Comparison of Efficacy and Safety of Combination Therapy and Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension
NCT ID: NCT02944734
Last Updated: 2016-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
392 participants
INTERVENTIONAL
2014-09-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Candesartan Cilexetil (CC) 8mg
Candesartan Cilexetil 8mg, once a day for 8 weeks
Candesartan Cilexetil 8mg
Candesartan Cilexetil 8mg Daily oral administration for 8 weeks
CC 16mg
Candesartan Cilexetil 16mg, once a day for 8 weeks
Candesartan Cilexetil 16mg
Candesartan Cilexetil 16mg Daily oral administration for 8 weeks
Amlodipine(AML) 5mg
Amlodipine 5mg, once a day for 8 weeks
Amlodipine 5mg
Amlodipine 5mg Daily oral administration for 8 weeks
AML 10mg
Amlodipine 10mg, once a day for 8 weeks
Amlodipine 10mg
Amlodipine 10mg Daily oral administration for 8 weeks
CC 8mg / AML 5mg
Candesartan 8mg and Amlodipine 5mg, once a day for 8 weeks
Candesartan Cilexetil 8mg
Candesartan Cilexetil 8mg Daily oral administration for 8 weeks
Amlodipine 5mg
Amlodipine 5mg Daily oral administration for 8 weeks
CC 8mg / AML 10mg
Candesartan 8mg and Amlodipine 10mg, once a day for 8 weeks
Candesartan Cilexetil 8mg
Candesartan Cilexetil 8mg Daily oral administration for 8 weeks
Amlodipine 10mg
Amlodipine 10mg Daily oral administration for 8 weeks
CC 16mg / AML 5mg
Candesartan 16mg and Amlodipine 5mg, once a day for 8 weeks
Candesartan Cilexetil 16mg
Candesartan Cilexetil 16mg Daily oral administration for 8 weeks
Amlodipine 5mg
Amlodipine 5mg Daily oral administration for 8 weeks
CC 16mg / AML 10mg
Candesartan 16mg and Amlodipine 10mg, once a day for 8 weeks
Candesartan Cilexetil 16mg
Candesartan Cilexetil 16mg Daily oral administration for 8 weeks
Amlodipine 10mg
Amlodipine 10mg Daily oral administration for 8 weeks
Interventions
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Candesartan Cilexetil 8mg
Candesartan Cilexetil 8mg Daily oral administration for 8 weeks
Candesartan Cilexetil 16mg
Candesartan Cilexetil 16mg Daily oral administration for 8 weeks
Amlodipine 5mg
Amlodipine 5mg Daily oral administration for 8 weeks
Amlodipine 10mg
Amlodipine 10mg Daily oral administration for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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)
3. Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form
Exclusion Criteria
2. 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
3. Secondary hypertension (such as, coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.)
4. Symptomatic orthostatic hypotension
5. Severe heart failure( New York Heart Association(NYHA) Class III/IV)
6. Subject with acute coronary syndrome(myocardial infarction or unstable angina), peripheral vascular disease within the past 6 months
7. History of switching to another Antiarrhythmic drugs(not including electrolyte correction), or received Cardioversion or ICU treatment within the past 6 months
8. Type 1 diabetes mellitus or Uncontrolled Type 2 diabetes mellitus (HbA1c \> 9.0%)
9. Subject with Haemodynamic disturbance, heart valve disease with structural defects
10. Severe cerebrovascular disease (stroke, cerebral infarction, or cerebral hemorrhage, etc. within the past 6 months)
11. Severe eye disease (retinal hemorrhage, visual impairment, retinal microaneurysm, etc. within the past 6 months)
12. Autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
13. Chronic inflammatory disease requiring continuous anti-inflammatory treatment
14. 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)
15. Hypokalaemia(Serum potassium \< 3.5 mmol/L) or hyperkalaemia(Serum potassium \> 5.5 mmol/L)
16. 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
17. history of allergy or hypersensitivity to Angiotensin II Receptor Blockers(Candesartan) or Calcium Channel Blocker(amlodipine)
18. Subject with heredity defects such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
19. Subject requiring concomitant use of other antihypertensive or contraindicated drugs( Tizanidine, dolasetron, Itraconazole, potassium, potassium-sparing diuretics, etc.) during the clinical trial
20. history of malignant tumors within the past 5 years
21. history of alcohol or drug abuse
22. Pregnant women and lactating mothers
23. 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 \*
\* progestin oral or implant contraceptive, intra-uterine device, condom, partner with surgical sterilization, etc.
24. Use of other investigational products within the past 1 month
25. Subject who are judged by the investigator unsuitable to participate in the study
19 Years
ALL
No
Sponsors
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Shin Poong Pharmaceutical Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Chong-Jin Kim
Role: STUDY_DIRECTOR
KyungHee University Hospital at Gangdong
Locations
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Catholic University of Korea Bucheon St. Mary's Hospital
Wonmi-gu, Bucheon, South Korea
Inje University Busan Paik Hospital
Busanjin-gu, Busan, South Korea
Pusan National University Hospital
Seo-gu, Busan, South Korea
Keimyung University Dongsan Medical Center
Joong-gu, Daegu, South Korea
Kyungpook National University Hospital
Joong-gu, Daegu, South Korea
Daegu Catholic University Medical Center
Nam- Gu, Daegu, South Korea
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
Dongguk University Ilsan Hospital
Ilsandong-gu, Goyang-si, Gyeoggi-do, South Korea
Chonnam National University Hospital
Dong-Gu, Gwangju, South Korea
Catholic University of Korea Uijeongbu St. Mary's hospital
Uijeongbu-si, Gyeoggi-do, South Korea
Gachon University Gil Hospital
Namdong-gu, Incheon, South Korea
St. Carollo General Hospital
Suncheon-si, Jeollanam-do, South Korea
Catholic University of Korea St. Paul's Hospital
Dongdaemun-gu, Seoul, South Korea
KyungHee University Medical Center
Dongdaemun-gu, Seoul, South Korea
Hallym University Kangdong Sacred Heart Hospital
Gangdong-gu, Seoul, South Korea
Kyung Hee University Hospital at Gangdong
Gangdong-Gu, Seoul, South Korea
VHS( Veterans Medical Service) Medical Center
Gangdong-gu, Seoul, South Korea
Konkuk University Medical Center
Gwangjin-gu, Seoul, South Korea
Seoul National University Hospital
Jongro-gu, Seoul, South Korea
Catholic University of Korea Seoul St. Mary's Hospital
Seocho-Gu, Seoul, South Korea
Korea University Anam Hospital
Seongbuk-Gu, Seoul, South Korea
Catholic University of Korea Yeouido St. Mary's Hospital
Yeongdeungpo-gu, Seoul, South Korea
Ulsan University Hospital
Dong-gu, Ulsan, South Korea
Countries
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References
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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.
Other Identifiers
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SP-AC-002
Identifier Type: -
Identifier Source: org_study_id