search
Back to results

A Phase 2 Dose Selection Trial of Candesartan Cilexetil and Amlodipine Besylate to Treat Essential Hypertension

Primary Purpose

Essential Hypertension

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Amlodipine 5mg
Amlodipine 10mg
Candesartan Cilexetil 8mg
Candesartan cilexetil 16mg
Sponsored by
HK inno.N Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting
  • Dong-A University HospitalRecruiting
  • Yeungnam University Medical CenterRecruiting
  • Konyang University HospitalRecruiting
  • Chonnam National University HospitalRecruiting
  • Inje University Ilsan Paik HospitalRecruiting
  • Inha University HospitalRecruiting
  • Hallym University Sacred Heart hospitalRecruiting
  • Inje University Haeundae Baik HospitalRecruiting
  • Pusan National University HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Ewha Womans University Mokdong HospitalRecruiting
  • Korea University Guro HospitalRecruiting
  • Seoul Medical CenterRecruiting
  • Seoul St. Mary's hospitalRecruiting
  • Severance HospitalRecruiting
  • Soonchunhyang University HospitalRecruiting
  • Yonsei University Gangnam Severance HospitalRecruiting
  • Ajou University HospitalRecruiting
  • Wonju Severance Christian HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

AML 5mg

AML 10mg

CC 8mg

CC 16mg

AML 5mg/CC 8mg

AML 5mg/CC16mg

AML 10mg/CC 8mg

AML 10mg/CC 16mg

Arm Description

Amlodipine 5 mg, once a day for 8 weeks

Amlodipine 10 mg, once a day for 8 weeks

Candesartan Cilexetil 8 mg, once a day for 8 weeks

Candesartan Cilexetil 16 mg, once a day for 8 weeks

Amlodipine 5 mg and Candesartan 8 mg, once a day for 8 weeks

Amlodipine 5 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks

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

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

Outcomes

Primary Outcome Measures

Change in sitting Diastolic Blood Pressure (siDBP) at week 8 compared to baseline

Secondary Outcome Measures

Change in sitting Systolic Blood Pressure (siSBP) at week 4 and 8
Change in siDBP at week 4
Proportion of patients achieving ΔsiDBP > 10 mmHg and ΔsiSBP < 20 mmHg after 8 weeks
Proportion of patients achieving siDBP < 90 mmHg and siSBP < 120 mmHg after 8 weeks

Full Information

First Posted
February 10, 2014
Last Updated
April 29, 2014
Sponsor
HK inno.N Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT02059616
Brief Title
A Phase 2 Dose Selection Trial of Candesartan Cilexetil and Amlodipine Besylate to Treat Essential Hypertension
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HK inno.N Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AML 5mg
Arm Type
Experimental
Arm Description
Amlodipine 5 mg, once a day for 8 weeks
Arm Title
AML 10mg
Arm Type
Experimental
Arm Description
Amlodipine 10 mg, once a day for 8 weeks
Arm Title
CC 8mg
Arm Type
Experimental
Arm Description
Candesartan Cilexetil 8 mg, once a day for 8 weeks
Arm Title
CC 16mg
Arm Type
Experimental
Arm Description
Candesartan Cilexetil 16 mg, once a day for 8 weeks
Arm Title
AML 5mg/CC 8mg
Arm Type
Experimental
Arm Description
Amlodipine 5 mg and Candesartan 8 mg, once a day for 8 weeks
Arm Title
AML 5mg/CC16mg
Arm Type
Experimental
Arm Description
Amlodipine 5 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
Arm Title
AML 10mg/CC 8mg
Arm Type
Experimental
Arm Description
Amlodipine 10 mg and Candesartan Cilexetil 8 mg, once a day for 8 weeks
Arm Title
AML 10mg/CC 16mg
Arm Type
Experimental
Arm Description
Amlodipine 10 mg and Candesartan Cilexetil 16 mg, once a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Amlodipine 5mg
Other Intervention Name(s)
Norvasc 5mg
Intervention Description
Daily oral administration for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Amlodipine 10mg
Other Intervention Name(s)
Norvasc 10mg
Intervention Description
Daily oral administration for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Candesartan Cilexetil 8mg
Other Intervention Name(s)
Atacand 8mg
Intervention Description
Daily oral administration for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Candesartan cilexetil 16mg
Other Intervention Name(s)
Atacand 16mg
Intervention Description
Daily oral administration for 8 weeks
Primary Outcome Measure Information:
Title
Change in sitting Diastolic Blood Pressure (siDBP) at week 8 compared to baseline
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Change in sitting Systolic Blood Pressure (siSBP) at week 4 and 8
Time Frame
Week 4 and 8
Title
Change in siDBP at week 4
Time Frame
Week 4
Title
Proportion of patients achieving ΔsiDBP > 10 mmHg and ΔsiSBP < 20 mmHg after 8 weeks
Time Frame
Week 8
Title
Proportion of patients achieving siDBP < 90 mmHg and siSBP < 120 mmHg after 8 weeks
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geun Seog Song, PhD
Phone
82-2-6740-2440
Email
kssong1212@cj.net
First Name & Middle Initial & Last Name or Official Title & Degree
Eun Ji Kim
Phone
82-2-6740-2443
Email
keunji@cj.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Jea Tahk
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Bundang
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Konyang University Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Inje University Ilsan Paik Hospital
City
Ilsan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hallym University Sacred Heart hospital
City
Kyungki-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Inje University Haeundae Baik Hospital
City
Pusan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul St. Mary's hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Soonchunhyang University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Yonsei University Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-Jea Tahk
Facility Name
Wonju Severance Christian Hospital
City
Wonju
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

A Phase 2 Dose Selection Trial of Candesartan Cilexetil and Amlodipine Besylate to Treat Essential Hypertension

We'll reach out to this number within 24 hrs