Comparison · NCT01259297-bee033b9
Aliskiren Based Regimen vs Non-Aliskiren Based Regimen: Number of Participants With Composite Cardiovascular Endpoints in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen
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. Aliskiren Based Regimen vs Non-Aliskiren Based Regimen: Number of Participants With Composite Cardiovascular Endpoints in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen. Trial comparisons, record NCT01259297-bee033b9. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01259297-bee033b9
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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 | 0.0128 | 0.00716 | 0.0228 | wilson | |
| Risk in group 2 | 0.0156 | 0.0093 | 0.026 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00278 | -0.0146 | 0.009 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.821 | 0.375 | 1.8 | log | |
| Odds ratio, group 1 over group 2 | 0.819 | 0.37 | 1.81 | log | |
| Number needed to treat, for one fewer participant with the outcome on Aliskiren Based Regimen than on Non-Aliskiren Based Regimen | 359 | 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 | Aliskiren Based Regimen | This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine. | 11 | 860 | OG000 |
| Group 2 | Non-Aliskiren Based Regimen | This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine | 14 | 899 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Composite Cardiovascular Endpoints in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen
- Description
- The composite CV endpoint is based on the following first adjudicated events: CV death, non-fatal MI,non-fatal stroke, significant heart failure
- Time frame
- End of study (209 days (median))
- Population
Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. A total of 25 primary CV composite endpoints had accrued during median follow-up of 209 days versus planned 2000 primary endpoints during planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results.
Source ClinicalTrials.gov
Trial
- Title
- A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People
- NCT number
- NCT01259297
- Phases
- PHASE3
- Conditions
- Cardiovascular Events
- Interventions
- Aliskiren, Amlodipine, Hydrochlorothiazide (HCTZ), Placebo for Aliskiren, Placebo for Amlodipine, Placebo for Hydrochlorothiazide (HCTZ)
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2014-04-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01259297?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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