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
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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COMPLETED
PHASE4
169 participants
INTERVENTIONAL
2012-01-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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)
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
* 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
* 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)
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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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
Gyeongsang national university hospital
Jinju, Chiram-dong, South Korea
Daegu fatima hospital
Daegu, Dong-gu Sinam-dong, South Korea
Daedong hospital
Busan, Dongnae-gu Myeongnyun-dong, South Korea
Inje university haeundae paik hospital
Busan, Haeundae-gu Heaundae-ro 875, South Korea
Maryknoll medical center
Busan, Jung-gu Daecheong-dong, South Korea
Keimyung university dongsan medical center
Daegu, Jung-gu Dongsan-dong, South Korea
Kyungpook national university hospital
Daegu, Jung-gu Samdeok-dong, South Korea
Samsung changwon hospital
Changwon, Masanhoiwon-gu Hapseong-dong 50, South Korea
Yeungnam university medical center
Daegu, Nam-gu Daemyeong-dong, South Korea
Daegu catholic univ. medical center
Daegu, Nam-gu Daemyung-dong, South Korea
Kosin university gospel hospital
Busan, Seo-gu Amnam-dong, South Korea
Dong-A university medical center
Busan, Seo-gu Dongdaesin-dong, South Korea
Dongguk university gyeongju hospital
Gyeongju, Seokjang-dong, South Korea
Countries
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Other Identifiers
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m106CHF11E
Identifier Type: -
Identifier Source: org_study_id
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