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This study will compare the safety and efficacy of once daily dosing of aliskiren to twice daily dosing of aliskiren in patients with moderate hypertension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aliskiren 300 mg (Once a Day) | Experimental | Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks. |
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| Aliskiren 150 mg (Twice a Day) | Experimental | Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug | Aliskiren supplied in 150 mg and 300 mg tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) | An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MADBP from baseline to the 24 hour MADBP at 6 weeks was calculated using an Analysis of covariance (ANCOVA) model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate. | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 6 in the Mean Ambulatory Diastolic Blood Pressure (MADBP) During the Last 3 Hours of the 24-hour Dosing Period | An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 22-24 hour period were calculated. The difference from the last 3 hours MADBP at baseline to the last 3 hour MADBP at Week 6 was calculated using an ANCOVA model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Zanesville | Ohio | United States | |||
| Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aliskiren 300 mg (Once a Day) | Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks. |
| FG001 | Aliskiren 150 mg (Twice a Day) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo to Aliskiren | Drug | Placebo to Aliskiren matching 150 and 300 mg tablets |
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| Baseline, Week 6 |
| Change From Baseline to Week 6 in the Mean Ambulatory Systolic Blood Pressure (MASBP) During the Last Three Hours of the 24-hour Dosing Period | An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 22-24 hour period were calculated. The difference from the last 3 hours MASBP at baseline to the last 3 hour MASBP at Week 6 was calculated using an ANCOVA model with baseline mean 24 hour ambulatory systolic blood pressure as a covariate. | Baseline, Week 6 |
| Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) | An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MASBP from baseline to the 24 hour MASBP at 6 weeks was calculated using an ANCOVA model with baseline mean 24 hour ambulatory systolic blood pressure as a covariate. | Baseline, Week 6 |
| Change From Baseline to Week 6 in the Mean Sitting Systolic and Mean Sitting Diastolic Blood Pressure | After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure. The ANCOVA model used baseline as a covariate. | Baseline, Week 6 |
| Percentage of Participants Achieving Blood Pressure Control at Week 6 | After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer. The mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure at visit 3 (week 6). Blood pressure control was defined as having a mean sitting diastolic blood pressure (msDBP) <90 mm Hg and a mean sitting systolic blood pressure (msSBP) <140 mm Hg. | Week 6 |
| Percentage of Participants Achieving Blood Pressure Control at the End of the Study (Week 10) | After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer. The mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure at visit 4 (week 10). Blood pressure control was defined as having a mean sitting diastolic blood pressure (msDBP) <90 mm Hg and a mean sitting systolic blood pressure (msSBP) <140 mm Hg. | Week 10 |
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| Germany |
| Investigative Site | Valencia | Spain |
Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aliskiren 300 mg (Once a Day) | Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks. |
| BG001 | Aliskiren 150 mg (Twice a Day) | Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) | An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MADBP from baseline to the 24 hour MADBP at 6 weeks was calculated using an Analysis of covariance (ANCOVA) model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate. | Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline, Week 6 |
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| Secondary | Change From Baseline to Week 6 in the Mean Ambulatory Diastolic Blood Pressure (MADBP) During the Last 3 Hours of the 24-hour Dosing Period | An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 22-24 hour period were calculated. The difference from the last 3 hours MADBP at baseline to the last 3 hour MADBP at Week 6 was calculated using an ANCOVA model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate. | Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline, Week 6 |
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| Secondary | Change From Baseline to Week 6 in the Mean Ambulatory Systolic Blood Pressure (MASBP) During the Last Three Hours of the 24-hour Dosing Period | An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 22-24 hour period were calculated. The difference from the last 3 hours MASBP at baseline to the last 3 hour MASBP at Week 6 was calculated using an ANCOVA model with baseline mean 24 hour ambulatory systolic blood pressure as a covariate. | Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline, Week 6 |
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| Secondary | Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) | An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MASBP from baseline to the 24 hour MASBP at 6 weeks was calculated using an ANCOVA model with baseline mean 24 hour ambulatory systolic blood pressure as a covariate. | Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline, Week 6 |
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| Secondary | Change From Baseline to Week 6 in the Mean Sitting Systolic and Mean Sitting Diastolic Blood Pressure | After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure. The ANCOVA model used baseline as a covariate. | Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline, Week 6 |
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| Secondary | Percentage of Participants Achieving Blood Pressure Control at Week 6 | After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer. The mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure at visit 3 (week 6). Blood pressure control was defined as having a mean sitting diastolic blood pressure (msDBP) <90 mm Hg and a mean sitting systolic blood pressure (msSBP) <140 mm Hg. | Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Week 6. | Posted | Number | Percentage of participants | Week 6 |
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| Secondary | Percentage of Participants Achieving Blood Pressure Control at the End of the Study (Week 10) | After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer. The mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure at visit 4 (week 10). Blood pressure control was defined as having a mean sitting diastolic blood pressure (msDBP) <90 mm Hg and a mean sitting systolic blood pressure (msSBP) <140 mm Hg. | Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Week 10. | Posted | Number | Percentage of participants | Week 10 |
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10 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aliskiren 300 mg (Once a Day) | Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks. | 2 | 164 | 0 | 164 | ||
| EG001 | Aliskiren 150 mg (Twice a Day) | Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening. | 2 | 164 | 0 | 164 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
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