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| Name | Class |
|---|---|
| Seoul National University Hospital | OTHER |
| The Catholic University of Korea | OTHER |
| Kangbuk Samsung Hospital | OTHER |
| Konkuk University Medical Center |
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The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan (BR-A-657•K) 60 mg~120 mg in patients with mild to moderate essential hypertension.
Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan (BR-A-657-K) 20mg ~ 480mg single dosing with healthy subjects, demonstrated that the Fimasartan(BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose.
A Randomized, Double-blind, Losartan-controlled, Parallel Group Comparison Dose Titration Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan (BR-A-657•K) 60mg~120mg in Patients with Mild to Moderate Essential Hypertension.
Approximately 480 patients will be enrolled over 12 months in 24 centers nationwide.
After 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 2 groups. Subjects will take test/control drug for 12 weeks of treatment period. And Extensin study have 12 weeks in treatment period.
If subjects take any antihypertensive medications before screening, the subjects will have 1 week of wash-out period.
If the hypertension is not controlled well, there is a possibility of dose titration.
Group I : Fimasartan group. Group II : Losartan group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Active Comparator | Losartan group |
|
| 1 | Active Comparator | Fimasartan 60mg, 120mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan | Drug | Fimasartan 60 ~ 120mg/po take one tablets once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic Blood Pressure Change | Value of DBP at 12 Weeks minus value of DBP at Baseline while in a sitting position | baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic Blood Pressure Change |
| baseline and 4 weeks, 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byung-Hee Oh, MD | Seoul National University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22381711 | Derived | Lee SE, Kim YJ, Lee HY, Yang HM, Park CG, Kim JJ, Kim SK, Rhee MY, Oh BH; Investigators. Efficacy and tolerability of fimasartan, a new angiotensin receptor blocker, compared with losartan (50/100 mg): a 12-week, phase III, multicenter, prospective, randomized, double-blind, parallel-group, dose escalation clinical trial with an optional 12-week extension phase in adult Korean patients with mild-to-moderate hypertension. Clin Ther. 2012 Mar;34(3):552-568, 568.e1-9. doi: 10.1016/j.clinthera.2012.01.024. Epub 2012 Mar 3. | |
| 21740078 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control: Losartan | Losartan group Losartan (Control): Losartan 50 mg ~ 100 mg/po, take one tablets once a day |
| FG001 | Test: Fimasartan | Fimasartan 60mg, 120mg Fimasartan: Fimasartan 60 ~ 120mg/po take one tablets once a day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study |
|
| |||||||||||||||||||||
| Extension Study |
|
As ITT group, these are subjects who have been randomly assigned and have at least one primary end point.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control: Losartan | Losartan group Losartan (Control): Losartan 50 mg ~ 100 mg/po, take one tablets once a day |
| BG001 | Test: Fimasartan | Fimasartan 60mg, 120mg Fimasartan: Fimasartan 60 ~ 120mg/po take one tablets once a day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Diastolic Blood Pressure Change | Value of DBP at 12 Weeks minus value of DBP at Baseline while in a sitting position | As ITT group, these are subjects who have been randomly assigned and have at least one primary end point. | Posted | Mean | Standard Deviation | mmHg | baseline and 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control: Losartan | Losartan group Losartan (Control): Losartan 50 mg ~ 100 mg/po, take one tablets once a day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Clinical Research | Boryung Pharmaceuticals | +82-2-708-8069 | rainbowleo@boryung.co.kr |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| OTHER |
| Konyang University Hospital | OTHER |
| Keimyung University | OTHER |
| Korea University | OTHER |
| Korea University Guro Hospital | OTHER |
| Dongguk University International Hospital | OTHER |
| Seoul National University Bundang Hospital | OTHER |
| Samsung Medical Center | OTHER |
| Asan Medical Center | OTHER |
| Severance Hospital | OTHER |
| Ajou University | OTHER |
| Wonju Severance Christian Hospital | OTHER |
| Yeungnam University Hospital | OTHER |
| Yonsei University | OTHER |
| Inha University Hospital | OTHER |
| Chonbuk National University Hospital | OTHER |
| Cheil General Hospital and Women's Healthcare Center | OTHER |
| Chungnam National University | OTHER |
| Chungbuk National University Hospital | OTHER |
| Hanyang University | OTHER |
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| Losartan (Control) | Drug | Losartan 50 mg ~ 100 mg/po, take one tablets once a day |
|
|
| Derived |
| Fimasartan. Am J Cardiovasc Drugs. 2011 Aug 1;11(4):249-52. doi: 10.2165/11533640-000000000-00000. |
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Diastolic Blood Pressure Change |
| As ITT group, these are subjects who have been randomly assigned and have at least one primary end point. | Posted | Mean | Standard Deviation | mmHg | baseline and 4 weeks, 8 weeks |
|
|
|
|
| 5 |
| 250 |
| 76 |
| 250 |
| EG001 | Test: Fimasartan | Fimasartan 60mg, 120mg Fimasartan: Fimasartan 60 ~ 120mg/po take one tablets once a day | 3 | 255 | 82 | 255 |
| Appendicitis | Infections and infestations | Systematic Assessment |
|
| coronary artery occlusion | Cardiac disorders | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Multiple fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | Non-systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | Non-systematic Assessment |
|
| Global amnesia | Nervous system disorders | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Palatal oedema | Gastrointestinal disorders | Non-systematic Assessment |
|
| Tongue discolouration | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | Non-systematic Assessment |
|
| Otitis media acute | Infections and infestations | Non-systematic Assessment |
|
| pharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pelvic deformity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Blood urine present | Investigations | Non-systematic Assessment |
|
| Glucose urine present | Investigations | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | Non-systematic Assessment |
|
| Low density lipoprotein increased | Investigations | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | Non-systematic Assessment |
|
| Spinal X-ray abnormal | Investigations | Non-systematic Assessment |
|
| Chest discomfort | General disorders | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Asthenia | General disorders | Non-systematic Assessment |
|
| Face oedema | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Urticaria localised | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Blepharospasm | Eye disorders | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | Non-systematic Assessment |
|
| Eyelid ptosis | Eye disorders | Non-systematic Assessment |
|
| Keratoconjunctivitis sicca | Eye disorders | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | Non-systematic Assessment |
|
| Xerophthalmia | Eye disorders | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Flushing | Vascular disorders | Non-systematic Assessment |
|
| Eustachian tube dysfunction | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Hepatitis alcoholic | Hepatobiliary disorders | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | Non-systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |