Comparison · NCT01107743-ef89a04a
Without Familial Hypercholesterolemia vs With Familial Hypercholesterolemia: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia.
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. Without Familial Hypercholesterolemia vs With Familial Hypercholesterolemia: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia. Trial comparisons, record NCT01107743-ef89a04a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01107743-ef89a04a
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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 | 0.0146 | 0.00927 | 0.023 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000139 | 0.215 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0146 | -0.201 | 0.023 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Without Familial Hypercholesterolemia than on With Familial Hypercholesterolemia | 68.4 | 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 | Without Familial Hypercholesterolemia | Participants without Familial Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert. | 18 | 1,231 | OG000 |
| Group 2 | With Familial Hypercholesterolemia | Participants with Familial Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert. | 0 | 14 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia.
- Description
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Familial Hypercholesterolemia is significant risk factor.
- Time frame
- 8 weeks
- Population
- The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
Source ClinicalTrials.gov
Trial
- Title
- Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
- NCT number
- NCT01107743
- Phases
- Conditions
- Hypertension, Angina Pectoris, Hypercholesterolemia, Familial Hypercholesterolemia
- Interventions
- Amlodipine/Atorvastatin
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2013-05-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01107743?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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