A Phase 2 Dose Selection Trial of Candesartan Cilexetil and Amlodipine Besylate to Treat Essential Hypertension
A Randomized, Double-blind, Multi-center, PhaseⅡ Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Candesartan Cilexetil and Amlodipine Besylate for the Dose Selection in Patients With Essential Hypertension
1 other identifier
interventional
384
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2014
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 10, 2014
CompletedFirst Posted
Study publicly available on registry
February 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedApril 30, 2014
April 1, 2014
1.3 years
February 10, 2014
April 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in sitting Diastolic Blood Pressure (siDBP) at week 8 compared to baseline
Week 8
Secondary Outcomes (4)
Change in sitting Systolic Blood Pressure (siSBP) at week 4 and 8
Week 4 and 8
Change in siDBP at week 4
Week 4
Proportion of patients achieving ΔsiDBP > 10 mmHg and ΔsiSBP < 20 mmHg after 8 weeks
Week 8
Proportion of patients achieving siDBP < 90 mmHg and siSBP < 120 mmHg after 8 weeks
Week 8
Study Arms (8)
AML 5mg
EXPERIMENTALAmlodipine 5 mg, once a day for 8 weeks
AML 10mg
EXPERIMENTALAmlodipine 10 mg, once a day for 8 weeks
CC 8mg
EXPERIMENTALCandesartan Cilexetil 8 mg, once a day for 8 weeks
CC 16mg
EXPERIMENTALCandesartan Cilexetil 16 mg, once a day for 8 weeks
AML 5mg/CC 8mg
EXPERIMENTALAmlodipine 5 mg and Candesartan 8 mg, once a day for 8 weeks
AML 5mg/CC16mg
EXPERIMENTALAmlodipine 5 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
AML 10mg/CC 8mg
EXPERIMENTALAmlodipine 10 mg and Candesartan Cilexetil 8 mg, once a day for 8 weeks
AML 10mg/CC 16mg
EXPERIMENTALAmlodipine 10 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
Interventions
Daily oral administration for 8 weeks
Daily oral administration for 8 weeks
Daily oral administration for 8 weeks
Daily oral administration for 8 weeks
Eligibility Criteria
You may qualify if:
- Male or female aged ≥ 19 and ≤ 75 years old
- 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
You may not qualify if:
- Subject with severe hypertension (siDBP ≥ 115 mmHg or siSBP ≥ 185 mmHg)
- 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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Jea Tahk
Ajou University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2014
First Posted
February 11, 2014
Study Start
February 1, 2014
Primary Completion
June 1, 2015
Study Completion
December 1, 2015
Last Updated
April 30, 2014
Record last verified: 2014-04