Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-02-27 @ 1:08 AM
Study NCT ID:
NCT02944734
Status:
COMPLETED
Last Update Posted:
2016-11-22
First Post:
2016-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Efficacy and Safety of Combination Therapy and Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C077793', 'term': 'candesartan cilexetil'}, {'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 392}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-21', 'studyFirstSubmitDate': '2016-10-24', 'studyFirstSubmitQcDate': '2016-10-24', 'lastUpdatePostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change mean sitting Diastolic Blood Pressure (msDBP) at week 8 compared to baseline', 'timeFrame': 'Week 8'}], 'secondaryOutcomes': [{'measure': 'Change mean sitting Diastolic Blood Pressure (msDBP) at week 4 compared to baseline', 'timeFrame': 'Week 4'}, {'measure': 'Change mean sitting Systolic Blood Pressure (msSBP) at week 4 and 8 compared to baseline', 'timeFrame': 'Week 4 and 8'}, {'measure': 'Proportion of patients achieving treatment goal at week 4 and 8: < 140/90 mmHg', 'timeFrame': 'Week 4 and 8', 'description': 'Joint National Committee VII Guideline Treatment goal: \\< 140/90 mmHg (\\< 130/80 mmHg, diabetic or chronic renal failure patient)'}, {'measure': 'Blood Pressure Response rate at week 4 and 8: msSBP reduction ≥ 20 mmHg and msDBP reduction ≥ 10 mmHg', 'timeFrame': 'Week 4 and 8'}]}, 'conditionsModule': {'keywords': ['Candesartan', 'Amlodipine', 'Hypertension', 'Vascular Diseases', 'Cardiovascular Diseases', 'Antihypertensive Agents', 'Vasodilator Agents', 'Angiotensin II Type 1 Receptor Blockers', 'Angiotensin Receptor Antagonists', 'Calcium Channel Blockers'], 'conditions': ['Essential Hypertension']}, 'referencesModule': {'references': [{'pmid': '28734660', 'type': 'DERIVED', 'citation': 'Sohn IS, Kim CJ, Ahn T, Youn HJ, Jeon HK, Ihm SH, Cho EJ, Chung WB, Chae SC, Kim WS, Nam CW, Park SM, Choi JY, Kim YK, Hong TJ, Lee HY, Cho JH, Shin ES, Yoon JH, Yang TH, Jeong MH, Lee JH, Park JI. Efficacy and Tolerability of Combination Therapy Versus Monotherapy with Candesartan and/or Amlodipine for Dose Finding in Essential Hypertension: A Phase II Multicenter, Randomized, Double-blind Clinical Trial. Clin Ther. 2017 Aug;39(8):1628-1638. doi: 10.1016/j.clinthera.2017.06.014. Epub 2017 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the optimal dose of fixed-dose combination of candesartan cilexetil and amlodipine besylate by examining the safety and efficacy of the combination therapy compared to each of the monotherapy in patients with essential hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female patients greater than or equal to 19 years of age\n2. Subject who was diagnosed with essential hypertension or after administer the antihypertensive drug (Subject who may temporarily suspend antihypertensive treatment based on doctor's decision)\n3. Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form\n\nExclusion Criteria:\n\n1. Subject with severe hypertension (in a selected arm with msSBP ≥ 200 mmHg or msDBP ≥ 115 mmHg) during the Screening and Randomized Trial.\n2. Subject with difference of the blood pressure of over 20 mmHg for SBP or 10 mmHg for diastolic blood pressure (DSP) between three consecutive measurements in a selected arm during the screening visit\n3. Secondary hypertension (such as, coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.)\n4. Symptomatic orthostatic hypotension\n5. Severe heart failure( New York Heart Association(NYHA) Class III/IV)\n6. Subject with acute coronary syndrome(myocardial infarction or unstable angina), peripheral vascular disease within the past 6 months\n7. History of switching to another Antiarrhythmic drugs(not including electrolyte correction), or received Cardioversion or ICU treatment within the past 6 months\n8. Type 1 diabetes mellitus or Uncontrolled Type 2 diabetes mellitus (HbA1c \\> 9.0%)\n9. Subject with Haemodynamic disturbance, heart valve disease with structural defects\n10. Severe cerebrovascular disease (stroke, cerebral infarction, or cerebral hemorrhage, etc. within the past 6 months)\n11. Severe eye disease (retinal hemorrhage, visual impairment, retinal microaneurysm, etc. within the past 6 months)\n12. Autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)\n13. Chronic inflammatory disease requiring continuous anti-inflammatory treatment\n14. Clinically significant Renal or liver impairment, or laboratory abnormalities such as Ccr: below 30ml/min or Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \\> 3 x Upper Limit Normal (ULN)\n15. Hypokalaemia(Serum potassium \\< 3.5 mmol/L) or hyperkalaemia(Serum potassium \\> 5.5 mmol/L)\n16. Subject with gastrointestinal disease(such as Crohn's disease, gastric ulcer, acute or chronic pancreatitis) or history of gastrointestinal surgery(not including appendectomy or hernia surgery) that might significantly alter the absorption of the drug\n17. history of allergy or hypersensitivity to Angiotensin II Receptor Blockers(Candesartan) or Calcium Channel Blocker(amlodipine)\n18. Subject with heredity defects such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption\n19. Subject requiring concomitant use of other antihypertensive or contraindicated drugs( Tizanidine, dolasetron, Itraconazole, potassium, potassium-sparing diuretics, etc.) during the clinical trial\n20. history of malignant tumors within the past 5 years\n21. history of alcohol or drug abuse\n22. Pregnant women and lactating mothers\n23. Women who is planning to be pregnant during or 2 months after the study, or women or men who are not using medically acceptable methods of contraception \\*\n\n \\* progestin oral or implant contraceptive, intra-uterine device, condom, partner with surgical sterilization, etc.\n24. Use of other investigational products within the past 1 month\n25. Subject who are judged by the investigator unsuitable to participate in the study"}, 'identificationModule': {'nctId': 'NCT02944734', 'briefTitle': 'Comparison of Efficacy and Safety of Combination Therapy and Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shin Poong Pharmaceutical Co. Ltd.'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy vs. Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension', 'orgStudyIdInfo': {'id': 'SP-AC-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Candesartan Cilexetil (CC) 8mg', 'description': 'Candesartan Cilexetil 8mg, once a day for 8 weeks', 'interventionNames': ['Drug: Candesartan Cilexetil 8mg']}, {'type': 'EXPERIMENTAL', 'label': 'CC 16mg', 'description': 'Candesartan Cilexetil 16mg, once a day for 8 weeks', 'interventionNames': ['Drug: Candesartan Cilexetil 16mg']}, {'type': 'EXPERIMENTAL', 'label': 'Amlodipine(AML) 5mg', 'description': 'Amlodipine 5mg, once a day for 8 weeks', 'interventionNames': ['Drug: Amlodipine 5mg']}, {'type': 'EXPERIMENTAL', 'label': 'AML 10mg', 'description': 'Amlodipine 10mg, once a day for 8 weeks', 'interventionNames': ['Drug: Amlodipine 10mg']}, {'type': 'EXPERIMENTAL', 'label': 'CC 8mg / AML 5mg', 'description': 'Candesartan 8mg and Amlodipine 5mg, once a day for 8 weeks', 'interventionNames': ['Drug: Candesartan Cilexetil 8mg', 'Drug: Amlodipine 5mg']}, {'type': 'EXPERIMENTAL', 'label': 'CC 8mg / AML 10mg', 'description': 'Candesartan 8mg and Amlodipine 10mg, once a day for 8 weeks', 'interventionNames': ['Drug: Candesartan Cilexetil 8mg', 'Drug: Amlodipine 10mg']}, {'type': 'EXPERIMENTAL', 'label': 'CC 16mg / AML 5mg', 'description': 'Candesartan 16mg and Amlodipine 5mg, once a day for 8 weeks', 'interventionNames': ['Drug: Candesartan Cilexetil 16mg', 'Drug: Amlodipine 5mg']}, {'type': 'EXPERIMENTAL', 'label': 'CC 16mg / AML 10mg', 'description': 'Candesartan 16mg and Amlodipine 10mg, once a day for 8 weeks', 'interventionNames': ['Drug: Candesartan Cilexetil 16mg', 'Drug: Amlodipine 10mg']}], 'interventions': [{'name': 'Candesartan Cilexetil 8mg', 'type': 'DRUG', 'otherNames': ['Atacand 8mg'], 'description': 'Candesartan Cilexetil 8mg Daily oral administration for 8 weeks', 'armGroupLabels': ['CC 8mg / AML 10mg', 'CC 8mg / AML 5mg', 'Candesartan Cilexetil (CC) 8mg']}, {'name': 'Candesartan Cilexetil 16mg', 'type': 'DRUG', 'otherNames': ['Atacand 16mg'], 'description': 'Candesartan Cilexetil 16mg Daily oral administration for 8 weeks', 'armGroupLabels': ['CC 16mg', 'CC 16mg / AML 10mg', 'CC 16mg / AML 5mg']}, {'name': 'Amlodipine 5mg', 'type': 'DRUG', 'otherNames': ['Norvasc 5mg'], 'description': 'Amlodipine 5mg Daily oral administration for 8 weeks', 'armGroupLabels': ['Amlodipine(AML) 5mg', 'CC 16mg / AML 5mg', 'CC 8mg / AML 5mg']}, {'name': 'Amlodipine 10mg', 'type': 'DRUG', 'otherNames': ['Norvasc 10mg'], 'description': 'Amlodipine 10mg Daily oral administration for 8 weeks', 'armGroupLabels': ['AML 10mg', 'CC 16mg / AML 10mg', 'CC 8mg / AML 10mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wonmi-gu', 'state': 'Bucheon', 'country': 'South Korea', 'facility': "Catholic University of Korea Bucheon St. Mary's Hospital", 'geoPoint': {'lat': 37.5075, 'lon': 126.74583}}, {'city': 'Busanjin-gu', 'state': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Busan Paik Hospital'}, {'city': 'Seo-gu', 'state': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital'}, {'city': 'Joong-gu', 'state': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Medical Center'}, {'city': 'Joong-gu', 'state': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital'}, {'city': 'Nam- Gu', 'state': 'Daegu', 'country': 'South Korea', 'facility': 'Daegu Catholic University Medical Center'}, {'city': 'Wŏnju', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'city': 'Ilsandong-gu', 'state': 'Goyang-si, Gyeoggi-do', 'country': 'South Korea', 'facility': 'Dongguk University Ilsan Hospital'}, {'city': 'Dong-Gu', 'state': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital'}, {'city': 'Uijeongbu-si', 'state': 'Gyeoggi-do', 'country': 'South Korea', 'facility': "Catholic University of Korea Uijeongbu St. Mary's hospital", 'geoPoint': {'lat': 37.7415, 'lon': 127.0474}}, {'city': 'Namdong-gu', 'state': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Hospital'}, {'city': 'Suncheon-si', 'state': 'Jeollanam-do', 'country': 'South Korea', 'facility': 'St. Carollo General Hospital'}, {'city': 'Dongdaemun-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': "Catholic University of Korea St. Paul's Hospital"}, {'city': 'Dongdaemun-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'KyungHee University Medical Center'}, {'city': 'Gangdong-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Hallym University Kangdong Sacred Heart Hospital'}, {'city': 'Gangdong-Gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Hospital at Gangdong'}, {'city': 'Gangdong-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'VHS( Veterans Medical Service) Medical Center'}, {'city': 'Gwangjin-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center'}, {'city': 'Jongro-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital'}, {'city': 'Seocho-Gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': "Catholic University of Korea Seoul St. Mary's Hospital"}, {'city': 'Seongbuk-Gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital'}, {'city': 'Yeongdeungpo-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': "Catholic University of Korea Yeouido St. Mary's Hospital", 'geoPoint': {'lat': 37.51528, 'lon': 126.88722}}, {'city': 'Dong-gu', 'state': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital'}], 'overallOfficials': [{'name': 'Chong-Jin Kim', 'role': 'STUDY_DIRECTOR', 'affiliation': 'KyungHee University Hospital at Gangdong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shin Poong Pharmaceutical Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}