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CompletedNCT02152306Updated Jul 27, 2015

Fimasartan/Amlodipine Combination Phase III

A Phase 3 interventional study of Fimasartan and Amlodipine and Fimasartan in Essential Hypertension, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-07-27.

Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
143
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Essential Hypertension

Keywords

  • Fimasartan
  • Fimasartan and Amlodipine
  • Antihypertension
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 143 is above the median of 90 across 4,994 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Boryung Pharmaceutical Co., Ltd is the lead sponsor of 139 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
143 participants (actual)

Study arms

  • Experimental
    Fimasartan and Amlodipine

    Combination of Fimasartan and Amlodipine

    Drug: Fimasartan and Amlodipine

  • Active comparator
    Fimasartan

    Fimasartan Monotherapy

    Drug: Fimasartan

Interventions

  • DrugFimasartan and Amlodipine
  • DrugFimasartan
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 8 weeks from Baseline Visit

Secondary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Bundang, Gyeonggi 463-707, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 27502326 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02152306
Lead 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 Haeundae Paik Hospital, Chonnam National University Hospital, Jeju National University Hospital, Chungnam National University, Hanyang University Seoul Hospital
Responsible party
Sponsor
First posted
Jun 2, 2014
Start date
Apr 2014
Primary completion
Mar 2015
Completion
Jul 2015
Last update
Jul 27, 2015

Study contacts

Cheol Ho Kim, Ph.D.
study chair · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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