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A Randomized, Double-Blind, Placebo-Controlled, 3x3 Factorial Design, Phase II Study to Evaluate the Antihypertensive Efficacy and Safety of Combination of Fimasartan and Amlodipine in Patients With Essential Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Boryung Pharmaceutical Co., Ltd
Sponsor:
Collaborators:
Gachon University Gil Medical Center
The Catholic University of Korea
Gyungbook national university hospital
Daegu Catholic University Medical Center
Wonkwang university Hospital
Wonju Severance Christian Hospital
Korea University Guro Hospital
DongGuk University
Yeungnam University
Chonnam National University Hospital
Cheil General Hospital and Women’s Healthcare Center
Chungnam National University
Asan Medical Center
Seoul National University Bundang Hospital
Inha University Hospital
Seoul National University Hospital
Inje University
Samsung Medical Center
Busan university Yangsan Hospital
Soon Chun Hyang University
Catholic University of Korea St. Paul's Hospital
Hallym University Medical Center Kang-Dong
Jeju National University Hospital
Hanyang University Seoul Hoapital
Kangbuk Samsung Medical center
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01518998
First received: January 24, 2012
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan


Condition Intervention Phase
Hypertension
Drug: Fimasartan , Amlodipine, Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Boryung Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • Sitting Diastolic Blood Pressure [ Time Frame: 8weeks from baseline visit ] [ Designated as safety issue: Yes ]
    To compare the difference of Sitting Diastolic Blood Pressure at 8 weeks from baseline visit


Secondary Outcome Measures:
  • Sitting Systolic Blood Pressure [ Time Frame: at 4 and 8 weeks from Baseline visit ] [ Designated as safety issue: Yes ]
    To compare the difference of Sitting Systolic Blood Pressure at 4,8 weeks from baseline visit

  • Sitting Diastolic Blood Pressure [ Time Frame: 4weeks from baseline visit ] [ Designated as safety issue: Yes ]
    To compare the difference of Sitting Diastolic Blood Pressure at 4 weeks from baseline visit

  • Responder ratio [ Time Frame: at 8weeks from baseline visit ] [ Designated as safety issue: Yes ]
    To compare the ratio or responder(SiDBP<90mmHg or difference of SiDBP>10mmHg from baseline) at 8 weeks


Estimated Enrollment: 405
Study Start Date: August 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Take one double-blind capsule filled with a placebo tablet in the every morning
Drug: Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60/Amlodipine 5mg combination, Fimasartan 60/Amlodipine 10mg combination, Fimasartan 30/Amlodipine 5mg combination, Fimasartan 30/Amlodipine 10mg combination
Other Names:
  • Kanarb
  • Norvasc
Active Comparator: Fimasartan 60mg
Take one double-blind capsule filled with of Fimasartan 60mg in the every morning
Drug: Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60/Amlodipine 5mg combination, Fimasartan 60/Amlodipine 10mg combination, Fimasartan 30/Amlodipine 5mg combination, Fimasartan 30/Amlodipine 10mg combination
Other Names:
  • Kanarb
  • Norvasc
Active Comparator: Fimasartan 30mg
Take one double-blind capsule filled with Fimasartan 30mg in the every morning
Drug: Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60/Amlodipine 5mg combination, Fimasartan 60/Amlodipine 10mg combination, Fimasartan 30/Amlodipine 5mg combination, Fimasartan 30/Amlodipine 10mg combination
Other Names:
  • Kanarb
  • Norvasc
Active Comparator: Amlodipine 5mg
Take one double-blind capsule filled with Amlodipine 5mg in the every morning
Drug: Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60/Amlodipine 5mg combination, Fimasartan 60/Amlodipine 10mg combination, Fimasartan 30/Amlodipine 5mg combination, Fimasartan 30/Amlodipine 10mg combination
Other Names:
  • Kanarb
  • Norvasc
Active Comparator: Amlodipine 10mg
Take one double-blind capsule filled with Amlodipine 10mg in the every morning
Drug: Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60/Amlodipine 5mg combination, Fimasartan 60/Amlodipine 10mg combination, Fimasartan 30/Amlodipine 5mg combination, Fimasartan 30/Amlodipine 10mg combination
Other Names:
  • Kanarb
  • Norvasc
Experimental: Fimasartan 60/ Amlodipine 5mg
Take one double-blind capsule filled with Fimasartan 60mg and Amlodipine 5mg in the every morning
Drug: Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60/Amlodipine 5mg combination, Fimasartan 60/Amlodipine 10mg combination, Fimasartan 30/Amlodipine 5mg combination, Fimasartan 30/Amlodipine 10mg combination
Other Names:
  • Kanarb
  • Norvasc
Experimental: Fimasartan 60/Amlodipine 10mg
Take one double-blind capsule filled with Fimasartan 60mg and Amlodipine 10mg in the every morning
Drug: Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60/Amlodipine 5mg combination, Fimasartan 60/Amlodipine 10mg combination, Fimasartan 30/Amlodipine 5mg combination, Fimasartan 30/Amlodipine 10mg combination
Other Names:
  • Kanarb
  • Norvasc
Experimental: Fimasartan 30/Amlodipine 5mg
Take one double-blind capsule filled with Fimasartan 30mg and Amlodipine 5mg in the every morning
Drug: Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60/Amlodipine 5mg combination, Fimasartan 60/Amlodipine 10mg combination, Fimasartan 30/Amlodipine 5mg combination, Fimasartan 30/Amlodipine 10mg combination
Other Names:
  • Kanarb
  • Norvasc
Experimental: Fimasartan 30/Amlodipine 10mg
Take one double-blind capsule filled with Fimasartan 30mg and Amlodipine 10mg in the every morning
Drug: Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60/Amlodipine 5mg combination, Fimasartan 60/Amlodipine 10mg combination, Fimasartan 30/Amlodipine 5mg combination, Fimasartan 30/Amlodipine 10mg combination
Other Names:
  • Kanarb
  • Norvasc

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects who agreed to participate in this study and submitted the written informed consent
  2. Subjects aged 20 to 75 years
  3. Essential hypertension subjects who are measured more 90mmHg, less than 114mmHg of sitting diastolic blood pressure (SiDBP) at baseline(day 0).
  4. Subjects who considered to understand this study , be cooperative, and able to be followed-up whole of the study period.

Exclusion Criteria:

  1. Severe hypertension patients; more 115mmHg of SiDBP and/or more 185 mmHg of Sitting systolic blood pressure (SiSBP)
  2. Patients with secondary hypertension
  3. Patients with significant investigations - abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication
  4. Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
  5. Patients with sodium ion or body fluid is depleted and not able to correct
  6. Patients with hypotension who has sign and symptom
  7. Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion
  8. Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c > 9%, regimen change of oral hypoglycemic agent, using insulin)
  9. Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)
  10. Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
  11. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
  12. Patients with severe cerebrovascular disease
  13. Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous.
  14. Patients with known severe or malignancy retinopathy
  15. Patients with hepatitis B or C or HIV positive reaction
  16. Patients who have a story or evidence of alcohol or drug abuse within 2years
  17. Patients who are measured the mean difference of mean blood pressure of both arm under SiDBP 10mmHg or SiSBP 20mmHg at screening and baseline visit
  18. Patients with history of allergic reaction to any angiotensin II antagonist
  19. Patients with any chronic inflammation disease needed to chronic inflammation therapy
  20. Patients with the medical histories of malignant tumor within 5years, except local basal cell carcinoma of the skin
  21. Childbearing and breast-feeding women
  22. Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
  23. Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial
  24. Subject who are judged unsuitable to participate in this study by investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518998

Contacts
Contact: Sung Hee Lee, Manager 82-2-708-8069 shlee07@boryung.co.kr
Contact: Eun Jeong Jeon, Assitant manager 82-2-708-8062 eunj0408@boryung.co.kr

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Eun Seok Jeon    82-2-3410-0866    esjeon@smc.co.kr   
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Gachon University Gil Medical Center
The Catholic University of Korea
Gyungbook national university hospital
Daegu Catholic University Medical Center
Wonkwang university Hospital
Wonju Severance Christian Hospital
Korea University Guro Hospital
DongGuk University
Yeungnam University
Chonnam National University Hospital
Cheil General Hospital and Women’s Healthcare Center
Chungnam National University
Asan Medical Center
Seoul National University Bundang Hospital
Inha University Hospital
Seoul National University Hospital
Inje University
Samsung Medical Center
Busan university Yangsan Hospital
Soon Chun Hyang University
Catholic University of Korea St. Paul's Hospital
Hallym University Medical Center Kang-Dong
Jeju National University Hospital
Hanyang University Seoul Hoapital
Kangbuk Samsung Medical center
Investigators
Study Director: Young Kwan Jeon, Medical Director Boryung Pharmaceutical Co., Ltd
  More Information

No publications provided

Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01518998     History of Changes
Other Study ID Numbers: BR-FAC-CT-201
Study First Received: January 24, 2012
Last Updated: March 26, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Boryung Pharmaceutical Co., Ltd:
Fimasartan
Amlodipine
antihypertension

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014