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

Phase 4TerminatedNCT01766505

Chong Kun Dang Pharmaceutical32 enrolled

Overview

The purpose of this study is to compare efficacy and safety of candesartan and losartan in hypertension with heart failure.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

Candemore tabletDRUG

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.

Cozzar tabletDRUG

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (9)

Chungnam national university hospital

Daejeon, South Korea

The catholic university of Korea, Daejeon st. Mary's Hospital

Daejeon, South Korea

Konyang university hospital

Daejeon, South Korea

Eulji University Hospital

Outcomes

Primary Outcomes

change from baseline average sitting DBP(diastolic blood pressure)at 16 weeks

Time frame: baseline, 16 weeks

Secondary Outcomes

change from baseline average sitting DBP(diastolic blood pressure)at 8 weeks

Time frame: baseline, 8 weeks

change from baseline average sitting SBP(systolic blood pressure)at 8 weeks

Time frame: baseline, 8 weeks

change from baseline average sitting SBP(systolic blood pressure)at 16 weeks

Time frame: baseline, 16 weeks

ratio of normalize from baseline blood pressure at 16 weeks

normalize means that sitting SBP and DBP is below 140mmHg and 90mmHg

Time frame: baseline, 16 weeks

response ratio from baseline blood pressure at 16 weeks

response means that decrease in sitting DBP and SBP is above 10mmHg and 20mmHg

Time frame: baseline, 16 weeks

change from baseline LVEF(left ventricular ejection fraction at 16 weeks

Time frame: baseline, 16 weeks

change from baseline LVEDD(left ventricular end-diastolic diameter)at 16 weeks

Time frame: baseline, 16 weeks

change from baseline LV(left ventricular) mass at 16 weeks

Time frame: baseline, 16 weeks

change from baseline PWV(pulse wave velocity) mass at 16 weeks

Data from ClinicalTrials.gov

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