Comparison · NCT01259297-053f582f
Aliskiren+Amlodipine/HCTZ Group vs Placebo: Number of Participants With Composite Cardiovascular Endpoints in Aliskiren+Amlodipine/HCTZ Group Versus All Placebo Group
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+Amlodipine/HCTZ Group vs Placebo: Number of Participants With Composite Cardiovascular Endpoints in Aliskiren+Amlodipine/HCTZ Group Versus All Placebo Group. Trial comparisons, record NCT01259297-053f582f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01259297-053f582f
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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 | 0.00462 | 0.00127 | 0.0167 | wilson | |
| Risk in group 2 | 0.0177 | 0.009 | 0.0345 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0131 | -0.0302 | 0.0018 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.261 | 0.0557 | 1.22 | log | |
| Odds ratio, group 1 over group 2 | 0.258 | 0.0544 | 1.22 | log | |
| Number needed to treat, for one fewer participant with the outcome on Aliskiren+Amlodipine/HCTZ Group than on Placebo | 76.5 | 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 | Aliskiren+Amlodipine/HCTZ Group | This reporting group includes all the patients who has received Aliskiren plus an additional BP lowering drug (Amlodipine or Hydrochlorothiazide). This reporting group includes patients from arms such as Aliskiren + Hydrochlorothiazide (HCTZ) and Aliskiren + Amlodipine. | 2 | 433 | OG000 |
| Group 2 | Placebo | This reporting group includes all the patients who has received placebo of aliskiren plus placebo of an additional BP lowering drug (amlodipine or hydrochlorothiazide). This reporting group includes patients from arms such as Placebo for Aliskiren + Placebo for HCTZ and Placebo for aliskiren + Placebo for Amlodipine . | 8 | 452 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Composite Cardiovascular Endpoints in Aliskiren+Amlodipine/HCTZ Group Versus All Placebo Group
- 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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