HypertensionPhase 4NCT01766505
The Study to Evaluate Efficacy and Safety of Candesartan vs Losartan in Hypertension With Heart Failure (HONOR)
A Phase 4 study testing Candemore tablet and Cozzar tablet in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 9 sites in South Korea.
Trial summary
The purpose of this study is to compare efficacy and safety of candesartan and losartan in hypertension with heart failure. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Candemore tablet and Cozzar tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Jun 2012to Mar 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Chungnam national university hospital
Daejeon, 301-721
The catholic university of Korea, Daejeon st. Mary's Hospital
Daejeon, 301-723
Konyang university hospital
Daejeon, 302-718
Eulji University Hospital
Daejeon, 302-799
Chunnam National University Hospital
Gwangju, 501-757
Kwangju Christian Hospital
Gwangju, 503-715
Presbyterian Medical Center
Jeonju, 560-750
Chunbuk National University Hospital
Jeonju, 561-712
ST.Carollo hospital
Suncheon, 540-719
About this study
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.
The purpose of this study is to compare efficacy and safety of candesartan and losartan in hypertension with heart failure.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Candemore tablet, Cozzar tablet
- Keywords
- hypertension, heart failure, candesartan, losartan
- Medical subject headings
- Hypertension, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candemore tabletDrug
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 tabletDrug
Cozzar tablet: 8mg, 16mg, 32mg/tablet, per oral, a tablet a day during 16 weeks dosage depends on sitting blood pressure
| Study group | Role | What they receive |
|---|---|---|
| Candemore tablet | Experimental | Candemore tablet: candesartan cilexetil 8mg, 16mg, 32mg/tab, orally, 1 tablet once a day during 16 weeks Receives: Drug: Candemore tablet |
| Cozzar tablet | Active comparator | Cozzar tablet: Losartan potassium 50mg, 100mg/cap, orally, 1 capsule once a day during 16 weeks Receives: Drug: Cozzar tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline average sitting DBP(diastolic blood pressure)at 16 weeks
Measured: baseline, 16 weeks
Secondary outcomes (9)
change from baseline average sitting DBP(diastolic blood pressure)at 8 weeks
Measured: baseline, 8 weeks
change from baseline average sitting SBP(systolic blood pressure)at 8 weeks
Measured: baseline, 8 weeks
change from baseline average sitting SBP(systolic blood pressure)at 16 weeks
Measured: 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
Measured: 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
Measured: baseline, 16 weeks
change from baseline LVEF(left ventricular ejection fraction at 16 weeks
Measured: baseline, 16 weeks
change from baseline LVEDD(left ventricular end-diastolic diameter)at 16 weeks
Measured: baseline, 16 weeks
change from baseline LV(left ventricular) mass at 16 weeks
Measured: baseline, 16 weeks
change from baseline PWV(pulse wave velocity) mass at 16 weeks
Measured: baseline, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startJun 2012
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: lack of the subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myungho Jeong, phD, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766505
- Sponsor's protocol ID
- m111HHF11F
- Status last verified
- Mar 2014
- First submitted
- 10 Jan 2013
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01766505
- Acronym / sponsor ID
- m111HHF11F
- Conditions
- Hypertension
- Keywords
- hypertension, heart failure, candesartan, losartan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of the subjects
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare efficacy and safety of candesartan and losartan in hypertension with heart failure.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Candemore tablet | Experimental | Drug: Candemore tabletCandemore tablet: candesartan cilexetil 8mg, 16mg, 32mg/tab, orally, 1 tablet once a day during 16 weeks |
| Cozzar tablet | Active comparator | Drug: Cozzar tabletCozzar tablet: Losartan potassium 50mg, 100mg/cap, orally, 1 capsule once a day during 16 weeks |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Candemore tabletCandemore tablet 8, 16, or 32mg/tab, per oral, a tablet once a day during 16 weeks. dosage is depends on the sitting blood pressure. | Drug | Candemore tablet |
| Cozzar tabletCozzar tablet: 8mg, 16mg, 32mg/tablet, per oral, a tablet a day during 16 weeks dosage depends on sitting blood pressure | Drug | Cozzar tablet |
Primary outcome
change from baseline average sitting DBP(diastolic blood pressure)at 16 weeks
Time frame: baseline, 16 weeks
9 secondary outcomes
change from baseline average sitting DBP(diastolic blood pressure)at 8 weeks
Time frame: baseline, 8 weeks
change from baseline average sitting SBP(systolic blood pressure)at 8 weeks
Time frame: baseline, 8 weeks
change from baseline average sitting SBP(systolic blood pressure)at 16 weeks
Time frame: baseline, 16 weeks
ratio of normalize from baseline blood pressure at 16 weeks
Time frame: baseline, 16 weeks
response ratio from baseline blood pressure at 16 weeks
Time frame: baseline, 16 weeks
change from baseline LVEF(left ventricular ejection fraction at 16 weeks
Time frame: baseline, 16 weeks
change from baseline LVEDD(left ventricular end-diastolic diameter)at 16 weeks
Time frame: baseline, 16 weeks
change from baseline LV(left ventricular) mass at 16 weeks
Time frame: baseline, 16 weeks
change from baseline PWV(pulse wave velocity) mass at 16 weeks
Time frame: baseline, 16 weeks
Results and safety
The study was stopped early (reason given: lack of the subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myungho Jeong, phD principal investigator
Chonnam National University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Candemore tablet and Cozzar tablet in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 9 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of the subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline average sitting DBP(diastolic blood pressure)at 16 weeks (time frame: baseline, 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2014.