Candesartan Effectiveness Study in Pro-B Type Natriuretic Peptides (BNP)

Study Overview
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Brief Summary
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The purpose of this study is to investigate effect of candesartan based therapy on percent change of B type natriuretic peptides(BNP) level in the subjects with hypertension and left ventricular hypertrophy.

Official Title
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A Multicenter, Non-comparative, Phase IV Study to Evaluate the Effect of Candesartan Based Therapy in the Percent Change of proBNP Level After 24 Week Treatment in the Patients With Hypertension With Left Ventricular Hypertrophy

Conditions
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Hypertension, Left Ventricular Hypertrophy

Intervention / Treatment
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* Drug: Candesartan
* Drug: Candesartan
* Drug: Felodipine
* Drug: Felodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hypertension with diastolic blood pressure within 95-115 mm/Hg or/and systolic blood pressure within 160-200 mm/Hg Patients diagnosed as left ventricular hypertrophy by electrocardiogram Exclusion Criteria: Secondary hypertension History of myocardial infarction Stroke within the previous 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Candesartan<br>Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures. | Drug: Candesartan<br>* 16 mg once daily in oral tablet form<br>* Other names: Atacand;Drug: Candesartan<br>* 32 mg once daily in oral tablet form<br>* Other names: Antacand;Drug: Felodipine<br>* 5 mg once daily in oral tablet form<br>Drug: Felodipine<br>* 10 mg once daily in oral tablet form<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change of B Type Natriuretic Peptides (BNP) Level | Change of B Type Natriuretic Peptides Level of the Subjects With Hypertension and Left Ventricular Hypertrophy (LVH) Treated With Candesartan Based Therapy for 24 Weeks was calculated just as the later time point minus the earlier time point. No specific calculation was used. | At Baseline and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVH(Left Ventricular Hypertrophy) Regression by Echocardiac Parameter, Left Ventricular Mass Index | Change of Left Ventricular Hypertrophy(LVH) by Echocardiac Parameter, Left Ventricular mass Index (LVMI) was calculated and collected through the way of Last Observational carried forward. LVH/Index was calculated like this: Divide LV mass with Body Surface Area. | At Baseline and 24 weeks | 
| Change of Systolic Blood Pressure (SBP) | Change of Systolic Blood Pressure was calculated and collected through the way of Last Observational carried forward. | At Baseline and 24 weeks | 
| Change of Diastolic Blood Pressure (DBP) | Change of Diastolic Blood Pressure was calculated and collected through the way of Last Observational carried forward. Only who has diastolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data. | At Baseline and 24 weeks | 
| Percent Change of proBNP(B Type Natriuretic Peptides) in Patients Treated With Candesartan Only | Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward. | At Baseline and 24 weeks | 
| Percent Change of proBNP(B Type Natriuretic Peptides) in Patients With Candesartan Plus Felodipine | Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward. | At Baseline and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LVH