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

Chong Kun Dang

Status and phase: Terminated; Phase 4

Conditions: Hypertension

Treatments: Drug: Candemore tablet; Drug: Cozzar tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01766505

m111HHF11F

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 2 patient groups

Candemore tablet

Experimental group

Description:

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

Treatment:

Drug: Candemore tablet

Cozzar tablet

Active Comparator group

Description:

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

Treatment:

Drug: Cozzar tablet