search
Back to results

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

Primary Purpose

Hypertension, Congestive Heart Failure

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Candemore tablet
Atacand tablet
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Candemore, Atacand, Candesartan cilexetil, Primary Hypertension, Congestive Hypertension

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inje university pusan hospital
  • Gyeongsang national university hospital
  • Daegu fatima hospital
  • Daedong hospital
  • Inje university haeundae paik hospital
  • Maryknoll medical center
  • Keimyung university dongsan medical center
  • Kyungpook national university hospital
  • Samsung changwon hospital
  • Yeungnam university medical center
  • Daegu catholic univ. medical center
  • Kosin university gospel hospital
  • Dong-A university medical center
  • Dongguk university gyeongju hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Candemore tablet

Atacand tablet

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Mean sitting Systolic Blood Pressure

Secondary Outcome Measures

Mean Sitting Diastolic Blood Pressure
echocardiography
Left Ventricle Volume, Left Ventricle Ejection Fraction, E/E' ration, Peak TR velocity
Blood Creatinine and Potssium level
NYHA class

Full Information

First Posted
September 4, 2012
Last Updated
September 22, 2015
Sponsor
Chong Kun Dang Pharmaceutical
search

1. Study Identification

Unique Protocol Identification Number
NCT01682564
Brief Title
To Evaluate the Efficacy and Safety on Blood Pressure In Patients With Hypertension Diagnosed Congestive Heart Failure
Acronym
CANTABILE
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Congestive Heart Failure
Keywords
Candemore, Atacand, Candesartan cilexetil, Primary Hypertension, Congestive Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Candemore tablet
Arm Type
Experimental
Arm Description
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)
Arm Title
Atacand tablet
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Candemore tablet
Intervention Description
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 Type
Drug
Intervention Name(s)
Atacand tablet
Intervention Description
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)
Primary Outcome Measure Information:
Title
Mean sitting Systolic Blood Pressure
Time Frame
After 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Mean Sitting Diastolic Blood Pressure
Time Frame
After 12 weeks of treatment
Title
echocardiography
Description
Left Ventricle Volume, Left Ventricle Ejection Fraction, E/E' ration, Peak TR velocity
Time Frame
After 12 weeks of treatment
Title
Blood Creatinine and Potssium level
Time Frame
After 4 and 12 weeks of treatment
Title
NYHA class
Time Frame
After 12 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KeeSik Kim, M.D Ph.D
Organizational Affiliation
Daegu Catholic University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje university pusan hospital
City
Busan
State/Province
Busanjin-gu Gaegum-dong
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Gyeongsang national university hospital
City
Jinju
State/Province
Chiram-dong
ZIP/Postal Code
660-702
Country
Korea, Republic of
Facility Name
Daegu fatima hospital
City
Daegu
State/Province
Dong-gu Sinam-dong
ZIP/Postal Code
701-724
Country
Korea, Republic of
Facility Name
Daedong hospital
City
Busan
State/Province
Dongnae-gu Myeongnyun-dong
ZIP/Postal Code
607-711
Country
Korea, Republic of
Facility Name
Inje university haeundae paik hospital
City
Busan
State/Province
Haeundae-gu Heaundae-ro 875
ZIP/Postal Code
612-030
Country
Korea, Republic of
Facility Name
Maryknoll medical center
City
Busan
State/Province
Jung-gu Daecheong-dong
ZIP/Postal Code
600-730
Country
Korea, Republic of
Facility Name
Keimyung university dongsan medical center
City
Daegu
State/Province
Jung-gu Dongsan-dong
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Kyungpook national university hospital
City
Daegu
State/Province
Jung-gu Samdeok-dong
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Samsung changwon hospital
City
Changwon
State/Province
Masanhoiwon-gu Hapseong-dong 50
ZIP/Postal Code
630-723
Country
Korea, Republic of
Facility Name
Yeungnam university medical center
City
Daegu
State/Province
Nam-gu Daemyeong-dong
ZIP/Postal Code
705-717
Country
Korea, Republic of
Facility Name
Daegu catholic univ. medical center
City
Daegu
State/Province
Nam-gu Daemyung-dong
ZIP/Postal Code
705-718
Country
Korea, Republic of
Facility Name
Kosin university gospel hospital
City
Busan
State/Province
Seo-gu Amnam-dong
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Dong-A university medical center
City
Busan
State/Province
Seo-gu Dongdaesin-dong
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Dongguk university gyeongju hospital
City
Gyeongju
State/Province
Seokjang-dong
ZIP/Postal Code
780-350
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs