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

Phase 4

Terminated

• Conditions: Hypertension
• Interventions: Drug: Candemore tablet; Drug: Cozzar tablet

• Registration Number: NCT01766505
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-11
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-12
• Last Update Posted: 2014-03-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Candemore tablet	Candemore tablet	Candemore tablet: candesartan cilexetil 8mg, 16mg, 32mg/tab, orally, 1 tablet once a day during 16 weeks
Cozzar tablet	Cozzar tablet	Cozzar tablet: Losartan potassium 50mg, 100mg/cap, orally, 1 capsule once a day during 16 weeks

Primary Outcome Measures

Name	Time	Method
change from baseline average sitting DBP(diastolic blood pressure)at 16 weeks	baseline, 16 weeks

Secondary Outcome Measures

Name	Time	Method
change from baseline average sitting DBP(diastolic blood pressure)at 8 weeks	baseline, 8 weeks
change from baseline average sitting SBP(systolic blood pressure)at 8 weeks	baseline, 8 weeks
change from baseline average sitting SBP(systolic blood pressure)at 16 weeks	baseline, 16 weeks
ratio of normalize from baseline blood pressure at 16 weeks	baseline, 16 weeks	normalize means that sitting SBP and DBP is below 140mmHg and 90mmHg
change from baseline LVEDD(left ventricular end-diastolic diameter)at 16 weeks	baseline, 16 weeks
change from baseline LV(left ventricular) mass at 16 weeks	baseline, 16 weeks
change from baseline PWV(pulse wave velocity) mass at 16 weeks	baseline, 16 weeks
response ratio from baseline blood pressure at 16 weeks	baseline, 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	baseline, 16 weeks

Trial Locations

Locations (9)

Presbyterian Medical Center; 🇰🇷 Chunju, Korea, Republic of

Chunbuk National University Hospital; 🇰🇷 Chonju, Korea, Republic of

Chungnam national university hospital; 🇰🇷 Daejeon, Korea, Republic of

ST.Carollo hospital; 🇰🇷 Suncheon, Korea, Republic of

Kwangju Christian Hospital; 🇰🇷 Gwangju, Korea, Republic of

Chunnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Eulji University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Konyang university hospital; 🇰🇷 Daejon, Korea, Republic of

The catholic university of Korea, Daejeon st. Mary's Hospital; 🇰🇷 Daejeon, Korea, Republic of