Comparison · NCT01966107-0c420b31
Aclidinium Bromide vs Placebo: Number of Participants With Major Adverse Cardiovascular Event (MACE) - on Study Analysis
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. Aclidinium Bromide vs Placebo: Number of Participants With Major Adverse Cardiovascular Event (MACE) - on Study Analysis. Trial comparisons, record NCT01966107-0c420b31. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01966107-0c420b31
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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 | 0.0385 | 0.0306 | 0.0485 | wilson | |
| Risk in group 2 | 0.0423 | 0.0339 | 0.0526 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00374 | -0.0168 | 0.00925 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.911 | 0.662 | 1.25 | log | |
| Odds ratio, group 1 over group 2 | 0.908 | 0.651 | 1.27 | log | |
| Number needed to treat, for one fewer participant with the outcome on Aclidinium Bromide than on Placebo | 267 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Aclidinium Bromide | Randomized subjects were administered Aclidinium bromide 400 μg BID, once in the morning and once in the evening (approximately 12 hours apart), via a multi-dose dry powder inhalation device (DPI). Subjects on a LAMA (long-acting muscarinic antagonist i.e., inhaled anticholinergics) had to washout 2 weeks prior to randomization. | 69 | 1,791 | OG000 |
| Group 2 | Placebo | Randomized subjects were administered placebo, once in the morning and once in the evening (approximately 12 hours apart), via a multi-dose DPI. Subjects on a LAMA (ie, inhaled anticholinergics) had to washout 2 weeks prior to randomization. | 76 | 1,798 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Major Adverse Cardiovascular Event (MACE) - on Study Analysis
- Description
To assess the cardiovascular (CV) safety of aclidinium bromide on MACEs. The number of subjects with an adjudicated composite MACE with treatment group, baseline CV severity, and smoking status as factors. MACE for the analyses was defined as any adjudicated event which was a composite of the total of CV death, non-fatal myocardial infarction (MI), or non-fatal stroke (on-study analysis).
- Time frame
- At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU)
- Population
The Full Analysis Set (FAS) population consisted of all subjects in the Randomized Population who took at least one dose of the double-blind IP (aclidinium bromide or placebo). Subjects were analyzed according to their randomized treatment.
Source ClinicalTrials.gov
Trial
- Title
- Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients.
- NCT number
- NCT01966107
- Phases
- PHASE4
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease, Moderate to Very Severe COPD
- Interventions
- Aclidinium Bromide, Placebo
- Lead sponsor
- AstraZeneca
- Results first posted
- 2018-12-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01966107?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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