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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

169

Phase

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

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

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)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Mean sitting Systolic Blood Pressure Time Frame: After 12 weeks of treatment	After 12 weeks of treatment

Secondary Outcome Measures

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

Chong Kun Dang Pharmaceutical

Investigators

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

January 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

September 4, 2012

First Submitted That Met QC Criteria

September 6, 2012

First Posted (Estimate)

September 11, 2012

Study Record Updates

Last Update Posted (Estimate)

September 24, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

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.

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Hypertension

Clinical Trials on Candemore tablet

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