Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension

Study Overview
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Brief Summary
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This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension.

Official Title
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A Multi-national, Multicenter, Double-blind, Double-dummy, Randomized, Active-controled, Parallel Study, Comparing Efficacy and Safety of Valsartan/Amlodipine 80/5 mg to Valsartan 80 mg and Valsartan 160 mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 80 mg Monotherapy.

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Valsartan/amlodipine 80/5 mg
* Drug: Valsartan 80 mg
* Drug: Valsartan 160 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients >= 18 years and < 86 years Patients with essential diastolic hypertension At visit 1, the patient must have mean sitting diastolic blood pressure >= 95 mmHg and < 10 mmHg; patients treated with antihypertensive medication must have a mean sitting diastolic blood pressure < 100 mmHg At visit 2, patients must have a mean sitting diastolic blood pressure of >= 95 mmHg and < 100 mmHg At visit 3, patients must have a mean sitting diastolic blood pressure of >= 90 mmHg and < 110 mmHg Exclusion Criteria: Severe hypertension >= 180/110 mmHg Known or suspected contraindications, including a history of allergy or hypersensitivity to valsartan or amlodipine or to other drugs with similar chemical structures Inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to Visit 2 History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or other types of revascularization Malignant hypertension All patients with Type I diabetes and those patients with Type 2 diabetes who are not well controlled based on the investigator's clinical judgment Pregnant or nursing women History of heart failure Angina pectoris Second or third degree heart block Life threatening or symptomatic arrhythmias Clinically significant valvular heart disease Evidence of a secondary form of hypertension Known or moderate malignant retinopathy Evidence of hepatic disease Evidence of renal impairment Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valsartan/amlodipine 80/5 mg<br> | Drug: Valsartan/amlodipine 80/5 mg<br>* 1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily<br>|
| Active Comparator: Valsartan 80 mg<br> | Drug: Valsartan 80 mg<br>* 1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily<br>|
| Active Comparator: Valsartan 160 mg<br> | Drug: Valsartan 160 mg<br>* 1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) | Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. | Baseline to end of study (Week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) | Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. | Baseline to end of study (Week 8) | 
| Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8) | A diastolic blood pressure response was defined as a msDBP < 90 mmHg or a ≥ 10 mmHg decrease compared to baseline at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. | Baseline to end of study (Week 8) | 
| Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8) | Diastolic blood pressure control was defined as a msDBP < 90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. | End of study (Week 8) | 
| Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8) | Overall blood pressure control rate was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. | End of study (Week 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, valsartan, amlodipine, high blood pressure