To Evaluate the Efficacy and Safety on Blood Pressure In Patients With Hypertension Diagnosed Congestive Heart Failure (CANTABILE)
This study is currently recruiting participants.
Verified September 2012 by Chong Kun Dang Pharmaceutical
Sponsor:
Chong Kun Dang Pharmaceutical
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01682564
First received: September 4, 2012
Last updated: September 6, 2012
Last verified: September 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Congestive Heart Failure |
Drug: Candemore tablet Drug: Atacand tablet |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Chong Kun Dang Pharmaceutical:
Primary Outcome Measures:
- Mean sitting Systolic Blood Pressure [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean Sitting Diastolic Blood Pressure [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
- echocardiography [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]Left Ventricle Volume, Left Ventricle Ejection Fraction, E/E' ration, Peak TR velocity
- Blood Creatinine and Potssium level [ Time Frame: After 4 and 12 weeks of treatment ] [ Designated as safety issue: Yes ]
- NYHA class [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Candemore tablet
Candemore tablet
|
Drug: Candemore tablet
Other Name: Candemore tablet
|
|
Active Comparator: Atacand tablet
Atacand tablet
|
Drug: Atacand tablet
Other Name: Atacand tablet
|
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.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682564
Contacts
| Contact: KeeSik Kim, M.D Ph.D. | +82-53-650-3010 | kks7379@cu.ac.kr |
Locations
| Korea, Republic of | |
| Inje university pusan hospital | Recruiting |
| Busan, Busanjin-gu Gaegum-dong, Korea, Republic of, 614-735 | |
| Contact: Dong-Soo Kim, M.D Ph.D +82-51-890-6039 dongskim@inje.ac.kr | |
| Principal Investigator: Dong-Soo Kim, M.D Ph.D | |
| Gyeongsang national university hospital | Recruiting |
| Jinju, Chiram-dong, Korea, Republic of, 660-702 | |
| Contact: Choong Hwan Kwak, M.D +82-10-8503-9755 cwakch@naver.com | |
| Principal Investigator: Choong Hwan Kwak, M.D | |
| Daegu fatima hospital | Recruiting |
| Daegu, Dong-gu Sinam-dong, Korea, Republic of, 701-724 | |
| Contact: Byung-Chun Jung, M.D Ph.D +82-53-940-7293 augustjbc@yahoo.co.kr | |
| Principal Investigator: Byung-Chun Jung, M.D Ph.D | |
| Daedong hospital | Recruiting |
| Busan, Dongnae-gu Myeongnyun-dong, Korea, Republic of, 607-711 | |
| Contact: Byung Soo Kim, M.D Ph.D +82-51-741-5083 kbsmd@unitel.co.kr | |
| Principal Investigator: Byung Soo Kim, M.D Ph.D | |
| Inje university haeundae paik hospital | Recruiting |
| Busan, Haeundae-gu Heaundae-ro 875, Korea, Republic of, 612-030 | |
| Contact: Doo-il Kim, M.D Ph.D +82-51-797-3050 jo1216@chollian.net | |
| Principal Investigator: Doo-il Kim, M.D Ph.D | |
| Maryknoll medical center | Recruiting |
| Busan, Jung-gu Daecheong-dong, Korea, Republic of, 600-730 | |
| Contact: Tae Ik Kim, M.D +82-51-461-2429 kimti2429@gmail.com | |
| Principal Investigator: Tae Ik Kim, M.D | |
| Keimyung university dongsan medical center | Recruiting |
| Daegu, Jung-gu Dongsan-dong, Korea, Republic of, 700-712 | |
| Contact: Hyungseop Kim, M.D +82-10-9351-938 khyungseop@dsmc.or.kr | |
| Principal Investigator: Hungseop Kim, M.D | |
| Kyungpook national university hospital | Recruiting |
| Daegu, Jung-gu Samdeok-dong, Korea, Republic of, 700-721 | |
| Contact: Dong Hun Yang, M.D Ph.D +82-10-3005-7547 ddhyang@knu.ac.kr | |
| Principal Investigator: Dong Hun Yang, M.D Ph.D | |
| Samsung changwon hospital | Recruiting |
| Changwon, Masanhoiwon-gu Hapseong-dong 50, Korea, Republic of, 630-723 | |
| Contact: Juhyeon Oh, M.D Ph.D +82-55-290-6054 ojh@korea.com | |
| Principal Investigator: Juhyeon Oh, M.D Ph.D | |
| Yeungnam university medical center | Recruiting |
| Daegu, Nam-gu Daemyeong-dong, Korea, Republic of, 705-717 | |
| Contact: Dong Gu Shin, M.D Ph.D +82-10-4761-9123 dgshin@med.yu.ac.kr | |
| Principal Investigator: Dong Gu Shin, M.D Ph.D | |
| Daegu catholic univ. medical center | Recruiting |
| Daegu, Nam-gu Daemyung-dong, Korea, Republic of, 705-718 | |
| Contact: KeeSik Kim, M.D Ph.D +82-53-650-3010 kks7379@cu.ac.kr | |
| Principal Investigator: KeeSik Kim, M.D Ph.D | |
| Kosin university gospel hospital | Recruiting |
| Busan, Seo-gu Amnam-dong, Korea, Republic of, 602-702 | |
| Contact: Tae-joon Cha, M.D Ph.D +82-51-990-6725 chatjn@gmail.com | |
| Principal Investigator: Tae-joon Cha, M.D Ph.D | |
| Dong-A university medical center | Recruiting |
| Busan, Seo-gu Dongdaesin-dong, Korea, Republic of, 602-715 | |
| Contact: Tae Ho Park, M.D Ph.D +82-51-240-2964 thpark@dau.ac.kr | |
| Principal Investigator: Tae Ho Park, M.D Ph.D | |
| Dongguk university gyeongju hospital | Recruiting |
| Gyeongju, Seokjang-dong, Korea, Republic of, 780-350 | |
| Contact: Deuk-Young Nah, M.D +82-54-770-8561 ptca@dongguk.ac.kr | |
| Principal Investigator: Deuk-Young Nah, M.D | |
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
| Principal Investigator: | KeeSik Kim, M.D Ph.D | Daegu Catholic University Medical Center |
More Information
No publications provided
| Responsible Party: | Chong Kun Dang Pharmaceutical |
| ClinicalTrials.gov Identifier: | NCT01682564 History of Changes |
| Other Study ID Numbers: | m106CHF11E |
| Study First Received: | September 4, 2012 |
| Last Updated: | September 6, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Chong Kun Dang Pharmaceutical:
|
Candemore Atacand Candesartan cilexetil Primary Hypertension Congestive Hypertension |
Additional relevant MeSH terms:
|
Heart Failure Hypertension Heart Diseases Cardiovascular Diseases Vascular Diseases Candesartan cilexetil Candesartan |
Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013