The Study to Evaluate Efficacy and Safety of Candesartan vs Losartan in Hypertension With Heart Failure (HONOR)
Primary Purpose
Hypertension
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Candemore tablet
Cozzar tablet
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring hypertension, heart failure, candesartan, losartan
Eligibility Criteria
Inclusion Criteria:
- Female and male patients who aged above 19 and below 75
- Patients with 90~109mmHg average sitting DBP on baseline
- NYHA class 2~4
- Patients who agreement with written informed consent
Exclusion Criteria:
- above 110mmHg sitting DBP and/or 180mmHg sitting SBP
- Patients who have difference values that above 20mmHg sitting SBP or 10mmHg sitting DBP in both arms on screening
- Patients who have medical history that secondary hypertension or rule out secondary hypertension
- malignant hypertension
- symptomatic postural hypotension
- right heart failure due to pulmonary disease
- etc.
Sites / Locations
- Chunbuk National University Hospital
- Presbyterian Medical Center
- Chungnam national university hospital
- The catholic university of Korea, Daejeon st. Mary's Hospital
- Eulji University Hospital
- Konyang university hospital
- Chunnam National University Hospital
- Kwangju Christian Hospital
- ST.Carollo hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Candemore tablet
Cozzar tablet
Arm Description
Candemore tablet: candesartan cilexetil 8mg, 16mg, 32mg/tab, orally, 1 tablet once a day during 16 weeks
Cozzar tablet: Losartan potassium 50mg, 100mg/cap, orally, 1 capsule once a day during 16 weeks
Outcomes
Primary Outcome Measures
change from baseline average sitting DBP(diastolic blood pressure)at 16 weeks
Secondary Outcome Measures
change from baseline average sitting DBP(diastolic blood pressure)at 8 weeks
change from baseline average sitting SBP(systolic blood pressure)at 8 weeks
change from baseline average sitting SBP(systolic blood pressure)at 16 weeks
ratio of normalize from baseline blood pressure at 16 weeks
normalize means that sitting SBP and DBP is below 140mmHg and 90mmHg
response ratio from baseline blood pressure at 16 weeks
response means that decrease in sitting DBP and SBP is above 10mmHg and 20mmHg
change from baseline LVEF(left ventricular ejection fraction at 16 weeks
change from baseline LVEDD(left ventricular end-diastolic diameter)at 16 weeks
change from baseline LV(left ventricular) mass at 16 weeks
change from baseline PWV(pulse wave velocity) mass at 16 weeks
Full Information
NCT ID
NCT01766505
First Posted
January 10, 2013
Last Updated
March 12, 2014
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT01766505
Brief Title
The Study to Evaluate Efficacy and Safety of Candesartan vs Losartan in Hypertension With Heart Failure (HONOR)
Official Title
Randomized, Open-label, Phase 4 Study to Evaluate Efficacy and Safety of Candesartan and Losartan in the Patients With Hypertension and Heart Failure.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
lack of the subjects
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 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
The purpose of this study is to compare efficacy and safety of candesartan and losartan in hypertension with heart failure.
Detailed Description
This is a randomized, open-label, phase 4 study. wash out periods need at least 14 days if the patients take ARB or ACE inhibitor to control Blood pressure. Patients take Candemore or Cozzar once a day during 16 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, heart failure, candesartan, losartan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Candemore tablet
Arm Type
Experimental
Arm Description
Candemore tablet: candesartan cilexetil 8mg, 16mg, 32mg/tab, orally, 1 tablet once a day during 16 weeks
Arm Title
Cozzar tablet
Arm Type
Active Comparator
Arm Description
Cozzar tablet: Losartan potassium 50mg, 100mg/cap, orally, 1 capsule once a day during 16 weeks
Intervention Type
Drug
Intervention Name(s)
Candemore tablet
Intervention Description
Candemore tablet 8, 16, or 32mg/tab, per oral, a tablet once a day during 16 weeks.
dosage is depends on the sitting blood pressure.
Intervention Type
Drug
Intervention Name(s)
Cozzar tablet
Intervention Description
Cozzar tablet: 8mg, 16mg, 32mg/tablet, per oral, a tablet a day during 16 weeks dosage depends on sitting blood pressure
Primary Outcome Measure Information:
Title
change from baseline average sitting DBP(diastolic blood pressure)at 16 weeks
Time Frame
baseline, 16 weeks
Secondary Outcome Measure Information:
Title
change from baseline average sitting DBP(diastolic blood pressure)at 8 weeks
Time Frame
baseline, 8 weeks
Title
change from baseline average sitting SBP(systolic blood pressure)at 8 weeks
Time Frame
baseline, 8 weeks
Title
change from baseline average sitting SBP(systolic blood pressure)at 16 weeks
Time Frame
baseline, 16 weeks
Title
ratio of normalize from baseline blood pressure at 16 weeks
Description
normalize means that sitting SBP and DBP is below 140mmHg and 90mmHg
Time Frame
baseline, 16 weeks
Title
response ratio from baseline blood pressure at 16 weeks
Description
response means that decrease in sitting DBP and SBP is above 10mmHg and 20mmHg
Time Frame
baseline, 16 weeks
Title
change from baseline LVEF(left ventricular ejection fraction at 16 weeks
Time Frame
baseline, 16 weeks
Title
change from baseline LVEDD(left ventricular end-diastolic diameter)at 16 weeks
Time Frame
baseline, 16 weeks
Title
change from baseline LV(left ventricular) mass at 16 weeks
Time Frame
baseline, 16 weeks
Title
change from baseline PWV(pulse wave velocity) mass at 16 weeks
Time Frame
baseline, 16 weeks
Other Pre-specified Outcome Measures:
Title
rate of adverse event
Time Frame
up to 16 weeks
Title
medication history
Time Frame
up to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female and male patients who aged above 19 and below 75
Patients with 90~109mmHg average sitting DBP on baseline
NYHA class 2~4
Patients who agreement with written informed consent
Exclusion Criteria:
above 110mmHg sitting DBP and/or 180mmHg sitting SBP
Patients who have difference values that above 20mmHg sitting SBP or 10mmHg sitting DBP in both arms on screening
Patients who have medical history that secondary hypertension or rule out secondary hypertension
malignant hypertension
symptomatic postural hypotension
right heart failure due to pulmonary disease
etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myungho Jeong, phD
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chunbuk National University Hospital
City
Chonju
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Presbyterian Medical Center
City
Chunju
ZIP/Postal Code
560-750
Country
Korea, Republic of
Facility Name
Chungnam national university hospital
City
Daejeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
The catholic university of Korea, Daejeon st. Mary's Hospital
City
Daejeon
ZIP/Postal Code
301-723
Country
Korea, Republic of
Facility Name
Eulji University Hospital
City
Daejeon
ZIP/Postal Code
302-799
Country
Korea, Republic of
Facility Name
Konyang university hospital
City
Daejon
ZIP/Postal Code
302-718
Country
Korea, Republic of
Facility Name
Chunnam National University Hospital
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Kwangju Christian Hospital
City
Gwangju
ZIP/Postal Code
503-715
Country
Korea, Republic of
Facility Name
ST.Carollo hospital
City
Suncheon
ZIP/Postal Code
540-719
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Study to Evaluate Efficacy and Safety of Candesartan vs Losartan in Hypertension With Heart Failure (HONOR)
We'll reach out to this number within 24 hrs