlodipine besylate/atorvastatin calcium single pill combination
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2011-11-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00407537?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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