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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005297-36 | EudraCT Number |
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The purpose of this study is to evaluate the effect of food on aliskiren's efficacy, pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light meal versus fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aliskiren: Fed | Experimental | Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast |
|
| Aliskiren: Fasting | Experimental | Aliskiren 300 mg once daily taken after after an overnight fast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug | Aliskiren 300 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP) | 24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maSBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate. | Baseline, week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP) | 24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maDBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
-
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Los Angeles | California | 90057 | United States | ||
| Novartis Investigative Site |
A total of 691 patients enrolled in the study with 590 patients randomized. 1 patient was mis-randomized and did not receive study medication, therefore 589 patients actually received study medication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aliskiren: Fed | Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast |
| FG001 | Aliskiren: Fasting | Aliskiren 300 mg once daily taken after after an overnight fast |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline, week 8 |
| Percentage of Patients Achieving Blood Pressure Control | Patients achieving blood pressure control were patients who, at week 8, had a mean sitting systolic blood pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) < 140/90 mmHg | 8 weeks |
| Change From Baseline (Visit 3) to End of Study (8 Weeks) in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | Sitting blood pressure (BP) was measured at trough (approximately 24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the BP was checked in both arms and the arm with higher systolic BP (SBP) was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures (msSBP and msDBP) were measured four times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 2 minute intervals and the mean of all four sitting blood pressure measurements was used as the average sitting office blood pressure for that visit. The analysis of covariance (ANCOVA) model used treatment, region as factors, and baseline as covariate. | Baseline, Week 8 |
| Percentage of Patients Achieving a Successful Response in Systolic Blood Pressure Reduction | Successful response in systolic blood pressure reduction at end of 8-week treatment was defined as msSBP <140 mmHg or a reduction in msSBP ≥ 20 mmHg from baseline. | Baseline, Week 8 |
| Pharmacokinetic (PK) of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration in Fasted vs. Fed | Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis. | Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) |
| Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) in Fasted vs. Fed | Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis. | Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) |
| Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration in Fasted vs. Fed | Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis. | Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) |
| Change From Baseline to Week 8 in Plasma Renin Activity (PRA) | Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin activity (PRA) . Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8).The difference between baseline and week 8 was calculated. | Baseline, Week 8 |
| Change From Baseline to Week 8 in Plasma Renin Concentration (PRC) | Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin concentration (PRC). Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8). The difference between baseline and week 8 was calculated. | Baseline, Week 8 |
| Number of Patients With Adverse Events, Serious Adverse Events and Death | 8 weeks |
| Riverside |
| California |
| 92506 |
| United States |
| Novartis Investigative Site | Santa Monica | California | 90404 | United States |
| Novartis Investigative Site | Walnut Creek | California | 94598 | United States |
| Novartis Investigative Site | Westlake Village | California | 91361 | United States |
| Novartis Investigative Site | Coral Gables | Florida | 33134 | United States |
| Novartis Investigative Site | Miami | Florida | 33169 | United States |
| Novartis Investigative Site | South Miami | Florida | 33143 | United States |
| Novartis Investigative Site | Chicago | Illinois | 60607 | United States |
| Novartis Investigative Site | Chicago | Illinois | 60610 | United States |
| Novartis Investigative Site | Evansville | Indiana | 47712 | United States |
| Novartis Investigative Site | Topeka | Kansas | 66606 | United States |
| Novartis Investigative Site | Opelousas | Louisiana | 70570 | United States |
| Novartis Investigative Site | Chaska | Minnesota | 55318 | United States |
| Novartis Investigative Site | Edina | Minnesota | 55435 | United States |
| Novartis Investigative Site | Saint Paul | Minnesota | 55114 | United States |
| Novartis Investigative Site | Jackson | Mississippi | 39209 | United States |
| Novartis Investigative Site | Picayune | Mississippi | 39466 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63141 | United States |
| Novartis Investigative Site | Charlotte | North Carolina | 28209 | United States |
| Novartis Investigative Site | Greensboro | North Carolina | 27401 | United States |
| Novartis Investigative Site | Greensboro | North Carolina | 27408 | United States |
| Novartis Investigative Site | Salisbury | North Carolina | 28144 | United States |
| Novartis Investigative Site | Shelby | North Carolina | 28152 | United States |
| Novartis Investigative Site | Winston-Salem | North Carolina | 27103 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45246 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43213 | United States |
| Novartis Investigative Site | Lyndhurst | Ohio | 44124 | United States |
| Novartis Investigative Site | Marion | Ohio | 43302 | United States |
| Novartis Investigative Site | Norman | Oklahoma | 73069 | United States |
| Novartis Investigative Site | Eugene | Oregon | 97404 | United States |
| Novartis Investigative Site | Oregon City | Oregon | 97045 | United States |
| Novartis Investigative Site | Portland | Oregon | 97239 | United States |
| Novartis Investigative Site | Knoxville | Tennessee | 37920 | United States |
| Novartis Investigative Site | Beaumont | Texas | 77702 | United States |
| Novartis Investigative Site | Houston | Texas | 77081 | United States |
| Novartis Investigative Site | Lake Jackson | Texas | 77566 | United States |
| Novartis Investigative Site | Pasadena | Texas | 77504 | United States |
| Novartis Investigative Site | Centerville | Utah | 84104 | United States |
| Novartis Investigative Site | Arlington | Virginia | 22203 | United States |
| Novartis Investigative Site | Ettrick | Virginia | 23803 | United States |
| Novartis Investigative Site | Midlothian | Virginia | 23114 | United States |
| Novartis Investigative Site | Port Orchard | Washington | 98366 | United States |
| Novartis Investigative Site | Moncton | New Brunswick | E1G 1A7 | Canada |
| Novartis Investigative Site | St. John's | Newfoundland and Labrador | A1A 3R5 | Canada |
| Novartis Investigative Site | Brampton | Ontario | L6T 0G1 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M9W 4L6 | Canada |
| Novartis Investigative Site | Mirabel | Quebec | J7J 2K8 | Canada |
| Novartis Investigative Site | Sainte-Foy | Quebec | G1W 4R4 | Canada |
| Novartis Investigative Site | Pozzilli | IS | 86077 | Italy |
| Novartis Investigative Site | Pavia | PV | 27100 | Italy |
| Novartis Investigative Site | Sassari | SS | 07100 | Italy |
| Novartis Investigative Site | Carolina | 00983 | Puerto Rico |
| Novartis Investigative Site | Cidra | 00739 | Puerto Rico |
| Novartis Investigative Site | Manati | 00674 | Puerto Rico |
| Novartis Investigative Site | Banská Bystrica | Slovak Republic | 97405 | Slovakia |
| Novartis Investigative Site | Bratislava | Slovak Republic | 83299 | Slovakia |
| Novartis Investigative Site | Košice | Slovak Republic | 040 11 | Slovakia |
| Novartis Investigative Site | Košice | Slovak Republic | 04001 | Slovakia |
| Novartis Investigative Site | Nitra | Slovak Republic | 95201 | Slovakia |
| Novartis Investigative Site | Rimavská Sobota | Slovak Republic | 97901 | Slovakia |
| Novartis Investigative Site | Senec | Slovak Republic | 90301 | Slovakia |
| Novartis Investigative Site | Snina | Slovak Republic | 09601 | Slovakia |
| Novartis Investigative Site | Svidník | Slovak Republic | 08901 | Slovakia |
| Novartis Investigative Site | Trnava | Slovak Republic | 91701 | Slovakia |
| Novartis Investigative Site | Bratislava | Slovakia | 821 07 | Slovakia |
| Novartis Investigative Site | Martin | Slovakia | 036 01 | Slovakia |
| Novartis Investigative Site | Prešov | Slovakia | 080 01 | Slovakia |
| Novartis Investigative Site | Šaľa | Slovakia | 927 03 | Slovakia |
| Novartis Investigative Site | Zvolen | Slovakia | 960 01 | Slovakia |
| Novartis Investigative Site | Barcelona | Catalonia | 08905 | Spain |
| Novartis Investigative Site | Centelles | Catalonia | 08540 | Spain |
| Novartis Investigative Site | Corbera de Llobregat | Catalonia | 08757 | Spain |
| Novartis Investigative Site | Hostalets de Balenya | Catalonia | 08550 | Spain |
| Novartis Investigative Site | Vic | Catalonia | 08500 | Spain |
| Novartis Investigative Site | Madrid | Madrid | 28009 | Spain |
| Novartis Investigative Site | Alzira | Valencia | 46600 | Spain |
| Novartis Investigative Site | Quart de Poblet | Valencia | 46930 | Spain |
| Novartis Investigative Site | Taichung | Taiwan | 40447 | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan | 10002 | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan | 114 | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan, ROC | 112 | Taiwan |
| Novartis Investigative Site | Changhua | 500 | Taiwan |
| Safety and Full Analysis Set (FAS) |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
All Randomized patients (including one mis-randomized patient in Aliskiren:Fed arm).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Aliskiren: Fed | Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast |
| BG001 | Aliskiren: Fasting | Aliskiren 300 mg once daily taken after after an overnight fast |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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 |
| |||||||||||||||
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP) | 24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maSBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate. | Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with ABPM measurements at both baseline and week 8 were included in this analysis. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline, week 8 |
|
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| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP) | 24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maDBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate. | Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with ABPM measurements at both baseline and week 8 were included in this analysis. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline, week 8 |
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| Secondary | Percentage of Patients Achieving Blood Pressure Control | Patients achieving blood pressure control were patients who, at week 8, had a mean sitting systolic blood pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) < 140/90 mmHg | Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with mean sitting blood pressure measurement over 8 weeks were included in this analysis. | Posted | Number | Percentage of patients | 8 weeks |
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| Secondary | Change From Baseline (Visit 3) to End of Study (8 Weeks) in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | Sitting blood pressure (BP) was measured at trough (approximately 24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the BP was checked in both arms and the arm with higher systolic BP (SBP) was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures (msSBP and msDBP) were measured four times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 2 minute intervals and the mean of all four sitting blood pressure measurements was used as the average sitting office blood pressure for that visit. The analysis of covariance (ANCOVA) model used treatment, region as factors, and baseline as covariate. | Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with official mean sitting blood pressure measurements both at baseline and week 8 were icluded in this analysis. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline, Week 8 |
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| Secondary | Percentage of Patients Achieving a Successful Response in Systolic Blood Pressure Reduction | Successful response in systolic blood pressure reduction at end of 8-week treatment was defined as msSBP <140 mmHg or a reduction in msSBP ≥ 20 mmHg from baseline. | Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with mean sitting SBP measurement at baseline and over 8 weeks were included in this analysis. | Posted | Number | Percentage of patients | Baseline, Week 8 |
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| Secondary | Pharmacokinetic (PK) of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration in Fasted vs. Fed | Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis. | Pharmacokinetics set included all patients who had evaluable aliskiren concentration data with no protocol deviations that presumably affect PK results were included in the pharmacokinetic evaluations | Posted | Mean | Standard Deviation | ng/mL | Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) |
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| Secondary | Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) in Fasted vs. Fed | Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis. | Pharmacokinetics set included all patients who had evaluable aliskiren concentration data with no protocol deviations that presumably affect PK results were included in the pharmacokinetic evaluations. | Posted | Mean | Standard Deviation | ng*h/mL | Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) |
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| Secondary | Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration in Fasted vs. Fed | Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis. | Pharmacokinetics set included all patients who had evaluable aliskiren concentration data with no protocol deviations that presumably affect PK results were included in the pharmacokinetic evaluations. | Posted | Mean | Standard Deviation | Hour | Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) |
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| Secondary | Change From Baseline to Week 8 in Plasma Renin Activity (PRA) | Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin activity (PRA) . Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8).The difference between baseline and week 8 was calculated. | Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with both baseline and week 8 measurement for PRA are included in this analysis. | Posted | Mean | Standard Deviation | ng/mL/hr | Baseline, Week 8 |
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| Secondary | Change From Baseline to Week 8 in Plasma Renin Concentration (PRC) | Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin concentration (PRC). Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8). The difference between baseline and week 8 was calculated. | Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with both baseline and week 8 measurement for PRC are included in this analysis. | Posted | Mean | Standard Deviation | ng/L | Baseline, Week 8 |
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| Secondary | Number of Patients With Adverse Events, Serious Adverse Events and Death | Safety Set (SAF): consisted of all patients who received at least one dose of randomized study medication. | Posted | Number | Patients | 8 weeks |
|
|
Not provided
Safety Set (SAF): consisted of all patients who received at least one dose of randomized study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aliskiren: Fed | Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast | 4 | 295 | 3 | 295 | ||
| EG001 | Aliskiren 300 mg (Fasted) | Aliskiren 300 mg once daily taken after after an overnight fast | 2 | 294 | 16 | 294 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery stenosis | Cardiac disorders | MedDRA | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Staphylococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Overdose | 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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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal 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 or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | trialandresults.registries@novartis.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C446481 | aliskiren |
Not provided
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Not provided
| Male |
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