Clinical trial NCT01682564: To Evaluate the Efficacy and Safety on Blood Pressure In Patients With Hypertension Diagnosed Congestive Heart Failure
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Congestive Heart Failure
Keywords: Candemore
Atacand
Candesartan cilexetil
Primary Hypertension
Congestive Hypertension
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-09-11
Enrollment: 169
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean sitting Systolic Blood Pressure
timeFrame: After 12 weeks of treatment
Secondary outcomes:
measure: Mean Sitting Diastolic Blood Pressure
timeFrame: After 12 weeks of treatment
measure: echocardiography
timeFrame: After 12 weeks of treatment
measure: Blood Creatinine and Potssium level
timeFrame: After 4 and 12 weeks of treatment
measure: NYHA class
timeFrame: After 12 weeks of treatment
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje university pusan hospital
state: Busanjin-gu Gaegum-dong
city: Jinju
country: Korea, Republic of
facility: Gyeongsang national university hospital
state: Chiram-dong
city: Daegu
country: Korea, Republic of
facility: Daegu fatima hospital
state: Dong-gu Sinam-dong
city: Busan
country: Korea, Republic of
facility: Daedong hospital
state: Dongnae-gu Myeongnyun-dong
city: Busan
country: Korea, Republic of
facility: Inje university haeundae paik hospital
state: Haeundae-gu Heaundae-ro 875
city: Busan
country: Korea, Republic of
facility: Maryknoll medical center
state: Jung-gu Daecheong-dong
city: Daegu
country: Korea, Republic of
facility: Keimyung university dongsan medical center
state: Jung-gu Dongsan-dong
city: Daegu
country: Korea, Republic of
facility: Kyungpook national university hospital
state: Jung-gu Samdeok-dong
city: Changwon
country: Korea, Republic of
facility: Samsung changwon hospital
state: Masanhoiwon-gu Hapseong-dong 50
city: Daegu
country: Korea, Republic of
facility: Yeungnam university medical center
state: Nam-gu Daemyeong-dong
city: Daegu
country: Korea, Republic of
facility: Daegu catholic univ. medical center
state: Nam-gu Daemyung-dong
city: Busan
country: Korea, Republic of
facility: Kosin university gospel hospital
state: Seo-gu Amnam-dong
city: Busan
country: Korea, Republic of
facility: Dong-A university medical center
state: Seo-gu Dongdaesin-dong
city: Gyeongju
country: Korea, Republic of
facility: Dongguk university gyeongju hospital
state: Seokjang-dong
Study officials:
affiliation: Daegu Catholic University Medical Center
name: KeeSik Kim, M.D Ph.D
role: PRINCIPAL_INVESTIGATOR
References: