FOCUS (Nifedipine GITS's Effect on Central Pressure Assessed by Applanation Tonometry)

Study Overview
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Brief Summary
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To determine whether the combination of nifedipine GITS and valsartan is more effective in reducing central blood pressure than nifedipine GITS or valsartan alone, and to determine whether nifedipine GITS is comparable to valsartan

Official Title
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A Prospective, Open-label, Active-controlled, Randomized Study Comparing Nifedipine GITS Versus Valsartan Versus a Combination of Both on Central Blood Pressure in Inadequately Controlled Essential Hypertension.

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Nifedipine (Adalat, BAYA1040) and Valsartan
* Drug: Nifedipine (Adalat, BAYA1040)
* Drug: Valsartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Untreated grade 2 or grade 3 hypertension defined by mean diastolic blood pressure (BP) >/= 100 and/or mean systolic BP >/= 160mmHg without anti-hypertensive treatment or Treated grade 2 hypertension defined by mean diastolic BP >/= 100 and/or mean systolic BP >/=160mmHg with current diuretics and/or beta-blockers use for >/= 4 weeks Exclusion Criteria: Secondary form of hypertension Mean systolic BP >/= 200mmHg and or mean diastolic BP >/= 120mmHg Treated with other antihypertensive medication except diuretics or beta-blockers Type 1 diabetes mellitus Known cardiovascular disease including history of angina pectoris, heart failure, history of myocardial infarction or revascularization procedure, or cerebrovascular disease (including stroke and transient ischaemic attack) within the previous 12 months Renal insufficiency defined as a serum creatinine: >/= 1.7 mg/dl Pregnancy or not using contraceptive in childbearing aged women Breast feeding women Any disease or condition that in the opinion of the investigator may interfere with completion of the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: Arm 1<br> | Drug: Nifedipine (Adalat, BAYA1040) and Valsartan<br>* Combination treatment with nifedipine GITS 30mg and valsartan 80mg, Once daily<br>|
| Active Comparator: Arm 2<br> | Drug: Nifedipine (Adalat, BAYA1040)<br>* Nifedipine 60mg, Once daily<br>|
| Active Comparator: Arm 3<br> | Drug: Valsartan<br>* Valsartan 160mg, Once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central systolic blood pressure |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in central diastolic blood pressure and pulse pressure |  | Week 4,8 | 
| Change in central systolic blood pressure |  | Week 4 | 
| Change in brachial systolic blood pressure and diastolic blood pressure |  | Week 4,8 | 
| Change in brachial pulse pressure |  | Week4,8 | 
| Change in augmentation index and augmentation pressure |  | Week 4,8 | 
| Response rate(≥10 mmHg decrease of brachial SBP and ≥5mmHg decrease of brachial DBP) |  | Week 4,8 | 
| Control rate (≤140/90 mmHg, 130/80 mmHg for diabetes, of brachial BP |  | Week 4,8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central blood pressure, Nifedipine, Valsartan