Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT00413413
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1134
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Valsartan 160 mg Valsartan 160 mg - Valsartan/amlodipine 80/5 mg Valsartan/amlodipine 80/5 mg - Valsartan 80 mg Valsartan 80 mg -
- Primary Outcome Measures
Name Time Method Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) 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.
- Secondary Outcome Measures
Name Time Method Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) 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.
Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8) Baseline to end of 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.
Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8) End of 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.
Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8) End of 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.
Trial Locations
- Locations (19)
Department of cardiology, Ruijin hospital;
🇨🇳Shanghai, China
Second Hospital of Hebei University of Medical Sciences
🇨🇳Shijiazhuang, China
Beijing General Hospital of Beijing Military Region
🇨🇳Beijing, China
The First Affiliated Hospital of Medical College of Zhejiang University
🇨🇳Hangzhou, China
The First Affiliated Hospital of China Medical University
🇨🇳Shenyang, China
Department of cardiology, Ruijin hospital
🇨🇳Shanghai, China
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
The First People's Hospital of Hangzhou
🇨🇳Hangzhou, China
The Second Affiliated Hospital of Medical College of Zhejiang University
🇨🇳Hangzhou, China
Second Military Medical University Affiliated Changhai Hospital
🇨🇳Shanghai, China
The People's Hospital of Hebei Provincial
🇨🇳Shijiazhuang, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
Beijing Hospital
🇨🇳Beijing, China
Beijing ChaoYang Hospital, Affiliate of Capital University of Medical Sciences
🇨🇳Beijing, China
The people's Hospital of Liaoning Province
🇨🇳Shenyang, China
Second Military Medical University Affiliated Changzheng Hospital
🇨🇳Shanghai, China
Fudan University affiliated zhongshan hospital
🇨🇳Shanghai, China
Southeast University Affiliated Zhong Da Hospital
🇨🇳Nanjing, China
The First Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, China