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The Study to Evaluate Efficacy and Safety of Candesartan vs Losartan in Hypertension With Heart Failure (HONOR)

Randomized, Open-label, Phase 4 Study to Evaluate Efficacy and Safety of Candesartan and Losartan in the Patients With Hypertension and Heart Failure.

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01766505
Enrollment
32
Registered
2013-01-11
Start date
2012-06-30
Completion date
2014-03-31
Last updated
2014-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension, heart failure, candesartan, losartan

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.

Interventions

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.

DRUGCozzar tablet

Cozzar tablet: 8mg, 16mg, 32mg/tablet, per oral, a tablet a day during 16 weeks dosage depends on sitting blood pressure

Sponsors

Chong Kun Dang Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
change from baseline average sitting DBP(diastolic blood pressure)at 16 weeksbaseline, 16 weeks

Secondary

MeasureTime frameDescription
change from baseline average sitting DBP(diastolic blood pressure)at 8 weeksbaseline, 8 weeks
change from baseline average sitting SBP(systolic blood pressure)at 8 weeksbaseline, 8 weeks
change from baseline average sitting SBP(systolic blood pressure)at 16 weeksbaseline, 16 weeks
ratio of normalize from baseline blood pressure at 16 weeksbaseline, 16 weeksnormalize means that sitting SBP and DBP is below 140mmHg and 90mmHg
response ratio from baseline blood pressure at 16 weeksbaseline, 16 weeksresponse means that decrease in sitting DBP and SBP is above 10mmHg and 20mmHg
change from baseline LV(left ventricular) mass at 16 weeksbaseline, 16 weeks
change from baseline PWV(pulse wave velocity) mass at 16 weeksbaseline, 16 weeks
change from baseline LVEF(left ventricular ejection fraction at 16 weeksbaseline, 16 weeks
change from baseline LVEDD(left ventricular end-diastolic diameter)at 16 weeksbaseline, 16 weeks

Other

MeasureTime frame
rate of adverse eventup to 16 weeks
medication historyup to 16 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026