Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00523744 | Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension | PHASE3 | COMPLETED | 257 | — | — | Jul 1, 2007 | Dec 1, 2007 | Aug 4, 2020 | 2 | Germany, |
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 |
|---|---|---|
| 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 supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only. |
| 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. |
| Hydrochlorothiazide | DRUG | Hydrochlorothiazide (HCTZ) 12.5 mg tablets taken once a day during the Extension Phase. |
Inclusion Criteria for Core study: * Male or female patients (\>=18 years) * Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods * Patients with essential hypertension (diastolic blood pressure \>=100 mmHg and \<110 mmHg) Inclusion Crite...