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Fimasartan/Amlodipine Combination Phase III

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fimasartan and Amlodipine
Fimasartan
Sponsored by
Boryung Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Fimasartan, Fimasartan and Amlodipine, Antihypertension

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fimasartan and Amlodipine

Fimasartan

Arm Description

Combination of Fimasartan and Amlodipine

Fimasartan Monotherapy

Outcomes

Primary Outcome Measures

Change of Sitting Systolic Blood Pressure(SiSBP) at week 8 of Investigational Product(IP) Administration from the Baseline
To compare the difference of Mean Systolic Blood Pressure at 8 weeks from baseline visit

Secondary Outcome Measures

Change of Sitting Systolic Blood Pressure(SiSBP) at week 4 of Investigational Product(IP) Administration from the Baseline
Changes of Sitting Diastolic Blood Pressure(SiDBP) at week 4 and 8 of Investigational Product(IP) Administration from the Baseline
Response rate of the Blood Pressure at week 8 of Investigational Product(IP) Administration
The Normalization ratio of Blood Pressure at week 8 of Investigational Product(IP) Administration

Full Information

First Posted
May 29, 2014
Last Updated
July 24, 2015
Sponsor
Boryung Pharmaceutical Co., Ltd
Collaborators
Gachon University Gil Medical Center, The Catholic University of Korea, Kangbuk Samsung Hospital, Kyungpook National University Hospital, 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
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1. Study Identification

Unique Protocol Identification Number
NCT02152306
Brief Title
Fimasartan/Amlodipine Combination Phase III
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 Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boryung Pharmaceutical Co., Ltd
Collaborators
Gachon University Gil Medical Center, The Catholic University of Korea, Kangbuk Samsung Hospital, Kyungpook National University Hospital, 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Fimasartan, Fimasartan and Amlodipine, Antihypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fimasartan and Amlodipine
Arm Type
Experimental
Arm Description
Combination of Fimasartan and Amlodipine
Arm Title
Fimasartan
Arm Type
Active Comparator
Arm Description
Fimasartan Monotherapy
Intervention Type
Drug
Intervention Name(s)
Fimasartan and Amlodipine
Intervention Type
Drug
Intervention Name(s)
Fimasartan
Primary Outcome Measure Information:
Title
Change of Sitting Systolic Blood Pressure(SiSBP) at week 8 of Investigational Product(IP) Administration from the Baseline
Description
To compare the difference of Mean Systolic Blood Pressure at 8 weeks from baseline visit
Time Frame
8 weeks from Baseline Visit
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Response rate of the Blood Pressure at week 8 of Investigational Product(IP) Administration
Time Frame
8 weeks from Baseline Visit
Title
The Normalization ratio of Blood Pressure at week 8 of Investigational Product(IP) Administration
Time Frame
8 weeks from Baseline Visit
Other Pre-specified Outcome Measures:
Title
Adverse Events
Time Frame
12 weeks from Screening Visit
Title
Adverse Changes in Laboratory Test Results
Time Frame
12 weeks from Screening Visit
Title
Adverse Changes in Electrocardiography (ECG)
Time Frame
12 weeks from Screening Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who voluntarily signed informed consent for participating in this clinical trial Male and Female between 20 and 75 years old Patients with essential hypertension 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) Understand the trial procedures and be willing to cooperate and complete the trial. Exclusion Criteria: Severe Hypertension patients (SiDBP ≥ 110mmHg and/or SiSBP ≥ 180mmHg) Subjects with the difference between blood pressures from a selected arm, SiDBP ≥10 mmHg or SiSBP ≥20 mmHg, at screening assessment 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.) 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 Clinically significant Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L) 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 Subjects with depletion of body fluid or sodium ion not able to correct 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) 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. Subjects with clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or any other clinical significant arrhythmia conditions at discretion of investigator. Subjects with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve stenosis, or mitral valve stenosis. Subjects with severe cerebrovascular disorder (e.g. stroke, cerebral infarction or cerebral hemorrhage within the past 6 months). 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. Subjects with known moderate or malignant retinosis (e.g. retinal hemorrhage, visual disturbance or retinal microaneurysm in the past 6 months). Subjects with hepatitis B (including positive test for HBsAg), hepatitis C-positive. Subjects with history or evidence of abusing drugs or alcohol within the past 2 years. Medical history with hypersensitivity to angiotensin II antagonist-based drugs or calcium-channel blockers Subjects with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption Pregnant women and lactating female 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. Subject who is participating in another trial or took other investigational product within12 weeks from the screening visit Medical history of all kinds of malignant tumor including leukemia and lymphoma in the past 5 years A subject with other reasons not specified above that, ineligible to participate in this clinical trial at discretion of study investigators.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheol Ho Kim, Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Bundang
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27502326
Citation
Kim KI, Shin MS, Ihm SH, Youn HJ, Sung KC, Chae SC, Nam CW, Seo HS, Park SM, Rhee MY, Kim MH, Cha KS, Kim YJ, Kim JJ, Chun KJ, Yoo BS, Park S, Shin ES, Kim DS, Il Kim D, Kim KH, Joo SJ, Jeong JO, Shin J, Kim CH. A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Fimasartan/Amlodipine Combined Therapy Versus Fimasartan Monotherapy in Patients With Essential Hypertension Unresponsive to Fimasartan Monotherapy. Clin Ther. 2016 Oct;38(10):2159-2170. doi: 10.1016/j.clinthera.2016.07.008. Epub 2016 Aug 5.
Results Reference
derived

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Fimasartan/Amlodipine Combination Phase III

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