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
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 April 14, 2014