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To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure [msDBP] ≥ 90 mmHg and < 110 mmHg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aliskiren/Amlodipine | Experimental |
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| Aliskiren/Amlodipine/HCTZ | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug | All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Percentage of Patients With Adverse Events | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points | Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54 | |
| Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg |
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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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Santa Fe | New Mexico | United States | |||
| Investigator Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19257800 | Derived | Littlejohn TW 3rd, Trenkwalder P, Hollanders G, Zhao Y, Liao W. Long-term safety, tolerability and efficacy of combination therapy with aliskiren and amlodipine in patients with hypertension. Curr Med Res Opin. 2009 Apr;25(4):951-9. doi: 10.1185/03007990902785845. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aliskiren/Amlodipine | Aliskiren and Amlodipine tablets once a day in the morning |
| FG001 | Aliskiren/Amlodipine/HCTZ | Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Amlodipine | Drug | All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration |
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| Hydrochlorothiazide | Drug | Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled. |
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| Baseline, Week 2, Week 10, Week 28 and Week 54 |
| Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline, Week 2, Week 10, Week 28 and Week 54 |
| Investigative Site |
| Belgium |
| Investigative Center | Investigative Center | Denmark |
| Investigative Site | Investigative Site | Finland |
| Investigative Center | Investigative Center | Germany |
| Investigative Site | Investigative Site | Iceland |
| Investigative Site | Investigative Site | India |
| Investigative Site | Investigative Site | Switzerland |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aliskiren/Amlodipine | Aliskiren and Amlodipine tablets once a day in the morning |
| BG001 | Aliskiren/Amlodipine/HCTZ | Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning |
| 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 | Overall Percentage of Patients With Adverse Events | Treated Population | Posted | Number | Percentage of Participants | 52 weeks |
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| Secondary | Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points | Treated population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination. | Posted | Mean | Standard Deviation | mm Hg | Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54 |
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| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg | Treated Population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination. | Posted | Number | Percentage of patients | Baseline, Week 2, Week 10, Week 28 and Week 54 |
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| Secondary | Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP) | Treated Population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination. | Posted | Number | Percentage of patients | Baseline, Week 2, Week 10, Week 28 and Week 54 |
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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 150mg/ Amlodipine 5mg Alone | Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning | 0 | 556 | 14 | 556 | ||
| EG001 | Aliskiren 300mg/ Amlodipine 10mg Alone | Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning | 13 | 546 | 138 | 546 | ||
| EG002 | Aliskiren 300mg/ Amlodipine 10mg/ HCTZ | Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning | 2 | 86 | 21 | 86 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Intestinal ischaemia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Amoebiasis | Infections and infestations | MedDRA | Systematic Assessment |
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| Gangrene | Infections and infestations | MedDRA | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
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| Post procedural infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Ligament injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Pubic rami fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypovolaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
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| Hypotension | Vascular 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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| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue 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 |
| D017311 | Amlodipine |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
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