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

Phase 4

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Candemore tablet	Candemore tablet	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)
Atacand tablet	Atacand tablet	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)

Primary Outcome Measures

Name	Time	Method
Mean sitting Systolic Blood Pressure	After 12 weeks of treatment

Secondary Outcome Measures

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

Locations (14): Daegu catholic univ. medical center
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Daegu, Nam-gu Daemyung-dong, Korea, Republic of
Maryknoll medical center
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Busan, Jung-gu Daecheong-dong, Korea, Republic of
Gyeongsang national university hospital
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Jinju, Chiram-dong, Korea, Republic of
Inje university pusan hospital
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Busan, Busanjin-gu Gaegum-dong, Korea, Republic of
Kyungpook national university hospital
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Daegu, Jung-gu Samdeok-dong, Korea, Republic of
Keimyung university dongsan medical center
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Daegu, Jung-gu Dongsan-dong, Korea, Republic of
Daegu fatima hospital
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Daegu, Dong-gu Sinam-dong, Korea, Republic of
Daedong hospital
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Busan, Dongnae-gu Myeongnyun-dong, Korea, Republic of
Inje university haeundae paik hospital
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Busan, Haeundae-gu Heaundae-ro 875, Korea, Republic of
Samsung changwon hospital
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Changwon, Masanhoiwon-gu Hapseong-dong 50, Korea, Republic of
Yeungnam university medical center
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Daegu, Nam-gu Daemyeong-dong, Korea, Republic of
Dong-A university medical center
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Busan, Seo-gu Dongdaesin-dong, Korea, Republic of
Kosin university gospel hospital
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Busan, Seo-gu Amnam-dong, Korea, Republic of
Dongguk university gyeongju hospital
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Gyeongju, Seokjang-dong, Korea, Republic of