With Diabetes Mellitus vs Without Diabetes Mellitus: Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Diabetes Mellitus)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0231 | 0.0177 | 0.0302 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.127 | 0.12 | 0.135 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.104 | -0.114 | -0.0938 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.182 | 0.138 | 0.239 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.162 | 0.122 | 0.216 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on With Diabetes Mellitus than on Without Diabetes Mellitus | 9.6 | 8.78 | 10.7 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
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 | Source |
|---|---|---|---|---|---|---|
| Group 1 | With Diabetes Mellitus | Participants with diabetes mellitus as a complication who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert. | 52 | 2,247 | OG000 | ClinicalTrials.gov |
| Group 2 | Without Diabetes Mellitus | Participants without diabetes mellitus as a complication who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert. | 892 | 7,004 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Diabetes Mellitus) | ClinicalTrials.gov |
| Description | To determine whether having diabetes mellitus as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. | ClinicalTrials.gov |
| Time frame | Last day of observation period (average of 14.76 weeks) | ClinicalTrials.gov |
| Population | The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Amlodipine 10mg Drug Use Investigation | ClinicalTrials.gov |
| NCT number | NCT01252563 | ClinicalTrials.gov |
| Phases | ClinicalTrials.gov | |
| Conditions | Hypertension | ClinicalTrials.gov |
| Interventions | Amlodipine | ClinicalTrials.gov |
| Lead sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | ClinicalTrials.gov |
| Results first posted | 2019-04-02 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01252563?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.