The purpose of this study was to compare the efficacy and safety of Valsartan/Amlodipine (EXforge®) with nifedipine, as well as vascular function index.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
564
Valsartan/Amlodipine 80/5mg single pill combination (SPC)
Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg
Novartis Pharmaceuticals
Beijing, China
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks)
The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher mean sitting diastolic blood pressure (MSDBP) was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.
Time frame: Baseline, 12 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks)
The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher msDBP was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.
Time frame: Baseline, 12 weeks
Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks)
Effective SBP control rate was defined as proportion of subjects in whom MSSBP \< 140 mmHg or MSSBP reduction ≥ 20 mmHg from baseline. Effective DBP control rate was defined as proportion of subjects in whom MSDBP \< 90 mmHg or MSDBP reduction ≥10 mmHg from baseline.
Time frame: Baseline, 12 weeks
Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks
Blood Pressure (BP) target was defined as mean sitting BP\<140/90 mm Hg in non-diabetic patients and\<130/80 mm Hg in diabetic patients at 12 weeks.
Time frame: 12 weeks
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Change From Baseline in Orthostatic SBP and DBP at 12 Weeks
The arm with higher sitting blood pressure was selected for all examinations throughout the study. Orthostatic blood pressure was measured when subject stood for 1 minute. Orthostatic blood pressures were measured at screening and each visit.
Time frame: Baseline, 12 weeks
Change From Baseline in Sitting Pulse at 12 Weeks
Sitting pulse was measured by sphygmomanometer after subject sat for 5 minutes at clinic during each visit.
Time frame: Baseline, 12 weeks
Change From Baseline in Orthostatic Pulse at 12 Weeks
Orthostatic pulse was measured by sphygmomanometer when subject stood for 1 minute at clinic during each visit.
Time frame: Baseline, 12 weeks