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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01682564
First received: September 4, 2012
Last updated: September 22, 2015
Last verified: September 2015
  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 ]

Enrollment: 169
Study Start Date: January 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (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)
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)

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   (Adult, Senior)
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

Locations
Korea, Republic of
Inje university pusan hospital
Busan, Busanjin-gu Gaegum-dong, Korea, Republic of, 614-735
Gyeongsang national university hospital
Jinju, Chiram-dong, Korea, Republic of, 660-702
Daegu fatima hospital
Daegu, Dong-gu Sinam-dong, Korea, Republic of, 701-724
Daedong hospital
Busan, Dongnae-gu Myeongnyun-dong, Korea, Republic of, 607-711
Inje university haeundae paik hospital
Busan, Haeundae-gu Heaundae-ro 875, Korea, Republic of, 612-030
Maryknoll medical center
Busan, Jung-gu Daecheong-dong, Korea, Republic of, 600-730
Keimyung university dongsan medical center
Daegu, Jung-gu Dongsan-dong, Korea, Republic of, 700-712
Kyungpook national university hospital
Daegu, Jung-gu Samdeok-dong, Korea, Republic of, 700-721
Samsung changwon hospital
Changwon, Masanhoiwon-gu Hapseong-dong 50, Korea, Republic of, 630-723
Yeungnam university medical center
Daegu, Nam-gu Daemyeong-dong, Korea, Republic of, 705-717
Daegu catholic univ. medical center
Daegu, Nam-gu Daemyung-dong, Korea, Republic of, 705-718
Kosin university gospel hospital
Busan, Seo-gu Amnam-dong, Korea, Republic of, 602-702
Dong-A university medical center
Busan, Seo-gu Dongdaesin-dong, Korea, Republic of, 602-715
Dongguk university gyeongju hospital
Gyeongju, Seokjang-dong, Korea, Republic of, 780-350
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: KeeSik Kim, M.D Ph.D Daegu Catholic University Medical Center
  More Information

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 22, 2015
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:
Hypertension
Heart Failure
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Candesartan cilexetil
Candesartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016