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

This study has been terminated.
(lack of the subjects)
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01766505
First received: January 10, 2013
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: Candemore tablet
Drug: Cozzar tablet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Open-label, Phase 4 Study to Evaluate Efficacy and Safety of Candesartan and Losartan in the Patients With Hypertension and Heart Failure.

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • change from baseline average sitting DBP(diastolic blood pressure)at 16 weeks [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change from baseline average sitting DBP(diastolic blood pressure)at 8 weeks [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
  • change from baseline average sitting SBP(systolic blood pressure)at 8 weeks [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
  • change from baseline average sitting SBP(systolic blood pressure)at 16 weeks [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
  • ratio of normalize from baseline blood pressure at 16 weeks [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
    normalize means that sitting SBP and DBP is below 140mmHg and 90mmHg

  • response ratio from baseline blood pressure at 16 weeks [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
  • change from baseline LVEDD(left ventricular end-diastolic diameter)at 16 weeks [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
  • change from baseline LV(left ventricular) mass at 16 weeks [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
  • change from baseline PWV(pulse wave velocity) mass at 16 weeks [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • rate of adverse event [ Time Frame: up to 16 weeks ] [ Designated as safety issue: Yes ]
  • medication history [ Time Frame: up to 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: June 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Other Name: Candemore tablet
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
Other Name: 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.

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766505

Locations
Korea, Republic of
Chunbuk National University Hospital
Chonju, Korea, Republic of, 561-712
Presbyterian Medical Center
Chunju, Korea, Republic of, 560-750
The catholic university of Korea, Daejeon st. Mary's Hospital
Daejeon, Korea, Republic of, 301-723
Eulji University Hospital
Daejeon, Korea, Republic of, 302-799
Chungnam national university hospital
Daejeon, Korea, Republic of, 301-721
Konyang university hospital
Daejon, Korea, Republic of, 302-718
Chunnam National University Hospital
Gwangju, Korea, Republic of, 501-757
Kwangju Christian Hospital
Gwangju, Korea, Republic of, 503-715
ST.Carollo hospital
Suncheon, Korea, Republic of, 540-719
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Myungho Jeong, phD Chonnam National University Hospital
  More Information

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01766505     History of Changes
Other Study ID Numbers: m111HHF11F
Study First Received: January 10, 2013
Last Updated: March 12, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Chong Kun Dang Pharmaceutical:
hypertension, heart failure, candesartan, losartan

Additional relevant MeSH terms:
Heart Failure
Hypertension
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Losartan
Candesartan
Candesartan cilexetil
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014