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A Study to Evaluate the Efficacy and Safety of Amlodipine Besylate and Candesartan Cilexetil in Essential Hypertension Patient Who Are Not Adequately Controlled With Candesartan Cilexetil Monotherapy

Sponsor
HK inno.N Corporation (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02368652
Collaborator
(none)
160
Enrollment
19
Locations
2
Arms
20
Duration (Months)
8.4
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Compare the safety and efficacy of amlodipine besylate and candesartan cilexetil combination therapy on patients of essential hypertension who are not properly controlled by candesartan cilexetil monotherapy.

Condition or Disease Intervention/Treatment Phase
  • Drug: Candesartan cilexetil 16mg
  • Drug: Amlodipine 10mg, Candesartan cilexetil 16mg
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Multi-center, Phase III Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Amlodipine Besylate and Candesartan Cilexetil Combination in Patients With Essential Hypertension Who Are Not Adequately Controlled With Candesartan Cilexetil Monotherapy
Study Start Date :
Oct 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: CC 16mg

Candesartan ceilexetil 16mg, once a day for 8 weeks

Drug: Candesartan cilexetil 16mg
Daily oral administration for 8 weeks
Other Names:
  • Atacand 16mg

    		•
    Experimental: AML 10mg / CC 16mg

    Amlodipine 10mg and Candesartan ceilexetil 16mg, once a day for 8 weeks

    Drug: Amlodipine 10mg, Candesartan cilexetil 16mg
    Daily oral administration for 8 weeks
    Other Names:
  • Norvasc 10mg, Atacand 16mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in sitting Diastolic Blood Pressure (siDBP) at week 8 compared to baseline [Week 8]

    Secondary Outcome Measures

    1. Change in siDBP at week 4 [Week 4]

    2. Change in sitting Systolic Blood Pressure (siSBP) at week 4 and 8 [Week 4 and 8]

    3. Proportion of patients achieving ΔsiDBP ≥ 10 mmHg and ΔsiSBP ≥ 20 mmHg after 8 weeks [Week 8]

    4. Proportion of patients achieving siDBP < 90 mmHg and siSBP < 140 mmHg after 8 weeks [Week 8]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female aged ≥ 19 and ≤ 75 years old

    • Subject with 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 who is siDBP ≥ 120 mmHg or siSBP ≥ 200 mmHg at Visit 1 (screening)

    • Subject with difference in the mean blood pressure of over 10 mmHg for siDBP or 20 mmHg 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 diseases, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, primary hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromo-cytoma, 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 supin position)

    • Subject with type 1 or type 2 diabetes mellitus with poor glucose control (defined as subject on inculin 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 3 or 4), ischemic heart disease within the past 6 months(unstable angina, myocardial infarction), peripheral blood vascula 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 cardiogenic shock

    • Subject with severe cerebrovascular disease (history of stroke, cerebral infraction, or cerebral hemorrhage within the past 6 months)

    • Subject with a history of or ongoing wasting disease, autoimmune diseases(rheumatoid arthritis, systemic lupus erythematosus, etc.) 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 any surgical or medical condition of the gastrointestinal tract that might sugnificantly 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 yesrs(except for localized basal cell carcinoma of the skin)

    • Subject with any chronic inflammatory condition needing chronic anti-inflammatory therapy

    • Subject with chronic kidney disase on dialysis

    • 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 > 5.5mmol/L

    • 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 or lactating mother, 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 contraceptinve, 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 Visit1 and maintain acceptable methods of contraception throughout the study. preiodic 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 jdged unsuitable to participate in the study in the opinion of the investigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hallym University Sungsim Hospital Anyang-si Korea, Republic of
    2 Inje University Busan Baik Hospital Busan Korea, Republic of
    3 Inje University Haeundae Baik Hospital Busan Korea, Republic of
    4 Yeungnam University Medical Center Daegu Korea, Republic of
    5 Chonnam National University Hospital Gwangju Korea, Republic of
    6 Inje University Ilsan Baik Hospital Ilsan Korea, Republic of
    7 Inha University Hospital Incheon Korea, Republic of
    8 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of
    9 Asan Medical Center Seoul Korea, Republic of
    10 Ewha Womans University Mokdong Hospital Seoul Korea, Republic of
    11 Gangbuk Samsung Hospital Seoul Korea, Republic of
    12 Korea University Anam Hospital Seoul Korea, Republic of
    13 Korea University Guro Hospital Seoul Korea, Republic of
    14 Seoul Medical Center Seoul Korea, Republic of
    15 Seoul St. Mary's Hospital Catholic University Seoul Korea, Republic of
    16 Soonchunhyang University Hospital Seoul Korea, Republic of
    17 Yonsei University Severance Hospital Seoul Korea, Republic of
    18 Ajou University Hospital Suwon Korea, Republic of
    19 Wonju Severance Christian Hospital Wonju Korea, Republic of

    Sponsors and Collaborators

    • HK inno.N Corporation

    Investigators

    • Principal Investigator: Seungjae Tahk, Ajou University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HK inno.N Corporation
    ClinicalTrials.gov Identifier:
    NCT02368652
    Other Study ID Numbers:
    • CJ_CCA_301A
    First Posted:
    Feb 23, 2015
    Last Update Posted:
    Feb 23, 2015
    Last Verified:
    Oct 1, 2014
    Additional relevant MeSH terms:
    Hypertension
    Essential Hypertension
    Amlodipine
    Candesartan
    Candesartan cilexetil

    Study Results

    No Results Posted as of Feb 23, 2015