To Evaluate the Efficacy and Safety on Blood Pressure In Patients With Hypertension Diagnosed Congestive Heart Failure

Study Overview
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Brief Summary
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To compare and evaluate the efficacy and safety of Candemore tab. versus Atacand tab. on blood pressure in patients with hypertension diagnosed congestive heart failure

Detailed Description
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This is an open label, randomized, active drug comparative, Parallel group, Multi-center, phase IV study. Patients receive candemore tablet or atacand tablet. Initial dose is 4mg/day or 8mg/day. Every 2 weeks, patients take double dose if patients blood pressure is measured SBP ≥ 100mmHg and DBP > 60mmHg. Maximum dose is 16mg/day.

Official Title
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Open Label, Randomized, Active Drug Comparative, Parallel Group, Multi-center, Phase IV Study to Compare and Evaluate the Efficacy and Safety of Candemore Tab and Atacand Tab.

Conditions
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Hypertension, Congestive Heart Failure

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: willing and able to provide written informed consent age 20 years or older patient with congestive heart failure, taking treatment medicine and NYHA grade II III patient with hypertension, taking treatment medicine or SBP ≥ 140mmHg or DBP ≥ 90mmHg at the screening visit Exclusion Criteria: Known or suspected secondary hypertension(ex. aortic coactation, primary hyperaldosteronism, renal artery stenosis, pheochromocytoma, cushing syndrome, polycystic renal disease) blood creatinine level ≥ 2.5mg/dl blood potassium level > 5.5mEq/L blood SGOT, SGPT level ≥ maximum normal range X3 or patient with sever hepatic dysfunction, cholestasis pregnant or breast-feeding premenopausal women not using adequate contraception patient has history about hypersensitivity or taboo of investigational product patient with lactose intolerance or Lapp lactase deficiency or glucode-galactose malabsorption administration of other study drugs within 1 month prior to screening history of ischemic heart disease(ex. angina pectoris, myocardial infarction) within the last 3 months in investigator's judgement

Ages Eligible for Study
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Minimum Age: 20 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 Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day) | Drug: Candemore tablet<br>* Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day)<br>|
| Active Comparator: Atacand tablet<br>Atacand tablet Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day) | Drug: Atacand tablet<br>* Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean sitting Systolic Blood Pressure |  | After 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Sitting Diastolic Blood Pressure |  | After 12 weeks of treatment | 
| echocardiography | Left Ventricle Volume, Left Ventricle Ejection Fraction, E/E' ration, Peak TR velocity | After 12 weeks of treatment | 
| Blood Creatinine and Potssium level |  | After 4 and 12 weeks of treatment | 
| NYHA class |  | After 12 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Candemore, Atacand, Candesartan cilexetil, Primary Hypertension, Congestive Hypertension