Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-28 @ 4:19 PM
Study NCT ID:
NCT01838850
Status:
COMPLETED
Last Update Posted:
2018-12-24
First Post:
2013-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Combination Therapy in Patients With Hypertension Not Controlled With Olmesartan Medoxomil and Hydrochlorothiazide Combination Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068557', 'term': 'Olmesartan Medoxomil'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 344}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2013-04-22', 'studyFirstSubmitQcDate': '2013-04-22', 'lastUpdatePostDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Collection of safety data from Adverse event, Laboratory test, Physical examination, Vital signs with pulse and ECG', 'timeFrame': 'from screening to Week 16'}], 'primaryOutcomes': [{'measure': 'The changes of seated diastolic blood pressure of the Triple Combinations OM/AML/HCTZ 20/5/12.5mg vs.OM/HCTZ 20/12.5mg', 'timeFrame': 'from baseline to week 8'}], 'secondaryOutcomes': [{'measure': 'The changes of mean seated systolic blood pressure of the Triple Combinations OM/AML/HCTZ 20/5/12.5mg vs.OM/HCTZ 20/12.5mg', 'timeFrame': 'from baseline to Week 8'}, {'measure': 'The changes of mean seated systolic and diastolic blood pressure of the Triple Combinations OM/AML/HCTZ 20/5/12.5mg vs.OM/HCTZ 20/12.5mg', 'timeFrame': 'from baseline to week 4'}, {'measure': 'Percentage of subjects achieving blood pressure goal of the Triple Combinations OM/AML/HCTZ 20/5/12.5mg vs.OM/HCTZ 20/12.5mg', 'timeFrame': 'at Week 4, and Week 8'}, {'measure': 'Percentage of subjects achieving blood pressure goal of the Triple Combinations OM/AML/HCTZ 40/5/12.5mg vs.OM/AML/HCTZ 20/5/12.5mg', 'timeFrame': 'At week 16'}, {'measure': 'The changes of mean seated systolic and diastolic blood pressure of the Triple Combinations OM/AML/HCTZ 40/5/12.5mg vs.OM/AML/HCTZ 20/5/12.5mg', 'timeFrame': 'from Week 8 to Week 16'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Essential Hypertension']}, 'referencesModule': {'references': [{'pmid': '26691333', 'type': 'DERIVED', 'citation': 'Sohn IS, Kim CJ, Oh BH, Hong TJ, Park CG, Kim BS, Chung WB; Investigators. Efficacy and Safety Study of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Combination Therapy in Patients with Hypertension Not Controlled with Olmesartan Medoxomil and Hydrochlorothiazide Combination Therapy: Results of a Randomized, Double-Blind, Multicenter Trial. Am J Cardiovasc Drugs. 2016 Apr;16(2):129-38. doi: 10.1007/s40256-015-0156-x.'}]}, 'descriptionModule': {'briefSummary': 'CS-8635 combines three widely prescribed antihypertensive medications, olmesartan medoxomil(OM), amlodipine (AML), and hydrochlorothiazide (HCTZ), to lower blood pressure. The purpose of the study is to evaluate the efficacy and safety of triple therapy with CS-8635 compared with dual therapy in Korean patients with hypertension not controlled with dual fixed dose combination therapy (Olmetec® Plus). The treatments that will be used in this study are as follows: Run-in period -OM/HCTZ 20/12.5 mg (Olmetec® Plus 20/12.5 mg) ; Double blind treatment period - OM/AML/HCTZ 20/5/12.5mg (CS8635 20/5/12.5mg) + its matching placebo vs.OM/HCTZ 20/12.5mg (Olmetec® Plus 20/12.5 mg) + its matching placebo; Open label extension period - OM/AML/HCTZ 40/5/12.5mg (CS8635 40/5/12.5mg) or OM/AML/HCTZ 20/5/12.5mg (CS8635 20/5/12.5mg).', 'detailedDescription': 'Please refer to arms, outcome measures and eligibility criteria for details.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria for Screening\n\n* Male or female at the age of 20 to 75 years\n* Voluntary written informed consent to participation in this study\n* Patients with hypertension either newly diagnosed or without treatment of antihypertensive drugs within 4 weeks of screening, who have mean seated diastolic blood pressure (msDBP) ≥ 100 mmHg at screening, or\n* Patients who have been on a stable dose of antihypertensive drugs for at least 4 weeks before run-in period and meet the following blood pressure criteria at screening: Monotherapy: msDBP ≥ 95 mmHg, or Dual combination therapy: msDBP ≥ 90 mmHg, or Triple combination therapy: 70 mmHg ≤ msDBP \\< 90 mmHg\n\nInclusion criteria for randomization\n\n* msSBP/DBP at randomization: msSBP ≥ 140 mmHg (msSBP ≥ 130 mmHg in subjects with diabetes or chronic renal disease), and msDBP ≥ 90 mmHg (msDBP ≥ 80 mmHg in subjects with diabetes or chronic renal disease)\n\nExclusion Criteria:\n\n* msDBP ≥ 115mmHg or msSBP ≥ 200 mmHg measured at screening and randomization\n* Patients with mini-max blood pressure difference of SeSBP ≥ 20 mmHg or SeDBP ≥ 10 mmHg in the chosen arm at screening\n* Patients with blood pressure difference of SeSBP ≥ 20 mmHg and SeDBP ≥ 10 mmHg in both arms at screening\n* Patients with hypersensitivity to the investigational product or any of its components\n* Patients with medical history or hypersensitivity to sulfonamide, dihydropyridine, or thiazide diuretics\n* History of secondary hypertension or history of any of the diseases suspected of secondary hypertension\n* Symptomatic orthostatic hypotension\n* Uncontrolled diabetes mellitus\n* Severe heart disease, or ischemic heart disease, peripheral vascular disease\n* Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmia considered clinically significant\n* Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant stenosis on aortic valve or mitral valve.\n* Severe cerebrovascular disorder\n* Known moderate or malignant retinopathy\n* Consumption disease , autoimmune disease, or connective tissue disease\n* Patients requiring chronic anti-inflammatory treatment\n* Anuria or severe renal failure\n* Severe hepatic failure, AST or ALT \\> 3 times the upper limit of normal, biliary obstruction, biliary cirrhosis, or cholestasis\n* Patients who have been treated for hyponatremia, hypokalemia, hyperkalemia, hypercalcemia, or symptomatic hyperuricemia\n* Addison's disease\n* Glucose-galactose malabsorption, galactose intolerance, or Lapp lactase deficiency\n* Gastrointestinal tract disease or surgical operation that may affect absorption, distribution, metabolism, and excretion of drugs, presence of active gastritis or gastrointestinal/rectal bleeding considered clinical significant by the investigator, active inflammatory bowel syndrome within the last 12 months, etc\n* Patients with history of or suspected of drug or alcohol abuse\n* Pregnant or lactating women, or women of childbearing potential who do not agree to use appropriate contraceptive methods such as progestin hormone therapy (Oral, implant), intrauterine device, barrier methods of contraception (condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide), male sterilisation or true abstinence\n* Patients who participated in other clinical study within 1 month prior to screening\n* Patients considered to be incapable of complying with the protocol"}, 'identificationModule': {'nctId': 'NCT01838850', 'briefTitle': 'Efficacy and Safety Study of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Combination Therapy in Patients With Hypertension Not Controlled With Olmesartan Medoxomil and Hydrochlorothiazide Combination Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Triple Fixed Dose Combination Therapy With Olmesartan Medoxomil 20mg, Amlodipine 5mg and Hydrochlorothiazide 12.5mg in Patients With Hypertension Not Controlled With Dual Fixed Dose Combination Therapy With Olmesartan Medoxomil 20mg and Hydrochlorothiazide 12.5mg', 'orgStudyIdInfo': {'id': 'CS8635-SIT-11-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CS8635 20/5/12.5mg and placebo', 'description': 'Participants receiving Olmetec® Plus 20/12.5mg (OM/HCTZ 20/12.5 mg) for the 4-week, Run-in Period but who do not meet their blood pressure goals(Non-responders) could start receiving this triple fixed dose combination therapy (CS8635 20/5/12.5mg (OM/AML/HCTZ 20/5/12.5mg) + placebo) in randomized, 8-week, double-blind Period. The non-responders finishing double-blind treatment could continue the 8-week Open-label Period with CS8635 40/5/12.5mg (OM/AML/HCTZ 40/5/12.5 mg).', 'interventionNames': ['Drug: CS8635 20/5/12.5mg and placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Olmetec® Plus 20/12.5mg and placebo', 'description': 'Participants receiving Olmetec® Plus 20/12.5mg (OM/HCTZ 20/12.5 mg) for the 4-week, Run-in Period but who do not meet their blood pressure goals(Non-responders) could start receiving this dual fixed dose combination therapy (Olmetec® Plus 20/12.5mg (OM/HCTZ 20/12.5mg) + Placebo) in randomized, 8-week, double-blind Period. The non-responders finishing double-blind treatment could continue the 8-week Open-label Period with CS8635 20/5/12.5mg (OM/AML/HCTZ 20/5/12.5 mg).', 'interventionNames': ['Drug: Olmetec® Plus 20/12.5mg and placebo']}], 'interventions': [{'name': 'CS8635 20/5/12.5mg and placebo', 'type': 'DRUG', 'description': 'Run-in period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Hydrochlorothiazide(HCTZ) 20-12.5mg, given once a day.\n\nDouble-blind period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Amlodipine (AML)-Hydrochlorothiazide(HCTZ) 20-5-12.5mg, oral placebo tablet. All tablets are given once a day.\n\nOpen-label period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Amlodipine(AML)-Hydrochlorothiazide(HCTZ) 40-5-12.5mg, given once a day.', 'armGroupLabels': ['CS8635 20/5/12.5mg and placebo']}, {'name': 'Olmetec® Plus 20/12.5mg and placebo', 'type': 'DRUG', 'description': 'Run-in period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Hydrochlorothiazide(HCTZ) 20-12.5mg, given once a day.\n\nDouble-blind period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Hydrochlorothiazide(HCTZ) 20-12.5mg, oral placebo tablet. All tablets are given once a day.\n\nOpen-label period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Amlodipine(AML)-Hydrochlorothiazide(HCTZ) 20-5-12.5mg, given once a day.', 'armGroupLabels': ['Olmetec® Plus 20/12.5mg and placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '425-707', 'city': 'Ansan', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 36.8741, 'lon': 126.2116}}, {'zip': '431-796', 'city': 'Anyang', 'country': 'South Korea', 'facility': 'Hallym University Medical Center', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'zip': '420-767', 'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Soonchunhyang University Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '602-715', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '602-739', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '607-711', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Daedong Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '612-896', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Haeundae Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '614-735', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '361-711,', 'city': 'Cheongju-si', 'country': 'South Korea', 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'zip': '560-750', 'city': 'Cheonju', 'country': 'South Korea', 'facility': 'Presbyterian Medical Center', 'geoPoint': {'lat': 36.6536, 'lon': 128.61359}}, {'zip': '561-712', 'city': 'Cheonju', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 36.6536, 'lon': 128.61359}}, {'zip': '700-712', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '705-718', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Daegu Catholic University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '301-721', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '302-718', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Konyang University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '410-719', 'city': 'Goyang', 'country': 'South Korea', 'facility': 'Health Insurance Service Ilsan Hospital', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'zip': '471-701', 'city': 'Guri-si', 'country': 'South Korea', 'facility': 'Hanyang University Guri Hospital', 'geoPoint': {'lat': 37.5986, 'lon': 127.1394}}, {'zip': '501-757', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '405-835', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '463-707', 'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '130-702', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '134-727', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyunghee University Hospital at Gandong', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '134-791', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Veterans Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Sanmsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-720', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '136-705', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St. Mary's Hospital of the Catholic University of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '139-711', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eulji General Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '143-729', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '150-713', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Yeouido St. Mary's Hospital of the Catholic University of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '152-840', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '156-755', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '540-719', 'city': 'Suncheon', 'country': 'South Korea', 'facility': 'St. Carollo Hospital', 'geoPoint': {'lat': 34.9505, 'lon': 127.48784}}, {'zip': '443-380', 'city': 'Suwon', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '682-714', 'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'zip': '220-701', 'city': 'Wŏnju', 'country': 'South Korea', 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}], 'overallOfficials': [{'name': 'Chang-Wook Nam', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keimyung University Dongsan Medical Center'}, {'name': 'Cheol-Ho Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}, {'name': 'Sang-Hong Baek', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital of the Catholic University of Korea"}, {'name': 'Woo-Baek Chung', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Yeouido St. Mary's Hospital of the Catholic University of Korea"}, {'name': 'Woo-Shik Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyunghee University Medical Center'}, {'name': 'Tae-Hoon Ahn', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gachon University Gil Medical Center'}, {'name': 'Jang-Hyun Cho', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Carollo Hospital'}, {'name': 'Byung-Hee Oh', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National Univerisity Hospital'}, {'name': 'Hweung-Kon Hwang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konkuk University Medical Center'}, {'name': 'Chang-Gyu Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Guro Hospital'}, {'name': 'Eun-Seok Shin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ulsan University Hospital'}, {'name': 'Dong-Ju Choi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}, {'name': 'Joon-Han Shin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}, {'name': 'Myung-Ho Jeong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonnam National University Hospital'}, {'name': 'Jin-Ok Jeong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chungnam National University Hospital'}, {'name': 'Chong-Jin Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyunghee University Hospital at Gandong'}, {'name': 'Jang-Ho Bae', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konyang University Hospital'}, {'name': 'Seung-Hwan Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wonju Severance Christian Hospital'}, {'name': 'Se-Joong Rim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gangnam Severance Hospital'}, {'name': 'Jay-Young Rhew', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Presbyterian medical center'}, {'name': 'Doo-Il Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University'}, {'name': 'Dae-Kyeong Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University'}, {'name': 'Soon-Kil Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanyang University'}, {'name': 'Hye-Sun Seo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soonchunhyang University Hospital'}, {'name': 'Duk-Hyun Kang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}, {'name': 'Young-Dae Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dong-A University Hospital'}, {'name': 'Dong-Woon Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chungbuk National University Hospital'}, {'name': 'Taek-Jong Hong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pusan National University Hospital'}, {'name': 'Jong-Won Ha', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}, {'name': 'Woo-Jung Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hallym University Medical Center'}, {'name': 'Tae Ho Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine'}, {'name': 'Kee-Sik Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Daegu Catholic University Medical Center'}, {'name': 'Seung-Woo Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sanmsung Medical Center'}, {'name': 'Wan-Joo Shim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}, {'name': 'Joo-Young Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Health Insurance Service Ilsan Hospital'}, {'name': 'Jae-Woong Choi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eulji General Hospital'}, {'name': 'Sun-Hwa Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonbuk National University Hospital'}, {'name': 'Jeong-Cheon Ahn', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University'}, {'name': 'Keun Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul Veterans Hospital'}, {'name': 'Byung-Soo Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Daedong Hospital'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/daiichi-sankyo/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/', 'accessCriteria': "Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}