Comparison of Efficacy and Safety of Combination Therapy and Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension
- Conditions
- Essential Hypertension
- Interventions
- Registration Number
- NCT02944734
- Lead Sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 392
- Male or female patients greater than or equal to 19 years of age
- 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)
- Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form
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Subject with severe hypertension (in a selected arm with msSBP ≥ 200 mmHg or msDBP ≥ 115 mmHg) during the Screening and Randomized Trial.
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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
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Secondary hypertension (such as, coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.)
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Symptomatic orthostatic hypotension
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Severe heart failure( New York Heart Association(NYHA) Class III/IV)
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Subject with acute coronary syndrome(myocardial infarction or unstable angina), peripheral vascular disease within the past 6 months
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History of switching to another Antiarrhythmic drugs(not including electrolyte correction), or received Cardioversion or ICU treatment within the past 6 months
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Type 1 diabetes mellitus or Uncontrolled Type 2 diabetes mellitus (HbA1c > 9.0%)
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Subject with Haemodynamic disturbance, heart valve disease with structural defects
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Severe cerebrovascular disease (stroke, cerebral infarction, or cerebral hemorrhage, etc. within the past 6 months)
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Severe eye disease (retinal hemorrhage, visual impairment, retinal microaneurysm, etc. within the past 6 months)
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Autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
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Chronic inflammatory disease requiring continuous anti-inflammatory treatment
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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)
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Hypokalaemia(Serum potassium < 3.5 mmol/L) or hyperkalaemia(Serum potassium > 5.5 mmol/L)
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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
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history of allergy or hypersensitivity to Angiotensin II Receptor Blockers(Candesartan) or Calcium Channel Blocker(amlodipine)
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Subject with heredity defects such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
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Subject requiring concomitant use of other antihypertensive or contraindicated drugs( Tizanidine, dolasetron, Itraconazole, potassium, potassium-sparing diuretics, etc.) during the clinical trial
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history of malignant tumors within the past 5 years
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history of alcohol or drug abuse
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Pregnant women and lactating mothers
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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.
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Use of other investigational products within the past 1 month
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Subject who are judged by the investigator unsuitable to participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CC 16mg / AML 5mg Candesartan Cilexetil 16mg Candesartan 16mg and Amlodipine 5mg, once a day for 8 weeks Candesartan Cilexetil (CC) 8mg Candesartan Cilexetil 8mg Candesartan Cilexetil 8mg, once a day for 8 weeks CC 8mg / AML 10mg Candesartan Cilexetil 8mg Candesartan 8mg and Amlodipine 10mg, once a day for 8 weeks CC 16mg Candesartan Cilexetil 16mg Candesartan Cilexetil 16mg, once a day for 8 weeks CC 8mg / AML 5mg Candesartan Cilexetil 8mg Candesartan 8mg and Amlodipine 5mg, once a day for 8 weeks CC 16mg / AML 10mg Candesartan Cilexetil 16mg Candesartan 16mg and Amlodipine 10mg, once a day for 8 weeks Amlodipine(AML) 5mg Amlodipine 5mg Amlodipine 5mg, once a day for 8 weeks AML 10mg Amlodipine 10mg Amlodipine 10mg, once a day for 8 weeks CC 8mg / AML 5mg Amlodipine 5mg Candesartan 8mg and Amlodipine 5mg, once a day for 8 weeks CC 8mg / AML 10mg Amlodipine 10mg Candesartan 8mg and Amlodipine 10mg, once a day for 8 weeks CC 16mg / AML 5mg Amlodipine 5mg Candesartan 16mg and Amlodipine 5mg, once a day for 8 weeks CC 16mg / AML 10mg Amlodipine 10mg Candesartan 16mg and Amlodipine 10mg, once a day for 8 weeks
- Primary Outcome Measures
Name Time Method Change mean sitting Diastolic Blood Pressure (msDBP) at week 8 compared to baseline Week 8
- Secondary Outcome Measures
Name Time Method Change mean sitting Diastolic Blood Pressure (msDBP) at week 4 compared to baseline Week 4 Change mean sitting Systolic Blood Pressure (msSBP) at week 4 and 8 compared to baseline Week 4 and 8 Proportion of patients achieving treatment goal at week 4 and 8: < 140/90 mmHg Week 4 and 8 Joint National Committee VII Guideline Treatment goal: \< 140/90 mmHg (\< 130/80 mmHg, diabetic or chronic renal failure patient)
Blood Pressure Response rate at week 4 and 8: msSBP reduction ≥ 20 mmHg and msDBP reduction ≥ 10 mmHg Week 4 and 8
Trial Locations
- Locations (23)
Kyungpook National University Hospital
🇰🇷Joong-gu, Daegu, Korea, Republic of
Catholic University of Korea Bucheon St. Mary's Hospital
🇰🇷Wonmi-gu, Bucheon, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busanjin-gu, Busan, Korea, Republic of
Catholic University of Korea Uijeongbu St. Mary's hospital
🇰🇷Uijeongbu-si, Gyeoggi-do, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wonju, Kangwon-Do, Korea, Republic of
Gachon University Gil Hospital
🇰🇷Namdong-gu, Incheon, Korea, Republic of
VHS( Veterans Medical Service) Medical Center
🇰🇷Gangdong-gu, Seoul, Korea, Republic of
St. Carollo General Hospital
🇰🇷Suncheon-si, Jeollanam-do, Korea, Republic of
Catholic University of Korea St. Paul's Hospital
🇰🇷Dongdaemun-gu, Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Gwangjin-gu, Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seongbuk-Gu, Seoul, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Nam- gu, Daegu, Korea, Republic of
Chonnam National University Hospital
🇰🇷Dong-Gu, Gwangju, Korea, Republic of
Dongguk University Ilsan Hospital
🇰🇷Ilsandong-gu, Goyang-si, Gyeoggi-do, Korea, Republic of
KyungHee University Medical Center
🇰🇷Dongdaemun-gu, Seoul, Korea, Republic of
Hallym University Kangdong Sacred Heart Hospital
🇰🇷Gangdong-gu, Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Dong-gu, Ulsan, Korea, Republic of
Catholic University of Korea Seoul St. Mary's Hospital
🇰🇷Seocho-Gu, Seoul, Korea, Republic of
Kyung Hee University Hospital at Gangdong
🇰🇷Gangdong-Gu, Seoul, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Joong-gu, Daegu, Korea, Republic of
Pusan National University Hospital
🇰🇷Seo-gu, Busan, Korea, Republic of
Seoul National University Hospital
🇰🇷Jongro-gu, Seoul, Korea, Republic of
Catholic University of Korea Yeouido St. Mary's Hospital
🇰🇷Yeongdeungpo-gu, Seoul, Korea, Republic of