Trial · NCT00739973
Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension
NCT00739973, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-05-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension. Trials, record NCT00739973. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00739973
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension
- NCT number
- NCT00739973
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,694 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Hypertension
- Interventions
Placebo, Aliskiren 150 mg tablet, Aliskiren 300 mg tablet, Amlodipine 5 mg capsule, Amlodipine 10 mg capsule, Aliskiren/amlodipine 150/5 mg tablet, Aliskiren/amlodipine 150/10 mg tablet, Aliskiren/amlodipine 300/5 mg tablet, Aliskiren/amlodipine 300/10 mg tablet
- First posted
- 2008-08-22
- Last updated
- 2011-06-06
- Results first posted
- 2011-05-03
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Primary | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Primary | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Primary | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Primary | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Primary | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Primary | Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Primary | Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Primary | Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
| Primary | Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Baseline to end of study (Week 8) | Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug. | mm Hg | LEAST_SQUARES_MEAN |
| SECONDARY | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Baseline to end of study (Week 8) | Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug. | mm Hg | LEAST_SQUARES_MEAN |
| SECONDARY | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Baseline to end of study (Week 8) | Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug. | mm Hg | LEAST_SQUARES_MEAN |
| SECONDARY | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP) | Baseline to end of study (Week 8) | Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug. | mm Hg | LEAST_SQUARES_MEAN |
| PRIMARY | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug. | mm Hg | LEAST_SQUARES_MEAN |
| PRIMARY | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug. | mm Hg | LEAST_SQUARES_MEAN |
| PRIMARY | Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug. | mm Hg | LEAST_SQUARES_MEAN |
| PRIMARY | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug. | mm Hg | LEAST_SQUARES_MEAN |
| PRIMARY | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug. | mm Hg | LEAST_SQUARES_MEAN |
| PRIMARY | Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline to end of study (Week 8) | Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug. | mm Hg | LEAST_SQUARES_MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group75
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Aliskiren 150 mg | -10.67 | Standard Error 1.01 | mm Hg | |
| Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Aliskiren/Amlodipine 150/5 mg | -20.64 | Standard Error 1.05 | mm Hg | |
| Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Amlodipine 5 mg | -15.82 | Standard Error 1.04 | mm Hg | |
| Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Aliskiren/Amlodipine 150/5 mg | -20.64 | Standard Error 1.05 | mm Hg | |
| Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Placebo | -6.79 | Standard Error 1.00 | mm Hg | |
| Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP) | Aliskiren/Amlodipine 150/5 mg | -20.64 | Standard Error 1.05 | mm Hg | |
| Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP) | Aliskiren 150 mg | -10.67 | Standard Error 1.01 | mm Hg | |
| Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP) | Aliskiren/Amlodipine 150/10 mg | -23.87 | Standard Error 1.05 | mm Hg | |
| Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Aliskiren 150 mg | -7.99 | Standard Error 0.63 | mm Hg | |
| Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) | Aliskiren/Amlodipine 150/5 mg | -13.98 | Standard Error 0.66 | mm Hg |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Single-blind Period (2 to 4 Weeks) | STARTED | Placebo | 2,694 | |
| Single-blind Period (2 to 4 Weeks) | STARTED | Aliskiren 150 mg | 0 | |
| Single-blind Period (2 to 4 Weeks) | STARTED | Aliskiren 300 mg | 0 | |
| Single-blind Period (2 to 4 Weeks) | STARTED | Amlodipine 5 mg | 0 | |
| Single-blind Period (2 to 4 Weeks) | STARTED | Amlodipine 10 mg | 0 | |
| Single-blind Period (2 to 4 Weeks) | STARTED | Aliskiren/Amlodipine 150/5 mg | 0 | |
| Single-blind Period (2 to 4 Weeks) | STARTED | Aliskiren/Amlodipine 150/10 mg | 0 | |
| Single-blind Period (2 to 4 Weeks) | STARTED | Aliskiren/Amlodipine 300/5 mg | 0 | |
| Single-blind Period (2 to 4 Weeks) | STARTED | Aliskiren/Amlodipine 300/10 mg Tablet | 0 | |
| Single-blind Period (2 to 4 Weeks) | COMPLETED | Placebo | 1,685 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events99
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 | Placebo | 2 | 198 | |
| other | Oedema peripheral | General disorders | Aliskiren 150 mg Tablet | 2 | 194 | |
| other | Oedema peripheral | General disorders | Aliskiren 300 mg Tablet | 3 | 203 | |
| other | Oedema peripheral | General disorders | Amlodipine 5 mg Capsule | 8 | 185 | |
| other | Oedema peripheral | General disorders | Amlodipine 10 mg Capsule | 25 | 181 | |
| other | Oedema peripheral | General disorders | Aliskiren/Amlodipine 150/5 mg Tablet | 4 | 181 | |
| other | Oedema peripheral | General disorders | Aliskiren/Amlodipine 150/10 mg Tablet | 14 | 181 | |
| other | Oedema peripheral | General disorders | Aliskiren/Amlodipine 300/5 mg Tablet | 2 | 178 | |
| other | Oedema peripheral | General disorders | Aliskiren/Amlodipine 300/10 mg Tablet | 25 | 184 | |
| other | Headache | Nervous system disorders | Placebo | 20 | 198 |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Aliskiren 150 mg Tablet | ||
| Total, all-cause mortality | Aliskiren 300 mg Tablet | ||
| Total, all-cause mortality | Amlodipine 5 mg Capsule | ||
| Total, all-cause mortality | Amlodipine 10 mg Capsule | ||
| Total, all-cause mortality | Aliskiren/Amlodipine 150/5 mg Tablet | ||
| Total, all-cause mortality | Aliskiren/Amlodipine 150/10 mg Tablet | ||
| Total, all-cause mortality | Aliskiren/Amlodipine 300/5 mg Tablet | ||
| Total, all-cause mortality | Aliskiren/Amlodipine 300/10 mg Tablet | ||
| Total, other adverse events | Placebo | 22 | 198 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 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/NCT00739973
GET https://conductscience.org/api/trials/v1/NCT00739973/registered?page=2