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

Novartis Pharmaceuticals1,134 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,134

Conditions

Hypertension

Interventions

Valsartan/amlodipine 80/5 mgDRUG

1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily

Valsartan 80 mgDRUG

1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily

Valsartan 160 mgDRUG

1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (19)

Beijing ChaoYang Hospital, Affiliate of Capital University of Medical Sciences

Beijing, China

Outcomes

Primary Outcomes

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.

Time frame: Baseline to end of study (Week 8)

Secondary Outcomes

Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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