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

NCT ID: NCT01766505

Last Updated: 2014-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Candemore tablet

Candemore tablet: candesartan cilexetil 8mg, 16mg, 32mg/tab, orally, 1 tablet once a day during 16 weeks

Group Type EXPERIMENTAL

Candemore tablet

Intervention Type DRUG

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 tablet

Cozzar tablet: Losartan potassium 50mg, 100mg/cap, orally, 1 capsule once a day during 16 weeks

Group Type ACTIVE_COMPARATOR

Cozzar tablet

Intervention Type DRUG

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

Interventions

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Candemore tablet

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

Cozzar tablet

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Myungho Jeong, phD

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Locations

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Chungnam national university hospital

Daejeon, , South Korea

Site Status

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

Daejeon, , South Korea

Site Status

Konyang university hospital

Daejeon, , South Korea

Site Status

Eulji University Hospital

Daejeon, , South Korea

Site Status

Chunnam National University Hospital

Gwangju, , South Korea

Site Status

Kwangju Christian Hospital

Gwangju, , South Korea

Site Status

Presbyterian Medical Center

Jeonju, , South Korea

Site Status

Chunbuk National University Hospital

Jeonju, , South Korea

Site Status

ST.Carollo hospital

Suncheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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m111HHF11F

Identifier Type: -

Identifier Source: org_study_id

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