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

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ClinicalTrials.gov Identifier: NCT01682564
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Tracking Information
First Submitted Date  ICMJE September 4, 2012
First Posted Date  ICMJE September 11, 2012
Last Update Posted Date September 24, 2015
Study Start Date  ICMJE January 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
Mean sitting Systolic Blood Pressure [ Time Frame: After 12 weeks of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01682564 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
  • Mean Sitting Diastolic Blood Pressure [ Time Frame: After 12 weeks of treatment ]
  • echocardiography [ Time Frame: After 12 weeks of treatment ]
    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 ]
  • NYHA class [ Time Frame: After 12 weeks of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate the Efficacy and Safety on Blood Pressure In Patients With Hypertension Diagnosed Congestive Heart Failure
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Congestive Heart Failure
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • 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)
    Intervention: Drug: 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)
    Intervention: Drug: Atacand tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2015)
169
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2012)
200
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01682564
Other Study ID Numbers  ICMJE m106CHF11E
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chong Kun Dang Pharmaceutical
Study Sponsor  ICMJE Chong Kun Dang Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: KeeSik Kim, M.D Ph.D Daegu Catholic University Medical Center
PRS Account Chong Kun Dang Pharmaceutical
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP