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Fimasartan/Amlodipine Combination Phase III

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ClinicalTrials.gov Identifier: NCT02152306
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : July 27, 2015
Sponsor:
Collaborators:
Gachon University Gil Medical Center
The Catholic University of Korea
Kangbuk Samsung Hospital
Kyungpook National University
Keimyung University Dongsan Medical Center
Korea University Guro Hospital
Korea University Anam Hospital
DongGuk University
Dong-A University Hospital
Pusan National University Hospital
Seoul National University Bundang Hospital
Seoul National University Hospital
Asan Medical Center
Pusan National University Yangsan Hospital
Wonju Severance Christian Hospital
Gangnam Severance Hospital
Severance Hospital
Ulsan University Hospital
Inje University
Inje University Haeundai Paik Hospital
Chonnam National University Hospital
Jeju National University Hospital
Chungnam National University
Hanyang University Seoul Hospital
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd

Brief Summary:
The aim of this study is to ensure the superiority of Fimasartan/Amlodipine combination in hypotensive effect after 8 weeks of treatment over Fimasartan monotherapy in patients with hypertension who have no response to Fimasartan 60mg monotherapy.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: Fimasartan and Amlodipine Drug: Fimasartan Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination of Fimasartan/Amlodipine Versus Fimasartan Monotherapy in Patients With Essential Hypertension Who Fail to Respond Adequately to Fimasartan Monotherapy.
Study Start Date : April 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fimasartan and Amlodipine
Combination of Fimasartan and Amlodipine
Drug: Fimasartan and Amlodipine
Active Comparator: Fimasartan
Fimasartan Monotherapy
Drug: Fimasartan



Primary Outcome Measures :
  1. Change of Sitting Systolic Blood Pressure(SiSBP) at week 8 of Investigational Product(IP) Administration from the Baseline [ Time Frame: 8 weeks from Baseline Visit ]
    To compare the difference of Mean Systolic Blood Pressure at 8 weeks from baseline visit


Secondary Outcome Measures :
  1. Change of Sitting Systolic Blood Pressure(SiSBP) at week 4 of Investigational Product(IP) Administration from the Baseline [ Time Frame: 4 weeks from Baseline Visit ]
  2. Changes of Sitting Diastolic Blood Pressure(SiDBP) at week 4 and 8 of Investigational Product(IP) Administration from the Baseline [ Time Frame: 4 and 8 weeks from Baseline Visit ]
  3. Response rate of the Blood Pressure at week 8 of Investigational Product(IP) Administration [ Time Frame: 8 weeks from Baseline Visit ]
  4. The Normalization ratio of Blood Pressure at week 8 of Investigational Product(IP) Administration [ Time Frame: 8 weeks from Baseline Visit ]

Other Outcome Measures:
  1. Adverse Events [ Time Frame: 12 weeks from Screening Visit ]
  2. Adverse Changes in Laboratory Test Results [ Time Frame: 12 weeks from Screening Visit ]
  3. Adverse Changes in Electrocardiography (ECG) [ Time Frame: 12 weeks from Screening Visit ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects who voluntarily signed informed consent for participating in this clinical trial
  2. Male and Female between 20 and 75 years old
  3. Patients with essential hypertension
  4. Patients who is unresponsive to Fimasartan 60mg monotherapy for 4 weeks (i.e. the mean SiDBP from 3 times of measurement is 140mmHg ≤ SiSBP <180 mmHg)
  5. Understand the trial procedures and be willing to cooperate and complete the trial.

Exclusion Criteria:

  1. Severe Hypertension patients (SiDBP ≥ 110mmHg and/or SiSBP ≥ 180mmHg)
  2. Subjects with the difference between blood pressures from a selected arm, SiDBP ≥10 mmHg or SiSBP ≥20 mmHg, at screening assessment
  3. Secondary hypertension patients, but not limited to the following disease;(example: renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromo-cytoma, polycystic kidney disease, etc.)
  4. Clinically significant renal function abnormality in the laboratory results at screening (i.e. serum creatine ≥ 1.5 times upper normal limit (UNL)), liver function abnormality (ALT, AST ≥ 2 times upper normal limit (UNL)), severe fatty liver disease that requires medication
  5. Clinically significant Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
  6. Subjects with following surgical and internal disease that may affect absorption, distribution, metabolism or excretion of drugs and have conditions which include the following (but are not limited to): history of major gastrointestinal surgeries including gastrectomy, gastro-enterostomy or bowel resection, gastrointestinal bypass graft and stapling; current active gastritis, ulcer, gastrointestinal and rectal bleeding, presence of active inflammatory bowel syndrome within the past 12 months; or clinically significant urinary obstruction at discretion of investigator
  7. Subjects with depletion of body fluid or sodium ion not able to correct
  8. Subjects with severe insulin-dependent Diabetes Mellitus (DM) or chronic DM (HbA1c>9%, dosage of an oral hypoglycemic agent was modified within the past 12 weeks, or use of active insulin treatment at screening)
  9. Subjects with severe heart disease (heart failure New York Heart Association(NYHA) Class III and IV), or history of any of the followings within the past 6 months; ischemic heart disease(e.g. angina pectoris, myocardial infarction), peripheral vascular disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft.
  10. Subjects with clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or any other clinical significant arrhythmia conditions at discretion of investigator.
  11. Subjects with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve stenosis, or mitral valve stenosis.
  12. Subjects with severe cerebrovascular disorder (e.g. stroke, cerebral infarction or cerebral hemorrhage within the past 6 months).
  13. Subjects with chronic inflammatory disease requiring an chronic anti-inflammatory therapy, Past or current medical history with wasting disease, autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus ) or connective tissue disease.
  14. Subjects with known moderate or malignant retinosis (e.g. retinal hemorrhage, visual disturbance or retinal microaneurysm in the past 6 months).
  15. Subjects with hepatitis B (including positive test for HBsAg), hepatitis C-positive.
  16. Subjects with history or evidence of abusing drugs or alcohol within the past 2 years.
  17. Medical history with hypersensitivity to angiotensin II antagonist-based drugs or calcium-channel blockers
  18. Subjects with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  19. Pregnant women and lactating female
  20. Women of childbearing potential who are not using effective contraceptive methods. (Excluding subjects who had surgically sterilized. All women of childbearing potential who did not have surgical sterilization must prove negative in a pregnancy test, and continue to use accepted and effective contraceptive methods until the end of the study in order to participate. Not accepted contraceptive method: Periodic abstinence and celibacy (e.g. Basic body temperature method, menstrual cycle calculation), hormonal contraceptives.
  21. Subject who is participating in another trial or took other investigational product within12 weeks from the screening visit
  22. Medical history of all kinds of malignant tumor including leukemia and lymphoma in the past 5 years
  23. A subject with other reasons not specified above that, ineligible to participate in this clinical trial at discretion of study investigators.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152306


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Bundang, Gyeonggi, Korea, Republic of, 463-707
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Gachon University Gil Medical Center
The Catholic University of Korea
Kangbuk Samsung Hospital
Kyungpook National University
Keimyung University Dongsan Medical Center
Korea University Guro Hospital
Korea University Anam Hospital
DongGuk University
Dong-A University Hospital
Pusan National University Hospital
Seoul National University Bundang Hospital
Seoul National University Hospital
Asan Medical Center
Pusan National University Yangsan Hospital
Wonju Severance Christian Hospital
Gangnam Severance Hospital
Severance Hospital
Ulsan University Hospital
Inje University
Inje University Haeundai Paik Hospital
Chonnam National University Hospital
Jeju National University Hospital
Chungnam National University
Hanyang University Seoul Hospital
Investigators
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Study Chair: Cheol Ho Kim, Ph.D. Seoul National University Bundang Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT02152306     History of Changes
Other Study ID Numbers: BR-FAC-CT-301
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: July 2015
Keywords provided by Boryung Pharmaceutical Co., Ltd:
Fimasartan
Fimasartan and Amlodipine
Antihypertension
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents