Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients

Study Overview
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Brief Summary
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The purpose of this study was to compare the efficacy and safety of Valsartan/Amlodipine (EXforge®) with nifedipine, as well as vascular function index.

Official Title
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A 12 Weeks, Multi-center, Open Label, Randomized, Active Drug Parallel Control Trial to Compare the Effectiveness of Valsartan/Amlodipine and Nifedipine in Treating Chinese Hypertensive Patients Not Respond to Mono Antihypertensive Treatment

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Valsartan/Amlodipine
* Drug: Nifedipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female adult outpatients had uncontrolled hypertension at both screening and randomization despite current antihypertensive monotherapy (initial dose of Angiotensin Receptor Blockers (ARB), Angiotensin Converting Enzyme Inhibitors (ACEI), Calcium Channel Blockers (CCB), diuretics or β receptor blocker) Exclusion Criteria: Systolic BP (SBP) level ≥160 mm Hg (≥160 mm Hg in diabetics) or a diastolic BP (DBP) level ≥110 mm Hg (≥100 mm Hg in diabetics) at any time between screening and randomization. Patients with type 1 diabetes or poorly controlled type 2 diabetes (glycosylated hemoglobin >8.0%) Patients had evidence of hepatic disease or renal impairment Other exclusion criteria included evidence of secondary hypertension or history of cardio-vascular disease. Women who were pregnant, nursing, or of childbearing potential and not using acceptable contraception. Other protocol-defined inclusion/exclusion criteria applied.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valsartan/amlodipine<br>Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks. | Drug: Valsartan/Amlodipine<br>* Valsartan/Amlodipine 80/5mg single pill combination (SPC)<br>* Other names: Exforge®;|
| Active Comparator: Nifedipine<br>Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks. | Drug: Nifedipine<br>* Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg<br>* Other names: Adalat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 weeks | 
| 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. | 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. | 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. | Baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Valsartan Amlodipine single pill combination, BP control, ABPM, Hypertensive patients not adequately controlled by mono antihypertensive drugs