Fimasartan/Amlodipine Combination Phase III

NCT02152306 | Completed Phase 3 DMC

• 1 other identifier: BR-FAC-CT-301
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Hypertension

Keywords

Fimasartan; Fimasartan and Amlodipine; Antihypertension

Outcome Measures

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

  8 weeks from Baseline Visit

Secondary Outcomes (4)

• Change of Sitting Systolic Blood Pressure(SiSBP) at week 4 of Investigational Product(IP) Administration from the Baseline

  4 weeks from Baseline Visit

• Changes of Sitting Diastolic Blood Pressure(SiDBP) at week 4 and 8 of Investigational Product(IP) Administration from the Baseline

  4 and 8 weeks from Baseline Visit

• Response rate of the Blood Pressure at week 8 of Investigational Product(IP) Administration

  8 weeks from Baseline Visit

• The Normalization ratio of Blood Pressure at week 8 of Investigational Product(IP) Administration

  8 weeks from Baseline Visit

Other Outcomes (3)

• Adverse Events

  12 weeks from Screening Visit

• Adverse Changes in Laboratory Test Results

  12 weeks from Screening Visit

• Adverse Changes in Electrocardiography (ECG)

  12 weeks from Screening Visit

Study Arms (2)

Fimasartan and Amlodipine

EXPERIMENTAL

Combination of Fimasartan and Amlodipine

Drug: Fimasartan and Amlodipine

Fimasartan

ACTIVE COMPARATOR

Fimasartan Monotherapy

Drug: Fimasartan

Interventions

Fimasartan and Amlodipine DRUG

Fimasartan and Amlodipine

Fimasartan DRUG

Fimasartan

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead
• Gachon University Gil Medical Center: collaborator
• The Catholic University of Korea: collaborator
• Kangbuk Samsung Hospital: collaborator
• Kyungpook National University Hospital: collaborator
• Keimyung University Dongsan Medical Center: collaborator
• Korea University Guro Hospital: collaborator
• Korea University Anam Hospital: collaborator
• DongGuk University: collaborator
• Dong-A University Hospital: collaborator
• Pusan National University Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator
• Seoul National University Hospital: collaborator
• Asan Medical Center: collaborator
• Pusan National University Yangsan Hospital: collaborator
• Wonju Severance Christian Hospital: collaborator
• Gangnam Severance Hospital: collaborator
• Severance Hospital: collaborator
• Ulsan University Hospital: collaborator
• Inje University: collaborator
• Inje University Haeundae Paik Hospital: collaborator
• Chonnam National University Hospital: collaborator
• Jeju National University Hospital: collaborator
• Chungnam National University: collaborator
• Hanyang University Seoul Hospital: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Bundang, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (1)

• 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.

  PMID: 27502326 DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

fimasartan; Amlodipine

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Cheol Ho Kim, Ph.D.

  Seoul National University Bundang Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 2, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 27, 2015

Record last verified: 2015-07

Locations

KR (1)