Clinical trial NCT01766505: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypertension
Keywords: hypertension, heart failure, candesartan, losartan
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-01-11
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: change from baseline average sitting DBP(diastolic blood pressure)at 16 weeks
timeFrame: baseline, 16 weeks
Secondary outcomes:
measure: change from baseline average sitting DBP(diastolic blood pressure)at 8 weeks
timeFrame: baseline, 8 weeks
measure: change from baseline average sitting SBP(systolic blood pressure)at 8 weeks
timeFrame: baseline, 8 weeks
measure: change from baseline average sitting SBP(systolic blood pressure)at 16 weeks
timeFrame: baseline, 16 weeks
measure: ratio of normalize from baseline blood pressure at 16 weeks
timeFrame: baseline, 16 weeks
measure: response ratio from baseline blood pressure at 16 weeks
timeFrame: baseline, 16 weeks
measure: change from baseline LVEF(left ventricular ejection fraction at 16 weeks
timeFrame: baseline, 16 weeks
measure: change from baseline LVEDD(left ventricular end-diastolic diameter)at 16 weeks
timeFrame: baseline, 16 weeks
measure: change from baseline LV(left ventricular) mass at 16 weeks
timeFrame: baseline, 16 weeks
measure: change from baseline PWV(pulse wave velocity) mass at 16 weeks
timeFrame: baseline, 16 weeks
Other outcomes:
measure: rate of adverse event
timeFrame: up to 16 weeks
measure: medication history
timeFrame: up to 16 weeks
Locations:
city: Chonju
country: Korea, Republic of
facility: Chunbuk National University Hospital
city: Chunju
country: Korea, Republic of
facility: Presbyterian Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam national university hospital
city: Daejeon
country: Korea, Republic of
facility: The catholic university of Korea, Daejeon st. Mary's Hospital
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital
city: Daejon
country: Korea, Republic of
facility: Konyang university hospital
city: Gwangju
country: Korea, Republic of
facility: Chunnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital
city: Suncheon
country: Korea, Republic of
facility: ST.Carollo hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Myungho Jeong, phD
role: PRINCIPAL_INVESTIGATOR
References: