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

Hypertension Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01766505
• Other study ID #: m111HHF11F
• Status: Terminated
• Phase: Phase 4
• First received: January 10, 2013
• Last updated: March 12, 2014
• Start date: June 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Hypertension

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Chunbuk National University Hospital	Chonju
Korea, Republic of	Presbyterian Medical Center	Chunju
Korea, Republic of	Chungnam national university hospital	Daejeon
Korea, Republic of	Eulji University Hospital	Daejeon
Korea, Republic of	The catholic university of Korea, Daejeon st. Mary's Hospital	Daejeon
Korea, Republic of	Konyang university hospital	Daejon
Korea, Republic of	Chunnam National University Hospital	Gwangju
Korea, Republic of	Kwangju Christian Hospital	Gwangju
Korea, Republic of	ST.Carollo hospital	Suncheon

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	rate of adverse event		up to 16 weeks	Yes
Other	medication history		up to 16 weeks	Yes
Primary	change from baseline average sitting DBP(diastolic blood pressure)at 16 weeks		baseline, 16 weeks	No
Secondary	change from baseline average sitting DBP(diastolic blood pressure)at 8 weeks		baseline, 8 weeks	No
Secondary	change from baseline average sitting SBP(systolic blood pressure)at 8 weeks		baseline, 8 weeks	No
Secondary	change from baseline average sitting SBP(systolic blood pressure)at 16 weeks		baseline, 16 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	change from baseline LVEF(left ventricular ejection fraction at 16 weeks		baseline, 16 weeks	No
Secondary	change from baseline LVEDD(left ventricular end-diastolic diameter)at 16 weeks		baseline, 16 weeks	No
Secondary	change from baseline LV(left ventricular) mass at 16 weeks		baseline, 16 weeks	No
Secondary	change from baseline PWV(pulse wave velocity) mass at 16 weeks		baseline, 16 weeks	No