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This study will assess the efficacy of an aliskiren based treatment regimen in reaching blood pressure (BP) target in patients with mild to moderate hypertension. (defined as mean sitting Systolic Blood Pressure [msSBP] ≥ 140 mmHg and < 180 mmHg and/or mean sitting Diastolic Blood Pressure [msDBP] ≥ 90 and <110 mmHg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aliskiren-based regimen | Experimental | All pts starting on aliskiren 150 mg (uptitrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (uptitrated to 25 mg) and amlodipine 5 mg (uptitrated to 10 mg), as necessary to achieve the Blood Pressure goal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug | Aliskiren 150 or 300 mg |
| |
| Hydrochlorothiazide |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen | For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients. | For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Paris | France | ||||
| Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aliskiren-based Regimen | Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aliskiren-based Regimen | Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen | For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg. | Full analysis set | Posted | Number | Percentage of participants | 24 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 | Aliskiren treatment step |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
| D006852 | Hydrochlorothiazide |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
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| Drug |
Hydrochlorothiazide 12.5 or 25 mg |
|
| Amlodipine | Drug | Amlodipine 5 or 10 mg |
|
| 24 weeks |
| Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP] | Baseline and Week 24 |
| Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP] | Response for mean sitting Systolic Blood Pressure [msSBP] is defined as a reduction of ≥ 20 mmHg from baseline or mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg (non diabetics) or < 130 mmHg (diabetics). Response for mean sitting Diastolic Blood Pressure [msDBP] is defined as a reduction of ≥10 mmHg from baseline or mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg (non diabetic) or < 80 mmHg (diabetics). | 24 weeks |
| Budapest |
| Hungary |
| Investigative Site | Bucharest | Romania |
| Investigative Site | Bratislava | Slovakia |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients. | For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg. | Posted | Number | Percentage of Participants | 24 weeks |
|
|
|
| Secondary | Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP] | Full analysis set | Posted | Mean | Standard Deviation | mm Hg | Baseline and Week 24 |
|
|
|
| Secondary | Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP] | Response for mean sitting Systolic Blood Pressure [msSBP] is defined as a reduction of ≥ 20 mmHg from baseline or mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg (non diabetics) or < 130 mmHg (diabetics). Response for mean sitting Diastolic Blood Pressure [msDBP] is defined as a reduction of ≥10 mmHg from baseline or mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg (non diabetic) or < 80 mmHg (diabetics). | Posted | Number | Percentage of Participants | 24 weeks |
|
|
|
| 3 |
| 256 |
| 0 |
| 256 |
| EG001 | Aliskiren + HCTZ | Aliskiren and HCTZ treatment step | 0 | 197 | 0 | 197 |
| EG002 | Aliskiren + HCTZ + Amlodipine | Aliskiren + HCTZ + Amlodipine treatment step | 0 | 119 | 0 | 119 |
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
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.
| D013457 |
| Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| Title | Measurements |
|---|---|
|
| Diabetic |
|