Trial · NCT01259297
A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People
NCT01259297, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2014-04-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People. Trials, record NCT01259297. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01259297
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People
- NCT number
- NCT01259297
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 2,336 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Cardiovascular Events
- Interventions
- Aliskiren, Amlodipine, Hydrochlorothiazide (HCTZ), Placebo for Aliskiren, Placebo for Amlodipine, Placebo for Hydrochlorothiazide (HCTZ)
- First posted
- 2010-12-14
- Last updated
- 2014-04-08
- Other registries' IDs
- eudract:2009-010170-38
- Results first posted
- 2014-04-08
- Limitations and caveats
Due to early termination, 1759 patients were randomized as against 11,000. Only 25 primary endpoints had accrued during median follow-up of 209 days as against planned 2000 in 5 years. These low numbers significantly limit interpretation of results.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Composite Cardiovascular Endpoints in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen | End of study (209 days (median)) | The composite CV endpoint is based on the following first adjudicated events: CV death, non-fatal MI,non-fatal stroke, significant heart failure |
| Primary | Number of Participants With Composite Cardiovascular Endpoints in Aliskiren+Amlodipine/HCTZ Group Versus All Placebo Group | End of study (209 days (median)) | The composite CV endpoint is based on the following first adjudicated events: CV death, non-fatal MI,non-fatal stroke, significant heart failure |
| Secondary | Change From Baseline to End of Study in Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part I) | Baseline, End of study (209 days [median]) | Decline in ability to perform everyday activities independently was measured primarily by using the Standard Assessment of Global Activities in the Elderly (SAGE) scale. The SAGE comprised of 15 questions, each describing an activity. Patient had to indicate how much difficulty he/she had encountered in performing the activity in last month. Each question's score ranges from 0 (No difficulty) to 3 (difficulty levels were mild (score = 1), moderate (score =2) and severe (score=3)). Part I of SAGE included 4 dimensions: * Community Cognition (maximum of scores of questions 1 to 6); * Instrumental Activities of daily Living (IADL) (maximum of scores of questions 7 to 10); * Mobility (maximum of scores of questions 11 and 12);. * Basic Activities of daily Living (ADL) (maximum of scores of questions 13 to 15) Each dimension's total score ranged from 0 to 3. 0=best, 3=worst A negative change in value from baseline means improvement in the ability to perform everyday activities. |
| Secondary | Percentage of Participants With Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part II) | End of study (209 days [median]) | Decline in ability to perform everyday activities independently was measured primarily by using the Standard Assessment of Global Activities in the Elderly (SAGE) scale. The SAGE was comprised of 15 questions, each describing an activity. Patient had to indicate how much difficulty he/she had encountered in performing the activity in the last month. Each question's score ranges from 0 (No difficulty) to 3 (difficulty levels were mild (score = 1), moderate (score =2) and severe (score=3)). Part II of SAGE included 2 dimensions: * "Normal" if the scores of all SAGE questions is 0 (i.e., No difficulty) * "Mobility Only" if scores of both SAGE questions 11 and 12 are 0 |
| Secondary | Number of Participants With Renal Dysfunction in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen | End of study (209 days (median)) | The renal dysfunction (composite endpoint) was defined as the first occurrence of either of the following: * End-stage renal disease \[ESRD\] requiring dialysis or transplantation * Doubling of serum creatinine and reaching an eGFR \< 45 ml/min/1.73 m\^2. |
| Secondary | Number of Participants With Total Mortality in Aliskiren Based Regimen Versus Non-aliskiren Based Regimen | End of study (209 days (median)) | The total mortality endpoint was defined as time to death from any cause. Total mortality analysis used the date of last follow-up including the washout period as the censoring date. |
| Other | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | Baseline (BL), 6 week, 6 month and 12 month | Mean sitting systolic blood pressure (msSBP) is the average of 2 sitting SBP measurements (2 minutes apart). Since each patient had their final follow-up visit at a different time in the trial, these measurements were classified as falling into the 6 week, 6 month, or 12 month measurement period. All available blood pressures were sorted within these periods and the last value within each time range used for analysis. At each timepoint, a patient must have both baseline and postbaseline values to be included in the analysis. |
| Other | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline (BL), 6 week, 6 month and 12 month | Mean sitting diastolic blood pressure (msDBP) is the average of 2 sitting DBP measurements (2 minutes apart). Since each patient had their final follow-up visit at a different time in the trial, these measurements were classified as falling into the 6 week, 6 month, or 12 month measurement period. All available blood pressures were sorted within these periods and the last value within each time range used for analysis. At each timepoint, a patient must have both baseline and postbaseline values to be included in the analysis. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Composite Cardiovascular Endpoints in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen | End of study (209 days (median)) | 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. | participants | NUMBER |
| SECONDARY | Change From Baseline to End of Study in Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part I) | Baseline, End of study (209 days [median]) | Full Analysis Set: Due to the sparse post-baseline data following early termination of the study, this analysis was not performed as planned in protocol.Hence, no meaningful conclusion could be drawn. Patients who completed both baseline and post-baseline SAGE questionnaires (Part II) were included in this analysis. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | Baseline (BL), 6 week, 6 month and 12 month | Full analysis Set : All randomized patients, regardless of receiving study medication. n=number of patients with non-missing assessments at baseline and each post-baseline visit. | mmHg | LEAST_SQUARES_MEAN |
| PRIMARY | Number of Participants With Composite Cardiovascular Endpoints in Aliskiren+Amlodipine/HCTZ Group Versus All Placebo Group | End of study (209 days (median)) | 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. | participants | NUMBER |
| SECONDARY | Percentage of Participants With Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part II) | End of study (209 days [median]) | Full Analysis Set. Number of patients with all SAGE questions non-missing for the specific visit are included in this population. Due to the sparse post-baseline data following early termination of the study, this analysis was not performed as planned in protocol.Hence, no meaningful conclusion could be drawn. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Renal Dysfunction in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen | End of study (209 days (median)) | Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. The duration of study follow-up was 209 days (median) as against the planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline (BL), 6 week, 6 month and 12 month | Full analysis Set : All randomized patients, regardless of receiving study medication. n=number of patients with non-missing assessments at baseline and each post-baseline visit. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Total Mortality in Aliskiren Based Regimen Versus Non-aliskiren Based Regimen | End of study (209 days (median)) | Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. The duration of study follow-up was 209 days (median) as against the planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Composite Cardiovascular Endpoints in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen | Aliskiren Based Regimen | 11 | participants | ||
| Number of Participants With Composite Cardiovascular Endpoints in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen | Non-Aliskiren Based Regimen | 14 | participants | ||
| Change From Baseline to End of Study in Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part I) | Aliskiren Based Regimen | Community Cognition | -0.04 | Standard Deviation 0.768 | units on a scale |
| Change From Baseline to End of Study in Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part I) | Non-Aliskiren Based Regimen | Community Cognition | -0.05 | Standard Deviation 0.741 | units on a scale |
| Change From Baseline to End of Study in Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part I) | Aliskiren Based Regimen | Instrumental Activities of daily Living (IADL) | -0.06 | Standard Deviation 0.562 | units on a scale |
| Change From Baseline to End of Study in Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part I) | Non-Aliskiren Based Regimen | Instrumental Activities of daily Living (IADL) | -0.04 | Standard Deviation 0.505 | units on a scale |
| Change From Baseline to End of Study in Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part I) | Aliskiren Based Regimen | Mobility | 0.01 | Standard Deviation 0.791 | units on a scale |
| Change From Baseline to End of Study in Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part I) | Non-Aliskiren Based Regimen | Mobility | 0.00 | Standard Deviation 0.779 | units on a scale |
| Change From Baseline to End of Study in Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part I) | Aliskiren Based Regimen | ADL | -0.09 | Standard Deviation 0.525 | units on a scale |
| Change From Baseline to End of Study in Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part I) | Non-Aliskiren Based Regimen | ADL | -0.08 | Standard Deviation 0.520 | units on a scale |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-in Open Label Period (4-5 Weeks) | STARTED | Aliskiren + Hydrochlorothiazide (HCTZ) | 1,335 | |
| Run-in Open Label Period (4-5 Weeks) | STARTED | Aliskiren + Placebo for HCTZ | 0 | |
| Run-in Open Label Period (4-5 Weeks) | STARTED | Aliskiren + Amlodipine | 1,001 | |
| Run-in Open Label Period (4-5 Weeks) | STARTED | Aliskiren + Placebo for Amlodipine | 0 | |
| Run-in Open Label Period (4-5 Weeks) | STARTED | HCTZ + Placebo for Aliskiren | 0 | |
| Run-in Open Label Period (4-5 Weeks) | STARTED | Placebo for Aliskiren + Placebo for HCTZ | 0 | |
| Run-in Open Label Period (4-5 Weeks) | STARTED | Amlodipine + Placebo for Aliskiren | 0 | |
| Run-in Open Label Period (4-5 Weeks) | STARTED | Placebo for Aliskiren + Placebo for Amlodipine | 0 | |
| Run-in Open Label Period (4-5 Weeks) | COMPLETED | Aliskiren + Hydrochlorothiazide (HCTZ) | 980 | |
| Run-in Open Label Period (4-5 Weeks) | COMPLETED | Aliskiren + Placebo for HCTZ | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events590
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastritis | Gastrointestinal disorders | Run-in Period: Aliskiren + Hydrochlorothiazide (HCTZ) | 0 | 1,335 | |
| other | Gastritis | Gastrointestinal disorders | Run-in Period: Aliskiren + Amlodipine | 0 | 1,001 | |
| other | Gastritis | Gastrointestinal disorders | Double Blind Period: Aliskiren + Hydrochlorothiazide (HCTZ) | 0 | 244 | |
| other | Gastritis | Gastrointestinal disorders | Double Blind Period: Aliskiren + Placebo for HCTZ | 0 | 232 | |
| other | Gastritis | Gastrointestinal disorders | Double Blind Period: Aliskiren + Amlodipine | 0 | 189 | |
| other | Gastritis | Gastrointestinal disorders | Double Blind Period: Aliskiren + Placebo for Amlodipine | 2 | 195 | |
| other | Gastritis | Gastrointestinal disorders | Double Blind Period: HCTZ + Placebo for Aliskiren | 0 | 251 | |
| other | Gastritis | Gastrointestinal disorders | Double Blind Period: Placebo for Aliskiren + Placebo for HCTZ | 0 | 253 | |
| other | Gastritis | Gastrointestinal disorders | Double Blind Period: Amlodipine + Placebo for Aliskiren | 1 | 196 | |
| other | Gastritis | Gastrointestinal disorders | Double Blind Period: Placebo for Aliskiren + Placebo for Amlod | 1 | 199 |
1 to 10 of 590Source ClinicalTrials.gov
See all 590 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Run-in Period: Aliskiren + Hydrochlorothiazide (HCTZ) | ||
| Total, all-cause mortality | Run-in Period: Aliskiren + Amlodipine | ||
| Total, all-cause mortality | Double Blind Period: Aliskiren + Hydrochlorothiazide (HCTZ) | ||
| Total, all-cause mortality | Double Blind Period: Aliskiren + Placebo for HCTZ | ||
| Total, all-cause mortality | Double Blind Period: Aliskiren + Amlodipine | ||
| Total, all-cause mortality | Double Blind Period: Aliskiren + Placebo for Amlodipine | ||
| Total, all-cause mortality | Double Blind Period: HCTZ + Placebo for Aliskiren | ||
| Total, all-cause mortality | Double Blind Period: Placebo for Aliskiren + Placebo for HCTZ | ||
| Total, all-cause mortality | Double Blind Period: Amlodipine + Placebo for Aliskiren | ||
| Total, all-cause mortality | Double Blind Period: Placebo for Aliskiren + Placebo for Amlod |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24616335 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Aliskiren+Amlodipine/HCTZ Group vs Placebo: Number of Participants With Composite Cardiovascular Endpoints in Aliskiren+Amlodipine/HCTZ Group Versus All Placebo Group | Trial comparisons |
| 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 |
| Aliskiren Based Regimen vs Non-Aliskiren Based Regimen: Number of Participants With Total Mortality in Aliskiren Based Regimen Versus Non-aliskiren Based Regimen | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01259297
GET https://conductscience.org/api/trials/v1/NCT01259297/results?page=2