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.

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

Study Overview

• Status: Terminated
• Conditions: Hypertension
• Intervention / Treatment: Drug: Candemore tablet; Drug: Cozzar tablet

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chonju, Korea, Republic of, 561-712
    • Chunbuk National University Hospital
  • Chunju, Korea, Republic of, 560-750
    • Presbyterian Medical Center
  • Daejeon, Korea, Republic of, 301-721
    • Chungnam National University Hospital
  • Daejeon, Korea, Republic of, 302-799
    • Eulji University Hospital
  • Daejeon, Korea, Republic of, 301-723
    • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Daejon, Korea, Republic of, 302-718
    • Konyang University Hospital
  • Gwangju, Korea, Republic of, 501-757
    • Chunnam National University Hospital
  • Gwangju, Korea, Republic of, 503-715
    • Kwangju Christian Hospital
  • Suncheon, Korea, Republic of, 540-719
    • St.Carollo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Candemore tablet; Candemore tablet: candesartan cilexetil 8mg, 16mg, 32mg/tab, orally, 1 tablet once a day during 16 weeks	Drug: 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.
Active Comparator: Cozzar tablet; Cozzar tablet: Losartan potassium 50mg, 100mg/cap, orally, 1 capsule once a day during 16 weeks	Drug: Cozzar tablet; Cozzar tablet: 8mg, 16mg, 32mg/tablet, per oral, a tablet a day during 16 weeks dosage depends on sitting blood pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change from baseline average sitting DBP(diastolic blood pressure)at 16 weeks	baseline, 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	normalize means that sitting SBP and DBP is below 140mmHg and 90mmHg	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	baseline, 16 weeks
change from baseline LVEF(left ventricular ejection fraction at 16 weeks		baseline, 16 weeks
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

Other Outcome Measures

Outcome Measure	Time Frame
rate of adverse event	up to 16 weeks
medication history	up to 16 weeks

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Myungho Jeong, phD, Chonnam National University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: January 10, 2013
• First Submitted That Met QC Criteria: January 10, 2013
• First Posted (Estimate): January 11, 2013

Study Record Updates

• Last Update Posted (Estimate): March 14, 2014
• Last Update Submitted That Met QC Criteria: March 12, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: hypertension, heart failure, candesartan, losartan
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Heart Failure; Hypertension
• Other Study ID Numbers: m111HHF11F