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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Chong Kun Dang Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01682564
First received: September 4, 2012
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Hypertension
Congestive Heart Failure
Drug: Candemore tablet
Drug: Atacand tablet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Mean sitting Systolic Blood Pressure [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Sitting Diastolic Blood Pressure [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
  • echocardiography [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Left Ventricle Volume, Left Ventricle Ejection Fraction, E/E' ration, Peak TR velocity

  • Blood Creatinine and Potssium level [ Time Frame: After 4 and 12 weeks of treatment ] [ Designated as safety issue: Yes ]
  • NYHA class [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)
Drug: 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)
Other Name: Candemore tablet
Active Comparator: 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)
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)
Other Name: Atacand tablet

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682564

Contacts
Contact: KeeSik Kim, M.D Ph.D. +82-53-650-3010 kks7379@cu.ac.kr

Locations
Korea, Republic of
Inje university pusan hospital Recruiting
Busan, Busanjin-gu Gaegum-dong, Korea, Republic of, 614-735
Contact: Dong-Soo Kim, M.D Ph.D    +82-51-890-6039    dongskim@inje.ac.kr   
Principal Investigator: Dong-Soo Kim, M.D Ph.D         
Gyeongsang national university hospital Recruiting
Jinju, Chiram-dong, Korea, Republic of, 660-702
Contact: Choong Hwan Kwak, M.D    +82-10-8503-9755    cwakch@naver.com   
Principal Investigator: Choong Hwan Kwak, M.D         
Daegu fatima hospital Recruiting
Daegu, Dong-gu Sinam-dong, Korea, Republic of, 701-724
Contact: Byung-Chun Jung, M.D Ph.D    +82-53-940-7293    augustjbc@yahoo.co.kr   
Principal Investigator: Byung-Chun Jung, M.D Ph.D         
Daedong hospital Recruiting
Busan, Dongnae-gu Myeongnyun-dong, Korea, Republic of, 607-711
Contact: Byung Soo Kim, M.D Ph.D    +82-51-741-5083    kbsmd@unitel.co.kr   
Principal Investigator: Byung Soo Kim, M.D Ph.D         
Inje university haeundae paik hospital Recruiting
Busan, Haeundae-gu Heaundae-ro 875, Korea, Republic of, 612-030
Contact: Doo-il Kim, M.D Ph.D    +82-51-797-3050    jo1216@chollian.net   
Principal Investigator: Doo-il Kim, M.D Ph.D         
Maryknoll medical center Recruiting
Busan, Jung-gu Daecheong-dong, Korea, Republic of, 600-730
Contact: Tae Ik Kim, M.D    +82-51-461-2429    kimti2429@gmail.com   
Principal Investigator: Tae Ik Kim, M.D         
Keimyung university dongsan medical center Recruiting
Daegu, Jung-gu Dongsan-dong, Korea, Republic of, 700-712
Contact: Hyungseop Kim, M.D    +82-10-9351-938    khyungseop@dsmc.or.kr   
Principal Investigator: Hungseop Kim, M.D         
Kyungpook national university hospital Recruiting
Daegu, Jung-gu Samdeok-dong, Korea, Republic of, 700-721
Contact: Dong Hun Yang, M.D Ph.D    +82-10-3005-7547    ddhyang@knu.ac.kr   
Principal Investigator: Dong Hun Yang, M.D Ph.D         
Samsung changwon hospital Recruiting
Changwon, Masanhoiwon-gu Hapseong-dong 50, Korea, Republic of, 630-723
Contact: Juhyeon Oh, M.D Ph.D    +82-55-290-6054    ojh@korea.com   
Principal Investigator: Juhyeon Oh, M.D Ph.D         
Yeungnam university medical center Recruiting
Daegu, Nam-gu Daemyeong-dong, Korea, Republic of, 705-717
Contact: Dong Gu Shin, M.D Ph.D    +82-10-4761-9123    dgshin@med.yu.ac.kr   
Principal Investigator: Dong Gu Shin, M.D Ph.D         
Daegu catholic univ. medical center Recruiting
Daegu, Nam-gu Daemyung-dong, Korea, Republic of, 705-718
Contact: KeeSik Kim, M.D Ph.D    +82-53-650-3010    kks7379@cu.ac.kr   
Principal Investigator: KeeSik Kim, M.D Ph.D         
Kosin university gospel hospital Recruiting
Busan, Seo-gu Amnam-dong, Korea, Republic of, 602-702
Contact: Tae-joon Cha, M.D Ph.D    +82-51-990-6725    chatjn@gmail.com   
Principal Investigator: Tae-joon Cha, M.D Ph.D         
Dong-A university medical center Recruiting
Busan, Seo-gu Dongdaesin-dong, Korea, Republic of, 602-715
Contact: Tae Ho Park, M.D Ph.D    +82-51-240-2964    thpark@dau.ac.kr   
Principal Investigator: Tae Ho Park, M.D Ph.D         
Dongguk university gyeongju hospital Recruiting
Gyeongju, Seokjang-dong, Korea, Republic of, 780-350
Contact: Deuk-Young Nah, M.D    +82-54-770-8561    ptca@dongguk.ac.kr   
Principal Investigator: Deuk-Young Nah, M.D         
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: KeeSik Kim, M.D Ph.D Daegu Catholic University Medical Center
  More Information

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01682564     History of Changes
Other Study ID Numbers: m106CHF11E
Study First Received: September 4, 2012
Last Updated: September 6, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:
Candemore
Atacand
Candesartan cilexetil
Primary Hypertension
Congestive Hypertension

Additional relevant MeSH terms:
Heart Failure
Hypertension
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Candesartan cilexetil
Candesartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014