A Phase 2 Dose Selection Trial of Candesartan Cilexetil and Amlodipine Besylate to Treat Essential Hypertension
NCT ID: NCT02059616
Last Updated: 2014-04-30
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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UNKNOWN
PHASE2
384 participants
INTERVENTIONAL
2014-02-28
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AML 5mg
Amlodipine 5 mg, once a day for 8 weeks
Amlodipine 5mg
Daily oral administration for 8 weeks
AML 10mg
Amlodipine 10 mg, once a day for 8 weeks
Amlodipine 10mg
Daily oral administration for 8 weeks
CC 8mg
Candesartan Cilexetil 8 mg, once a day for 8 weeks
Candesartan Cilexetil 8mg
Daily oral administration for 8 weeks
CC 16mg
Candesartan Cilexetil 16 mg, once a day for 8 weeks
Candesartan cilexetil 16mg
Daily oral administration for 8 weeks
AML 5mg/CC 8mg
Amlodipine 5 mg and Candesartan 8 mg, once a day for 8 weeks
Amlodipine 5mg
Daily oral administration for 8 weeks
Candesartan Cilexetil 8mg
Daily oral administration for 8 weeks
AML 5mg/CC16mg
Amlodipine 5 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
Amlodipine 5mg
Daily oral administration for 8 weeks
Candesartan cilexetil 16mg
Daily oral administration for 8 weeks
AML 10mg/CC 8mg
Amlodipine 10 mg and Candesartan Cilexetil 8 mg, once a day for 8 weeks
Amlodipine 10mg
Daily oral administration for 8 weeks
Candesartan Cilexetil 8mg
Daily oral administration for 8 weeks
AML 10mg/CC 16mg
Amlodipine 10 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
Amlodipine 10mg
Daily oral administration for 8 weeks
Candesartan cilexetil 16mg
Daily oral administration for 8 weeks
Interventions
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Amlodipine 5mg
Daily oral administration for 8 weeks
Amlodipine 10mg
Daily oral administration for 8 weeks
Candesartan Cilexetil 8mg
Daily oral administration for 8 weeks
Candesartan cilexetil 16mg
Daily oral administration for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject with mild-to-moderate uncomplicated essential hypertension
* Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form, after having listened to the purpose, method, and effect of the clinical trial
Exclusion Criteria
* Subject with difference in the mean blood pressure of over 10mmHg for siDBP or 20mmHg for siSBP between both arms at the screening visit
* Subject with known or suspected secondary hypertension \[including but not limited to any of the following: renovascular hypertension, adrenal medullary and cortical hyperfunction, coarctation of the aorta, primary hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.\]
* Subject with symptomatic orthostatic hypotension (a sudden fall in siDBP of at least 10 mmHg or siSBP of at least 20 mmHg after standing compared with blood pressure from the sitting or supine position)
* Subject with Type 1 diabetes mellitus OR Type 2 diabetes mellitus with poor glucose control (defined as subject on insulin treatment, with HbA1c \> 9.0%, or with a modification in the oral anti-hyperglycemic medication regiment within the past 12 weeks prior to Visit 1)
* Subject with severe heart disease (Congestive heart failure (NYHA Class III-IV), ischemic heart disease within the past 6 months (unstable angina, myocardial infarction), peripheral vascular disease, history of Percutaneous Transluminal Coronary Angioplasty or Coronary Artery Bypass Grafting)
* Subject with clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically significant arrhythmia
* Subject with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, haemodynamically relevant stenosis of the aortic or mitral valve
* Subject with severe cerebrovascular disease (history of stroke, cerebral infarction, or cerebral hemorrhage within the past 6 months)
* Subject with or with a history of wasting disease, autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus), or connective tissue disease
* Subject with known moderate or malignant retinopathy (history of retinal signs of hemorrhage, visual impairment, retinal microaneurysm, etc. within the past 6 months)
* Subject with the following clinically significant laboratory abnormalities:
* AST or ALT \> 3 x Upper Limit Normal (ULN)
* Serum Creatinine \> 1.5 ULN
* Serum potassium \< 3.5 mmol/L or \> 5.5 mmol/L
* Subject with any surgical or medical condition of the gastrointestinal tract that might significantly alter the absorption, distribution, metabolism or excretion of the drug
* Subject with a history of malignant tumors including leukemia and lymphoma within the past 5 years (except for localized basal cell carcinoma of the skin)
* Subject with any chronic inflammatory condition needing chronic anti-inflammatory therapy
* Subject with chronic kidney disease on dialysis
* Subject with cardiogenic shock
* Subject requiring concomitant use of other antihypertensive or contraindicated drugs during the entire study period
* Subject with known or suspected contraindications, including history of allergy or hypersensitivity to ARB or dihydropyridine derivatives
* Subject who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or ARB
* Pregnant women, lactating mothers, women suspected of being pregnant, women who wish to be pregnant during the study, or women of child-bearing potential who are not using medically acceptable methods of contraception (oral contraceptive, intra-uterine device, condom, etc.), except for women with surgical sterilization. Pre-menopausal women who are not surgically sterilized must have a negative pregnancy test result at Visit 1 and maintain acceptable methods of contraception throughout the study. Periodic abstinence (eg, symptothermal, calendar, post-ovulation methods), or hormonal contraceptive are not acceptable methods of contraception
* History of drug or alcohol abuse within the past 1 year
* Use of other investigational products within the past 4 weeks
* Subject who are judged unsuitable to participate in the study in the opinion of the investigator
19 Years
75 Years
ALL
No
Sponsors
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HK inno.N Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Seung-Jea Tahk
Role: PRINCIPAL_INVESTIGATOR
Ajou University School of Medicine
Locations
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Seoul National University Bundang Hospital
Bundang, , South Korea
Dong-A University Hospital
Busan, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Konyang University Hospital
Daejeon, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Inje University Ilsan Paik Hospital
Ilsan, , South Korea
Inha University Hospital
Incheon, , South Korea
Hallym University Sacred Heart hospital
Kyungki-do, , South Korea
Inje University Haeundae Baik Hospital
Pusan, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Asan Medical Center
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Seoul Medical Center
Seoul, , South Korea
Seoul St. Mary's hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Soonchunhyang University Hospital
Seoul, , South Korea
Yonsei University Gangnam Severance Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Wonju Severance Christian Hospital
Wŏnju, , South Korea
Countries
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Central Contacts
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Other Identifiers
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CJ_CCA_201
Identifier Type: -
Identifier Source: org_study_id