Trial · NCT00765674
Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension
NCT00765674, Phase 3, Completed, Novartis; results first posted 2011-05-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension. Trials, record NCT00765674. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00765674
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension
- NCT number
- NCT00765674
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,191 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Hypertension
- Interventions
- Aliskiren, Amlodipine, Hydrochlorothiazide (HCTZ), Placebo, Placebo
- First posted
- 2008-10-03
- Last updated
- 2011-05-09
- Results first posted
- 2011-05-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Baseline to end of study (Week 8) | Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was \< 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP. |
| Secondary | Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Baseline to end of study (Week 8) | Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was \< 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP. |
| Secondary | Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8) | End of study (Week 8) | Blood pressure control was defined as a msSBP/msDBP \< 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. |
| Secondary | Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8) | Baseline to end of study (Week 8) | Twenty-four hour ambulatory blood pressure monitoring (ABPM) was performed in a subset of patients twice during the study, once at baseline and again at Week 8. The ABPM device was placed on the non-dominant arm between 7:00 and 10:00 am and verification readings obtained. If they were successful, the investigator initiated the 24 hour reading and instructed the patient regarding ABPM procedures. On the next day, the ABPM device was removed if it had been worn for a minimum of 24 hours. The ABPM data were downloaded and evaluated on site. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Baseline to end of study (Week 8) | Full analysis set population: All randomized patients who had post-baseline efficacy measurements. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Baseline to end of study (Week 8) | Full analysis set population: All randomized patients who had post-baseline efficacy measurements. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8) | End of study (Week 8) | Full analysis set population: All randomized patients who had post-baseline efficacy measurements. | Percentage of patients | NUMBER |
| SECONDARY | Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8) | Baseline to end of study (Week 8) | Full analysis set population: All randomized patients who had post-baseline efficacy measurements. | mmHg | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Aliskiren / Amlodipine | -31.37 | Standard Error 0.90 | mmHg | |
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Aliskiren / Hydrochlorothiazide | -27.99 | Standard Error 0.88 | mmHg | |
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Amlodipine / Hydrochlorothiazide | -30.77 | Standard Error 0.88 | mmHg | |
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Aliskiren / Amlodipine / Hydrochlorothiazide | -37.92 | Standard Error 0.86 | mmHg | |
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Aliskiren / Amlodipine | -18.03 | Standard Error 0.57 | mmHg | |
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Aliskiren / Hydrochlorothiazide | -14.32 | Standard Error 0.55 | mmHg | |
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Amlodipine / Hydrochlorothiazide | -17.03 | Standard Error 0.55 | mmHg | |
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Aliskiren / Amlodipine / Hydrochlorothiazide | -20.63 | Standard Error 0.54 | mmHg | |
| Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8) | Aliskiren / Amlodipine | 41.3 | Percentage of patients | ||
| Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8) | Aliskiren / Hydrochlorothiazide | 33.1 | Percentage of patients |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aliskiren / Amlodipine | 287 | |
| Overall Study | STARTED | Aliskiren / Hydrochlorothiazide | 298 | |
| Overall Study | STARTED | Amlodipine / Hydrochlorothiazide | 296 | |
| Overall Study | STARTED | Aliskiren / Amlodipine / Hydrochlorothiazide | 310 | |
| Overall Study | COMPLETED | Aliskiren / Amlodipine | 266 | |
| Overall Study | COMPLETED | Aliskiren / Hydrochlorothiazide | 276 | |
| Overall Study | COMPLETED | Amlodipine / Hydrochlorothiazide | 279 | |
| Overall Study | COMPLETED | Aliskiren / Amlodipine / Hydrochlorothiazide | 285 | |
| Overall Study | NOT COMPLETED | Aliskiren / Amlodipine | 21 | |
| Overall Study | NOT COMPLETED | Aliskiren / Hydrochlorothiazide | 22 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events60
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 | Oedema peripheral | General disorders | Aliskiren / Amlodipine | 23 | 287 | |
| other | Oedema peripheral | General disorders | Aliskiren / Hydrochlorothiazide | 6 | 297 | |
| other | Oedema peripheral | General disorders | Amlodipine / Hydrochlorothiazide | 12 | 295 | |
| other | Oedema peripheral | General disorders | Aliskiren / Amlodipine / Hydrochlorothiazide | 22 | 309 | |
| other | Headache | Nervous system disorders | Aliskiren / Amlodipine | 9 | 287 | |
| other | Headache | Nervous system disorders | Aliskiren / Hydrochlorothiazide | 12 | 297 | |
| other | Headache | Nervous system disorders | Amlodipine / Hydrochlorothiazide | 15 | 295 | |
| other | Headache | Nervous system disorders | Aliskiren / Amlodipine / Hydrochlorothiazide | 11 | 309 | |
| serious | Acute coronary syndrome | Cardiac disorders | Aliskiren / Amlodipine | 0 | 287 | |
| serious | Acute coronary syndrome | Cardiac disorders | Aliskiren / Hydrochlorothiazide | 0 | 297 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aliskiren / Amlodipine | ||
| Total, all-cause mortality | Aliskiren / Hydrochlorothiazide | ||
| Total, all-cause mortality | Amlodipine / Hydrochlorothiazide | ||
| Total, all-cause mortality | Aliskiren / Amlodipine / Hydrochlorothiazide | ||
| Total, other adverse events | Aliskiren / Amlodipine | 32 | 287 |
| Total, other adverse events | Aliskiren / Hydrochlorothiazide | 17 | 297 |
| Total, other adverse events | Amlodipine / Hydrochlorothiazide | 26 | 295 |
| Total, other adverse events | Aliskiren / Amlodipine / Hydrochlorothiazide | 29 | 309 |
| Total, serious adverse events | Aliskiren / Amlodipine | 3 | 287 |
| Total, serious adverse events | Aliskiren / Hydrochlorothiazide | 2 | 297 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00765674
GET https://conductscience.org/api/trials/v1/NCT00765674/events?page=2