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This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Aliskiren 75 mg | Experimental |
| |
| Aliskiren 150 mg | Experimental |
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| Aliskiren 300 mg | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo tablet taken once daily in the morning with a light meal. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8) | Baseline to end of study (Week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Baseline to end of study (Week 8) | |
| Percentage of Patients Achieving Systolic Blood Pressure Response | Patients achieving a systolic blood pressure response had to have a msSBP < 140 mmHg at the end of the study and/or a ≥ 20 mmHg reduction in msSBP from baseline to the end of the study. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria applied to the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Buenos Aires | Argentina | ||||
| Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo tablet taken once daily in the morning with a light meal. |
| FG001 | Aliskiren 75 mg | Aliskiren 75 mg tablet taken once daily in the morning with a light meal. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Aliskiren 75 mg |
| Drug |
Aliskiren 75 mg tablet taken once daily in the morning with a light meal. |
|
| Aliskiren 150 mg | Drug | Aliskiren 150 mg tablet taken once daily in the morning with a light meal. |
|
| Aliskiren 300 mg | Drug | Aliskiren 300 mg tablet taken once daily in the morning with a light meal. |
|
| Baseline to end of study (Week 8) |
| Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study | Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient. | Baseline to end of study (Week 8) |
| Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8) | Smoothness index (SI) is a measure of consistency of the BP reduction over 24 hours. The SI was obtained by first calculating the mean blood pressure value at each hour of the 24-hour ambulatory blood pressure monitoring period, both before and during treatment. Similarly, the change from baseline in blood pressure was calculated at each hour. The average hourly change from baseline (δh) and standard deviation (std δh) of the hourly changes were computed, and the SI was derived: SI = δh/std δh. A negative change score indicates improvement. | Baseline to end of study (Week 8) |
| Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8) | The morning surge was defined as the average of the hourly means in the last three hours (hours 22, 23, 24) of the 24 hour ambulatory blood pressure monitoring assessment period. | Baseline to end of study (week 8) |
| Prague |
| Czechia |
| Investigative Site | Berlin | Germany |
| Investigative Site | Reykjavik | Iceland |
| Investigative Site | Rome | Italy |
| Investigative Site | Amsterdam | Netherlands |
| Investigative Site | Warsaw | Poland |
| Investigative Site | Bratislava | Slovakia |
| FG002 | Aliskiren 150 mg | Aliskiren 150 mg tablet taken once daily in the morning with a light meal. |
| FG003 | Aliskiren 300 mg | Aliskiren 300 mg tablet taken once daily in the morning with a light meal. |
| Entered Double-blind Period |
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| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo tablet taken once daily in the morning with a light meal. |
| BG001 | Aliskiren 75 mg | Aliskiren 75 mg tablet taken once daily in the morning with a light meal. |
| BG002 | Aliskiren 150 mg | Aliskiren 150 mg tablet taken once daily in the morning with a light meal. |
| BG003 | Aliskiren 300 mg | Aliskiren 300 mg tablet taken once daily in the morning with a light meal. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8) | Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline to end of study (Week 8) |
|
|
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| Secondary | Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline to end of study (Week 8) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving Systolic Blood Pressure Response | Patients achieving a systolic blood pressure response had to have a msSBP < 140 mmHg at the end of the study and/or a ≥ 20 mmHg reduction in msSBP from baseline to the end of the study. | Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS. | Posted | Number | Percentage of participants | Baseline to end of study (Week 8) |
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| Secondary | Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study | Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient. | Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully. | Posted | Mean | Standard Error | mmHg | Baseline to end of study (Week 8) |
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| Secondary | Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8) | Smoothness index (SI) is a measure of consistency of the BP reduction over 24 hours. The SI was obtained by first calculating the mean blood pressure value at each hour of the 24-hour ambulatory blood pressure monitoring period, both before and during treatment. Similarly, the change from baseline in blood pressure was calculated at each hour. The average hourly change from baseline (δh) and standard deviation (std δh) of the hourly changes were computed, and the SI was derived: SI = δh/std δh. A negative change score indicates improvement. | Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully. | Posted | Least Squares Mean | Standard Error | Ratio | Baseline to end of study (Week 8) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8) | The morning surge was defined as the average of the hourly means in the last three hours (hours 22, 23, 24) of the 24 hour ambulatory blood pressure monitoring assessment period. | Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline to end of study (week 8) |
|
End of study (week 8)
Population description of safety set.
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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 | Placebo | Placebo tablet taken once daily in the morning with a light meal. | 1 | 186 | 0 | 186 | ||
| EG001 | Aliskiren 75 mg | Aliskiren 75 mg tablet taken once daily in the morning with a light meal. | 2 | 191 | 0 | 191 | ||
| EG002 | Aliskiren 150 mg | Aliskiren 150 mg tablet taken once daily in the morning with a light meal. | 3 | 189 | 0 | 189 | ||
| EG003 | Aliskiren 300 mg | Aliskiren 300 mg tablet taken once daily in the morning with a light meal. | 0 | 188 | 0 | 188 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Wrist fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Haemorrhagic stroke | 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 |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
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| ≥ 75 years of age |
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| Male |
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| Participants |
|
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| Units | Counts |
|---|---|
| Participants |
|
|
|
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| OG003 | Aliskiren 300 mg | Aliskiren 300 mg tablet taken once daily in the morning with a light meal. |
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