The Study to Evaluate Efficacy and Safety of Candesartan vs Losartan in Hypertension With Heart Failure (HONOR)

Study Overview
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Brief Summary
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The purpose of this study is to compare efficacy and safety of candesartan and losartan in hypertension with heart failure.

Detailed Description
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This is a randomized, open-label, phase 4 study. wash out periods need at least 14 days if the patients take ARB or ACE inhibitor to control Blood pressure. Patients take Candemore or Cozzar once a day during 16 weeks.

Official Title
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Randomized, Open-label, Phase 4 Study to Evaluate Efficacy and Safety of Candesartan and Losartan in the Patients With Hypertension and Heart Failure.

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Candemore tablet
* Drug: Cozzar tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female and male patients who aged above 19 and below 75 Patients with 90 109mmHg average sitting DBP on baseline NYHA class 2 4 Patients who agreement with written informed consent Exclusion Criteria: above 110mmHg sitting DBP and/or 180mmHg sitting SBP Patients who have difference values that above 20mmHg sitting SBP or 10mmHg sitting DBP in both arms on screening Patients who have medical history that secondary hypertension or rule out secondary hypertension malignant hypertension symptomatic postural hypotension right heart failure due to pulmonary disease etc.

Ages Eligible for Study
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Minimum Age: 19 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Candemore tablet<br>Candemore tablet: candesartan cilexetil 8mg, 16mg, 32mg/tab, orally, 1 tablet once a day during 16 weeks | Drug: Candemore tablet<br>* Candemore tablet 8, 16, or 32mg/tab, per oral, a tablet once a day during 16 weeks. dosage is depends on the sitting blood pressure.<br>|
| Active Comparator: Cozzar tablet<br>Cozzar tablet: Losartan potassium 50mg, 100mg/cap, orally, 1 capsule once a day during 16 weeks | Drug: Cozzar tablet<br>* Cozzar tablet: 8mg, 16mg, 32mg/tablet, per oral, a tablet a day during 16 weeks dosage depends on sitting blood pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline average sitting DBP(diastolic blood pressure)at 16 weeks |  | baseline, 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline average sitting DBP(diastolic blood pressure)at 8 weeks |  | baseline, 8 weeks | 
| change from baseline average sitting SBP(systolic blood pressure)at 8 weeks |  | baseline, 8 weeks | 
| change from baseline average sitting SBP(systolic blood pressure)at 16 weeks |  | baseline, 16 weeks | 
| ratio of normalize from baseline blood pressure at 16 weeks | normalize means that sitting SBP and DBP is below 140mmHg and 90mmHg | baseline, 16 weeks | 
| response ratio from baseline blood pressure at 16 weeks | response means that decrease in sitting DBP and SBP is above 10mmHg and 20mmHg | baseline, 16 weeks | 
| change from baseline LVEF(left ventricular ejection fraction at 16 weeks |  | baseline, 16 weeks | 
| change from baseline LVEDD(left ventricular end-diastolic diameter)at 16 weeks |  | baseline, 16 weeks | 
| change from baseline LV(left ventricular) mass at 16 weeks |  | baseline, 16 weeks | 
| change from baseline PWV(pulse wave velocity) mass at 16 weeks |  | baseline, 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, heart failure, candesartan, losartan