Essential Hypertension ( Mild to Moderate)
Conditions
Keywords
Essential Hypertension ( mild to moderate)
Brief summary
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).
Interventions
DRUGAliskiren
Aliskiren 150 or 300 mg
DRUGHydrochlorothiazide
Hydrochlorothiazide 12.5 or 25 mg
DRUGAmlodipine
Amlodipine 5 or 10 mg
Sponsors
Novartis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Outpatients ≥ 18 years of age * Patients with a diagnosis of mild to moderate hypertension at Visit 1 * All patients must have a msSBP ≥ 140 mmHg and \< 180 mmHg and/or msDBP ≥ 90 mmHg and \< 110 mmHg mmHg at Visit 3
Exclusion criteria
* Severe hypertension defined as msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg * Secondary form of hypertension * Current diagnosis of heart failure (NYHA Class II-IV) * Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates) * Second or third degree heart block without a pacemaker * Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1 Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen | 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 24 weeks | 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. |
| 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] | 24 weeks | 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). |
Countries
France, Hungary, Romania, Slovakia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 256 |
| Total | 256 |
Baseline characteristics
| Characteristic | Aliskiren-based Regimen |
|---|---|
| Age, Customized < 65 yrs | 203 participants |
| Age, Customized ≥ 65 yrs | 53 participants |
| Sex: Female, Male Female | 113 Participants |
| Sex: Female, Male Male | 143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 256 | 0 / 197 | 0 / 119 |
| serious Total, serious adverse events | 3 / 256 | 0 / 197 | 0 / 119 |
Outcome results
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.
Time frame: 24 weeks
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aliskiren-based Regimen | Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen | 86.12 Percentage of participants |
Secondary
Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP]
Time frame: Baseline and Week 24
Population: Full analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aliskiren-based Regimen | Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP] | msSBP | -25.33 mm Hg | Standard Deviation 13.942 |
| Aliskiren-based Regimen | Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP] | msDBP | -12.40 mm Hg | Standard Deviation 9.371 |
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.
Time frame: 24 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aliskiren-based Regimen | 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. | Mild Hypertensive | 91.48 Percentage of Participants |
| Aliskiren-based Regimen | 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. | Moderate Hypertensive | 79.24 Percentage of Participants |
| Aliskiren-based Regimen | 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. | Non-diabetic | 92.74 Percentage of Participants |
| Aliskiren-based Regimen | 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. | Diabetic | 72.58 Percentage of Participants |
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).
Time frame: 24 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aliskiren-based Regimen | Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP] | msSBP | 96.80 Percentage of Participants |
| Aliskiren-based Regimen | Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP] | msDBP | 97.78 Percentage of Participants |