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This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amlodipine 10 mg | Experimental | Amlodipine 10 mg |
|
| Aliskiren/Amlodipine 150/10 mg | Experimental | Aliskiren/Amlodipine 150/10 mg |
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| Aliskiren/Amlodipine 300/10 mg | Experimental | Aliskiren/Amlodipine 300/10 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine 10 mg | Drug | Amlodipine 10 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study | Baseline and Week 8 | |
| Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | N | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Buenos Aires | Argentina | ||||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22303911 | Derived | Pfeiffer D, Rennie N, Papst CC, Zhang J. Efficacy and tolerability of aliskiren/amlodipine single-pill combinations in patients who did not respond fully to amlodipine monotherapy yen. Curr Vasc Pharmacol. 2012 Nov;10(6):773-80. doi: 10.2174/157016112803520945. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aliskiren/Amlodipine 300/10 mg | Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning |
| FG001 | Aliskiren/Amlodipine 150/10 mg | Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Aliskiren 150 | Drug | Aliskiren/Amlodipine 150/10 mg |
|
| Amlodipine 300 | Drug | Aliskiren/Amlodipine 300/10 mg |
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| Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS) | 12 weeks |
| Berlin |
| Germany |
| Investigative Site | Oslo | Norway |
| Investigative Site | Warsaw | Poland |
| Investigative Site | Bratislava | Slovakia |
| Investigative Site | Stockholm | Sweden |
| Investigative Site | Ankara | Turkey (Türkiye) |
| FG002 | Amlodipine 10 mg | Oral capsules of amlodipine 10 mg taken once daily with water in the morning |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aliskiren/Amlodipine 300/10 mg | Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning |
| BG001 | Aliskiren/Amlodipine 150/10 mg | Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning |
| BG002 | Amlodipine 10 mg | Oral capsules of amlodipine 10 mg taken once daily with water in the morning |
| BG003 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| 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 Diastolic Blood Pressure (msDBP) From Baseline to End of Study | full analysis set | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline and Week 8 |
|
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| ||||||||||||||||||||||||||||||||
| Secondary | Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study | full analysis set | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline and Week 8 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group | Analysis: Intention to Treat (ITT) Imputation Technique: Last Observation Carried Forward (LOCF) | Posted | Number | Participants | 8 weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS) | Not Posted | 12 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 300mg/ Amlodipine 10mg | Aliskiren 300mg/ Amlodipine 10mg | 4 | 279 | 31 | 279 | ||
| EG001 | Aliskiren 150mg/ Amlodipine 10mg | Aliskiren 150mg/ Amlodipine 10mg | 1 | 283 | 35 | 283 | ||
| EG002 | Amlodipine 10mg | Amlodipine 10mg | 0 | 281 | 40 | 281 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphoid tissue hyperplasia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Renal artery stenosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 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 |
|---|---|
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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