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

NCT ID: NCT01682564

Last Updated: 2015-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-10-31

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.

Conditions

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Hypertension Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Candemore tablet

Intervention Type DRUG

* 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

* 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)

Group Type ACTIVE_COMPARATOR

Atacand tablet

Intervention Type DRUG

* 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)

Interventions

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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)

Intervention Type DRUG

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)

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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KeeSik Kim, M.D Ph.D

Role: PRINCIPAL_INVESTIGATOR

Daegu Catholic University Medical Center

Locations

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Inje university pusan hospital

Busan, Busanjin-gu Gaegum-dong, South Korea

Site Status

Gyeongsang national university hospital

Jinju, Chiram-dong, South Korea

Site Status

Daegu fatima hospital

Daegu, Dong-gu Sinam-dong, South Korea

Site Status

Daedong hospital

Busan, Dongnae-gu Myeongnyun-dong, South Korea

Site Status

Inje university haeundae paik hospital

Busan, Haeundae-gu Heaundae-ro 875, South Korea

Site Status

Maryknoll medical center

Busan, Jung-gu Daecheong-dong, South Korea

Site Status

Keimyung university dongsan medical center

Daegu, Jung-gu Dongsan-dong, South Korea

Site Status

Kyungpook national university hospital

Daegu, Jung-gu Samdeok-dong, South Korea

Site Status

Samsung changwon hospital

Changwon, Masanhoiwon-gu Hapseong-dong 50, South Korea

Site Status

Yeungnam university medical center

Daegu, Nam-gu Daemyeong-dong, South Korea

Site Status

Daegu catholic univ. medical center

Daegu, Nam-gu Daemyung-dong, South Korea

Site Status

Kosin university gospel hospital

Busan, Seo-gu Amnam-dong, South Korea

Site Status

Dong-A university medical center

Busan, Seo-gu Dongdaesin-dong, South Korea

Site Status

Dongguk university gyeongju hospital

Gyeongju, Seokjang-dong, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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m106CHF11E

Identifier Type: -

Identifier Source: org_study_id

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