Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Amlodipine (Optional)
Amlodipine · 5 trials · 1 indication
Systolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msSBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures Analysis of Covariance (ANCOVA) model with treatment, visit, and region as factors, treatment by visit interaction and baseline msSBP as a covariate.
Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region as factors, treatment by visit interaction and baseline msSBP as a covariate.
At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
| Arm | Type | Description |
|---|---|---|
| Aliskiren + Amlodipine | EXPERIMENTAL | Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks. |
| Aliskiren Start - Amlodipine Add-On | EXPERIMENTAL | Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks. |
| Amlodipine Start- Aliskiren Add-On | EXPERIMENTAL | Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks. |
| Amlodipine 10 mg | EXPERIMENTAL | Amlodipine 10 mg |
| Aliskiren/Amlodipine 150/10 mg | EXPERIMENTAL | Aliskiren/Amlodipine 150/10 mg |
| Aliskiren/Amlodipine 300/10 mg | EXPERIMENTAL | Aliskiren/Amlodipine 300/10 mg |
| Amlodipine/Valsartan 5/80 mg | EXPERIMENTAL | 1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily |
| Amlodipine/Valsartan 5/40 mg | ACTIVE_COMPARATOR | 1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily |
| Amlodipine 5 mg | ACTIVE_COMPARATOR | 1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily |
| Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ | EXPERIMENTAL | During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg. |
| Name | Type | Description |
|---|---|---|
| Amlodipine | DRUG | Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily. |
| hydrochlorothiazide | DRUG | Hydrochlorothiazide 12.5 mg capsules were taken orally once daily |
| Aliskiren | DRUG | Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily. |
| Amlodipine 10 mg | DRUG | Amlodipine 10 mg |
| Aliskiren 150 | DRUG | Aliskiren/Amlodipine 150/10 mg |
| Amlodipine 300 | DRUG | Aliskiren/Amlodipine 300/10 mg |
| Amlodipine 5 mg | DRUG | 1 capsule amlodipine 5 mg orally once daily |
| Valsartan 80 mg | DRUG | 1 capsule valsartan 80 mg orally once daily |
| Valsartan 40 mg | DRUG | 1 capsule valsartan 40 mg orally once daily |
| Placebo | DRUG | 1 capsule placebo to match valsartan orally once daily |
| Olmesartan medoxomil | DRUG | Olmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only. |
| Amlodipine+valsartan | DRUG | Fixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally once a day during Treatment Phase 2 and Extension Phase. |
| amlodipine/benazepril | DRUG | - |
Inclusion Criteria: * Male or female outpatients ≥ 18 years of age * Participants with essential hypertension: * Naive participants must have a mean sitting Systolic Blood Pressure (msSBP) ≥ 150 mmHg and \< 180 mmHg at Visit 1 and Visit 2. (Participants are considered 'naïve' if they have never ...