To Evaluate the Efficacy and Safety on Blood Pressure In Patients With Hypertension Diagnosed Congestive Heart Failure
CANTABILE
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.
1 other identifier
interventional
169
1 country
14
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hypertension
Started Jan 2012
Typical duration for phase_4 hypertension
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 4, 2012
CompletedFirst Posted
Study publicly available on registry
September 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedSeptember 24, 2015
September 1, 2015
2.8 years
September 4, 2012
September 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean sitting Systolic Blood Pressure
After 12 weeks of treatment
Secondary Outcomes (4)
Mean Sitting Diastolic Blood Pressure
After 12 weeks of treatment
echocardiography
After 12 weeks of treatment
Blood Creatinine and Potssium level
After 4 and 12 weeks of treatment
NYHA class
After 12 weeks of treatment
Study Arms (2)
Candemore tablet
EXPERIMENTALCandemore 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
ACTIVE COMPARATORAtacand 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
* 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)
* 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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Inje university pusan hospital
Busan, Busanjin-gu Gaegum-dong, 614-735, South Korea
Gyeongsang national university hospital
Jinju, Chiram-dong, 660-702, South Korea
Daegu fatima hospital
Daegu, Dong-gu Sinam-dong, 701-724, South Korea
Daedong hospital
Busan, Dongnae-gu Myeongnyun-dong, 607-711, South Korea
Inje university haeundae paik hospital
Busan, Haeundae-gu Heaundae-ro 875, 612-030, South Korea
Maryknoll medical center
Busan, Jung-gu Daecheong-dong, 600-730, South Korea
Keimyung university dongsan medical center
Daegu, Jung-gu Dongsan-dong, 700-712, South Korea
Kyungpook national university hospital
Daegu, Jung-gu Samdeok-dong, 700-721, South Korea
Samsung changwon hospital
Changwon, Masanhoiwon-gu Hapseong-dong 50, 630-723, South Korea
Yeungnam university medical center
Daegu, Nam-gu Daemyeong-dong, 705-717, South Korea
Daegu catholic univ. medical center
Daegu, Nam-gu Daemyung-dong, 705-718, South Korea
Kosin university gospel hospital
Busan, Seo-gu Amnam-dong, 602-702, South Korea
Dong-A university medical center
Busan, Seo-gu Dongdaesin-dong, 602-715, South Korea
Dongguk university gyeongju hospital
Gyeongju, Seokjang-dong, 780-350, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
KeeSik Kim, M.D Ph.D
Daegu Catholic University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2012
First Posted
September 11, 2012
Study Start
January 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
September 24, 2015
Record last verified: 2015-09