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This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aliskiren/amlodipine 300/10 mg tablet | Experimental | Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg. |
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| Amlodipine 10 mg capsule | Active Comparator | Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren/amlodipine 300/10 mg tablet | Drug | Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Sitting Systolic Blood Pressure (msSBP) | 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 |
|---|---|---|
| Mean Sitting Diastolic Blood Pressure (msDBP) | Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of study (Week 8) | Baseline to end of study (Week 8) |
| Systolic Blood Pressure Response |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Berlin | Germany | ||||
| Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aliskiren/Amlodipine 300/10 mg Tablet | Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Amlodipine 10 mg capsule | Drug | Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study. |
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Percentage of patients achieving a mean sitting systolic blood pressure response (msSBP < 140 mmHg or a reduction => 20 mmHg from the baseline) from baseline to end of study (Week 8)
| Baseline to end of study (Week 8) |
| Diastolic Blood Pressure Response | Percentage of patients achieving a mean sitting diastolic blood pressure response (msDBP < 90 mmHg or a reduction ≥ 10 mmHg from the baseline) from baseline to end of study (Week 8) | Baseline to end of study (Week 8) |
| Blood Pressure Control | Percentage of patients achieving blood pressure control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at end of study | End of study (Week 8) |
| Manila |
| Philippines |
| Investigative Site | Bucharest | Romania |
| Investigative Site | Moscow | Russia |
| Investigative Site | Singapore | Singapore |
| Investigative Site | Madrid | Spain |
| Amlodipine 10 mg Capsule |
Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aliskiren/Amlodipine 300/10 mg Tablet | Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg. |
| BG001 | Amlodipine 10 mg Capsule | Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg. |
| 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 |
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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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Sitting Systolic Blood Pressure (msSBP) | Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8) | Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline to end of study (Week 8) |
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| Secondary | Mean Sitting Diastolic Blood Pressure (msDBP) | Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of study (Week 8) | Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline to end of study (Week 8) |
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| Secondary | Systolic Blood Pressure Response | Percentage of patients achieving a mean sitting systolic blood pressure response (msSBP < 140 mmHg or a reduction => 20 mmHg from the baseline) from baseline to end of study (Week 8) | Full Analysis Set - analysis set was the FAS excluding patients from one center due to GCP issues | Posted | Number | Percentage of participants | Baseline to end of study (Week 8) |
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| Secondary | Diastolic Blood Pressure Response | Percentage of patients achieving a mean sitting diastolic blood pressure response (msDBP < 90 mmHg or a reduction ≥ 10 mmHg from the baseline) from baseline to end of study (Week 8) | Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues All randomized patients who received the study medication. The measurement at Week 8 was used unless it was not available, in which case, the last observation carried forward was used. | Posted | Number | Percentage of participants | Baseline to end of study (Week 8) |
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| Secondary | Blood Pressure Control | Percentage of patients achieving blood pressure control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at end of study | Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues | Posted | Number | Percentage of participants | End of study (Week 8) |
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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/Amlodipine 300/10 mg Tablet | Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg. | 0 | 243 | 41 | 243 | ||
| EG001 | Amlodipine 10 mg Capsule | Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg. | 3 | 241 | 56 | 241 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
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| Adenomyosis | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
| D017311 | Amlodipine |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Male |
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| Participants |
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