- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02059616
A Phase 2 Dose Selection Trial of Candesartan Cilexetil and Amlodipine Besylate to Treat Essential Hypertension
April 29, 2014 updated by: HK inno.N Corporation
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
384
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Geun Seog Song, PhD
- Phone Number: 82-2-6740-2440
- Email: kssong1212@cj.net
Study Contact Backup
- Name: Eun Ji Kim
- Phone Number: 82-2-6740-2443
- Email: keunji@cj.net
Study Locations
-
-
-
Bundang, Korea, Republic of
- Recruiting
- Seoul National University Bundang Hospital
-
Busan, Korea, Republic of
- Recruiting
- Dong-A University Hospital
-
Daegu, Korea, Republic of
- Recruiting
- Yeungnam University Medical Center
-
Daejeon, Korea, Republic of
- Recruiting
- Konyang University Hospital
-
Gwangju, Korea, Republic of
- Recruiting
- Chonnam National University Hospital
-
Ilsan, Korea, Republic of
- Recruiting
- Inje University Ilsan Paik Hospital
-
Incheon, Korea, Republic of
- Recruiting
- Inha University Hospital
-
Kyungki-do, Korea, Republic of
- Recruiting
- Hallym University Sacred Heart Hospital
-
Pusan, Korea, Republic of
- Recruiting
- Pusan National University Hospital
-
Pusan, Korea, Republic of
- Recruiting
- Inje University Haeundae Baik Hospital
-
Seoul, Korea, Republic of
- Recruiting
- Asan Medical Center
-
Seoul, Korea, Republic of
- Recruiting
- Severance Hospital
-
Seoul, Korea, Republic of
- Recruiting
- Seoul st. mary's hospital
-
Seoul, Korea, Republic of
- Recruiting
- Ewha Womans University Mokdong Hospital
-
Seoul, Korea, Republic of
- Recruiting
- Soonchunhyang University Hospital
-
Seoul, Korea, Republic of
- Recruiting
- Korea University Guro Hospital
-
Seoul, Korea, Republic of
- Recruiting
- Seoul Medical Center
-
Seoul, Korea, Republic of
- Recruiting
- Yonsei University Gangnam Severance Hospital
-
Suwon, Korea, Republic of
- Recruiting
- Ajou University Hospital
-
Principal Investigator:
- Seung-Jea Tahk
-
Wonju, Korea, Republic of
- Recruiting
- Wonju Severance Christian Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AML 5mg
Amlodipine 5 mg, once a day for 8 weeks
|
Daily oral administration for 8 weeks
Other Names:
|
Experimental: AML 10mg
Amlodipine 10 mg, once a day for 8 weeks
|
Daily oral administration for 8 weeks
Other Names:
|
Experimental: CC 8mg
Candesartan Cilexetil 8 mg, once a day for 8 weeks
|
Daily oral administration for 8 weeks
Other Names:
|
Experimental: CC 16mg
Candesartan Cilexetil 16 mg, once a day for 8 weeks
|
Daily oral administration for 8 weeks
Other Names:
|
Experimental: AML 5mg/CC 8mg
Amlodipine 5 mg and Candesartan 8 mg, once a day for 8 weeks
|
Daily oral administration for 8 weeks
Other Names:
Daily oral administration for 8 weeks
Other Names:
|
Experimental: AML 5mg/CC16mg
Amlodipine 5 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
|
Daily oral administration for 8 weeks
Other Names:
Daily oral administration for 8 weeks
Other Names:
|
Experimental: AML 10mg/CC 8mg
Amlodipine 10 mg and Candesartan Cilexetil 8 mg, once a day for 8 weeks
|
Daily oral administration for 8 weeks
Other Names:
Daily oral administration for 8 weeks
Other Names:
|
Experimental: AML 10mg/CC 16mg
Amlodipine 10 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
|
Daily oral administration for 8 weeks
Other Names:
Daily oral administration for 8 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in sitting Diastolic Blood Pressure (siDBP) at week 8 compared to baseline
Time Frame: Week 8
|
Week 8
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in siDBP at week 4
Time Frame: Week 4
|
Week 4
|
Change in sitting Systolic Blood Pressure (siSBP) at week 4 and 8
Time Frame: Week 4 and 8
|
Week 4 and 8
|
Proportion of patients achieving ΔsiDBP > 10 mmHg and ΔsiSBP < 20 mmHg after 8 weeks
Time Frame: Week 8
|
Week 8
|
Proportion of patients achieving siDBP < 90 mmHg and siSBP < 120 mmHg after 8 weeks
Time Frame: Week 8
|
Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Seung-Jea Tahk, Ajou University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Anticipated)
June 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
February 10, 2014
First Submitted That Met QC Criteria
February 10, 2014
First Posted (Estimate)
February 11, 2014
Study Record Updates
Last Update Posted (Estimate)
April 30, 2014
Last Update Submitted That Met QC Criteria
April 29, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Essential Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Amlodipine
- Candesartan
- Candesartan cilexetil
Other Study ID Numbers
- CJ_CCA_201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Essential Hypertension
-
Addpharma Inc.Completed
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
BayerCompletedHypertension, EssentialGermany
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
Addpharma Inc.Not yet recruitingHypertension,Essential
-
Instituto de Cardiologia do Rio Grande do SulRecruitingHypertension | Hypertension,EssentialBrazil
-
Federal University of Health Science of Porto AlegreIrmandade Santa Casa de Misericórdia de Porto Alegre; Leonhardt Ventures LLCNot yet recruitingHypertension | Hypertension,Essential
Clinical Trials on Candesartan cilexetil 16mg
-
HK inno.N CorporationCompleted
-
HK inno.N CorporationCompleted
-
Shin Poong Pharmaceutical Co. Ltd.CompletedEssential HypertensionKorea, Republic of
-
AstraZenecaCompletedNon-diabetic Nephropathy With HypertensionKorea, Republic of
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompletedCardiovascular DiseaseIndia
-
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyTerminatedChronic Heart Failure | High Blood B-type (or Brain) Natriuretic Peptide (BNP) LevelGermany, France, Netherlands
-
AstraZenecaCompleted