Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension
- Conditions
- Hypertension
- Interventions
- Drug: Valsartan/amlodipine 80/5 mg
- Registration Number
- NCT00413049
- Lead Sponsor
- Novartis
- Brief Summary
This study will evaluate 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
- 698
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Valsartan/amlodipine 80/5 mg Valsartan/amlodipine 80/5 mg - Amlodipine 5 mg Amlodipine 5 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. A negative change score indicates lowered BP.
- 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. A negative change score indicates lowered BP.
Percentage of Patients Achieving a Diastolic Response at the End of the Study (Week 8) Baseline to end of study (Week 8) A patient achieved a diastolic response if their msDBP \< 90 mmHg at Week 8 or they had a ≥ 10 mmHg decrease in msDBP 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 Control at the End of the Study (Week 8) Baseline to end of study (Week 8) A patient achieved diastolic control if their 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 Control at the End of the Study (Week 8) Baseline to end of study (Week 8) A patient achieved overall control if the 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.
Change in 24-hour Mean Ambulatory Diastolic and Systolic BP From Baseline at the End of the Study (Week 8) Baseline to end of study (Week 8) Two 24 hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline prior to randomization and one at Week 8 (end of study), in a subset of the intent-to-treat population of patients. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient. A correlation was made between the ABPM device readings and measurements taken with a mercury sphygmomanometer and stethoscope. Following the correlation procedure, BP was measured at study specified intervals. A negative change score indicates lowered BP.
Trial Locations
- Locations (12)
Institute of Hypertension, Ruijin Hospital
🇨🇳Shanghai, China
Zhongshan hospital affiliated Fudan University
🇨🇳Shanghai, China
The sixth people's hospital of Shanghai
🇨🇳Shanghai, China
The first hospital affiliated school of medical of Xi'an Jiaotong University
🇨🇳Xi'an, China
Union hospital affiliated Fujian medical University
🇨🇳Fuzhou, China
The third Xiangya hospital of central south University
🇨🇳Changsha, China
The first hospital affiliated the third military Medical University
🇨🇳Chongqing, China
The third hospital affiliated the third military Medical University
🇨🇳Chongqing, China
China-Japan Friendship Hospital
🇨🇳Beijing, China
People's hospital affiliated Beijing University
🇨🇳Beijing, China
The first hospital affiliated Fujian medical University
🇨🇳Fuzhou, China
The second hospital affiliated Jiangxi medical school
🇨🇳Nanchang, China