To Evaluate the Efficacy and Safety on Blood Pressure In Patients With Hypertension Diagnosed Congestive Heart Failure (CANTABILE)

September 22, 2015 updated by: Chong Kun Dang Pharmaceutical

Open Label, Randomized, Active Drug Comparative, Parallel Group, Multi-center, Phase IV Study to Compare and Evaluate the Efficacy and Safety of Candemore Tab and Atacand Tab.

To compare and evaluate the efficacy and safety of Candemore tab. versus Atacand tab. on blood pressure in patients with hypertension diagnosed congestive heart failure

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open label, randomized, active drug comparative, Parallel group, Multi-center, phase IV study. Patients receive candemore tablet or atacand tablet. Initial dose is 4mg/day or 8mg/day. Every 2 weeks, patients take double dose if patients blood pressure is measured SBP ≥ 100mmHg and DBP > 60mmHg. Maximum dose is 16mg/day.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
169

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Busanjin-gu Gaegum-dong
      • Busan, Busanjin-gu Gaegum-dong, Korea, Republic of, 614-735
        • Inje University Pusan Hospital
    • Chiram-dong
      • Jinju, Chiram-dong, Korea, Republic of, 660-702
        • Gyeongsang National University Hospital
    • Dong-gu Sinam-dong
      • Daegu, Dong-gu Sinam-dong, Korea, Republic of, 701-724
        • Daegu Fatima Hospital
    • Dongnae-gu Myeongnyun-dong
      • Busan, Dongnae-gu Myeongnyun-dong, Korea, Republic of, 607-711
        • Daedong hospital
    • Haeundae-gu Heaundae-ro 875
      • Busan, Haeundae-gu Heaundae-ro 875, Korea, Republic of, 612-030
        • Inje university Haeundae Paik Hospital
    • Jung-gu Daecheong-dong
      • Busan, Jung-gu Daecheong-dong, Korea, Republic of, 600-730
        • Maryknoll Medical Center
    • Jung-gu Dongsan-dong
      • Daegu, Jung-gu Dongsan-dong, Korea, Republic of, 700-712
        • Keimyung University Dongsan Medical Center
    • Jung-gu Samdeok-dong
      • Daegu, Jung-gu Samdeok-dong, Korea, Republic of, 700-721
        • Kyungpook National University Hospital
    • Masanhoiwon-gu Hapseong-dong 50
      • Changwon, Masanhoiwon-gu Hapseong-dong 50, Korea, Republic of, 630-723
        • Samsung Changwon Hospital
    • Nam-gu Daemyeong-dong
      • Daegu, Nam-gu Daemyeong-dong, Korea, Republic of, 705-717
        • Yeungnam University Medical Center
    • Nam-gu Daemyung-dong
      • Daegu, Nam-gu Daemyung-dong, Korea, Republic of, 705-718
        • Daegu Catholic Univ. Medical Center
    • Seo-gu Amnam-dong
      • Busan, Seo-gu Amnam-dong, Korea, Republic of, 602-702
        • Kosin university gospel hospital
    • Seo-gu Dongdaesin-dong
      • Busan, Seo-gu Dongdaesin-dong, Korea, Republic of, 602-715
        • Dong-A University Medical Center
    • Seokjang-dong
      • Gyeongju, Seokjang-dong, Korea, Republic of, 780-350
        • Dongguk University Gyeongju Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • willing and able to provide written informed consent
  • age 20 years or older
  • patient with congestive heart failure, taking treatment medicine and NYHA grade II~III
  • patient with hypertension, taking treatment medicine or SBP ≥ 140mmHg or DBP ≥ 90mmHg at the screening visit

Exclusion Criteria:

  • Known or suspected secondary hypertension(ex. aortic coactation, primary hyperaldosteronism, renal artery stenosis, pheochromocytoma, cushing syndrome, polycystic renal disease)
  • blood creatinine level ≥ 2.5mg/dl
  • blood potassium level > 5.5mEq/L
  • blood SGOT, SGPT level ≥ maximum normal range X3 or patient with sever hepatic dysfunction, cholestasis
  • pregnant or breast-feeding
  • premenopausal women not using adequate contraception
  • patient has history about hypersensitivity or taboo of investigational product
  • patient with lactose intolerance or Lapp lactase deficiency or glucode-galactose malabsorption
  • administration of other study drugs within 1 month prior to screening
  • history of ischemic heart disease(ex. angina pectoris, myocardial infarction) within the last 3 months
  • in investigator's judgement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Candemore tablet

Candemore tablet

  • Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg
  • dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day)
Drug: Candemore tablet
  • Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg
  • dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day)
Active Comparator: Atacand tablet

Atacand tablet

  • Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg
  • dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day)
Drug: Atacand tablet
  • Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg
  • dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean sitting Systolic Blood Pressure
Time Frame: After 12 weeks of treatment
After 12 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Sitting Diastolic Blood Pressure
Time Frame: After 12 weeks of treatment
After 12 weeks of treatment
echocardiography
Time Frame: After 12 weeks of treatment
Left Ventricle Volume, Left Ventricle Ejection Fraction, E/E' ration, Peak TR velocity
After 12 weeks of treatment
Blood Creatinine and Potssium level
Time Frame: After 4 and 12 weeks of treatment
After 4 and 12 weeks of treatment
NYHA class
Time Frame: After 12 weeks of treatment
After 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chong Kun Dang Pharmaceutical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: KeeSik Kim, M.D Ph.D, Daegu Catholic University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • m106CHF11E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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