A Dose Selection Trial of CKD-330 in Patients With Essential Hypertension
Primary Purpose
Essential Hypertension
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Candesartan 8mg
Candesartan 16mg
Amlodipine 5mg
Amlodipine 10mg
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension
Eligibility Criteria
Inclusion Criteria:
- Age of 18 or above
- Essential hypertension with 90mmHg ≤ mean sitDBP ≤ 115mmHg on target arm at Visit 3
- Ability to provide written informed consent
Exclusion Criteria:
- nean sitDBP ≥ 116mmHg or mean sitSBP ≥ 200mmHg at Visit 1, Visit 2, Visit 3
- The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1
- Known or suspected Stage 2 Hypertension (aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
- Patients with congestive heart failure(NYHA class III~IV), ischemic heart disease, cardiomyopathy, heart valve disorder, arrhythmia, coronary artery bypass graft
- History of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
- Type I Diabets Mellitus, Type II Diabetes Mellitus with HbA1c > 8%
- History of severe or malignant retinopathy
- AST/ALT > UNL * 2, Serum Creatinine > UNL * 1.5, K > 5.5mEq/L
- Patients with acute or chronic inflammatory status, autoimmune disease
- Patients who need to take antihypertensive drug besides Investigational products
- Patients must be treated with medications prohibited for concomitant use during study period
- Hypersensitive to Candesartan/Amlodipine or other dihydropyridine drugs
- Hereditary angioedema or history of angioedema related to ACE inhibitor or angiotensin II receptor blockers
- History of malignant tumor within 5 years
- Patients who are dependent on drugs or alcohol
- History of disability to drug absorption, active inflammatory bowel syndrome with 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract
- Patients treated with other investigational product within 4 weeks at the time concents are obtained
- Women with pregnant, breast-feeding
- Not eligible to participate for study at the discretion of investigator
Sites / Locations
- Seoul National University Bundang 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
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Candesartan 8mg + Amlodipine 5mg
Candesartan 8mg + Amlodipine 10mg
Candesartan 16mg + Amlodipine 5mg
Candesartan 16mg + Amlodipine 10mg
Candesartan 8mg
Candesartan 16mg
Amlodipine 5mg
Amlodipine 10mg
Arm Description
Candesartan 8mg + Amlodipine 5mg, po, q.d.
Candesartan 8mg + Amlodipine 10mg, po, q.d.
Candesartan 16mg + Amlodipine 5mg, po, q.d.
Candesartan 16mg + Amlodipine 10mg, po, q.d.
Candesartan 8mg, po, q.d.
Candesartan 16mg, po, q.d.
Amlodipine 5mg, po, q.d.
Amlodipine 10mg, po, q.d.
Outcomes
Primary Outcome Measures
The mean change of sitDBP (sitting diastolic blood pressure)
Secondary Outcome Measures
The mean change of sitDBP
The mean change of sitSBP
Responder rate: The change of sitDBP > 10mmHg, sitSBP > 20mmHg
Control rate: Patient achieving sitDBP < 90mmHg and sitSBP < 140mmHg
Full Information
NCT ID
NCT02206165
First Posted
June 16, 2014
Last Updated
March 27, 2015
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT02206165
Brief Title
A Dose Selection Trial of CKD-330 in Patients With Essential Hypertension
Official Title
A Randomized, Double-blind, Multi-center, Phase 2 Trial to Evaluate the Efficacy and Safety of Candesartan/Amlodipine Combined or Alone and Select Better Dose of CKD-330 in Patients With Essential Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Candesartan/Amlodipine combined or alone and select better dose of CKD-330 in essential hypertension patients.
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
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
456 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Candesartan 8mg + Amlodipine 5mg
Arm Type
Experimental
Arm Description
Candesartan 8mg + Amlodipine 5mg, po, q.d.
Arm Title
Candesartan 8mg + Amlodipine 10mg
Arm Type
Experimental
Arm Description
Candesartan 8mg + Amlodipine 10mg, po, q.d.
Arm Title
Candesartan 16mg + Amlodipine 5mg
Arm Type
Experimental
Arm Description
Candesartan 16mg + Amlodipine 5mg, po, q.d.
Arm Title
Candesartan 16mg + Amlodipine 10mg
Arm Type
Experimental
Arm Description
Candesartan 16mg + Amlodipine 10mg, po, q.d.
Arm Title
Candesartan 8mg
Arm Type
Active Comparator
Arm Description
Candesartan 8mg, po, q.d.
Arm Title
Candesartan 16mg
Arm Type
Active Comparator
Arm Description
Candesartan 16mg, po, q.d.
Arm Title
Amlodipine 5mg
Arm Type
Active Comparator
Arm Description
Amlodipine 5mg, po, q.d.
Arm Title
Amlodipine 10mg
Arm Type
Active Comparator
Arm Description
Amlodipine 10mg, po, q.d.
Intervention Type
Drug
Intervention Name(s)
Candesartan 8mg
Intervention Description
Once a day, 8 weeks
Intervention Type
Drug
Intervention Name(s)
Candesartan 16mg
Intervention Description
Once a day, 8 weeks
Intervention Type
Drug
Intervention Name(s)
Amlodipine 5mg
Intervention Description
Once a day, 8 weeks
Intervention Type
Drug
Intervention Name(s)
Amlodipine 10mg
Intervention Description
Once a day, 8 weeks
Primary Outcome Measure Information:
Title
The mean change of sitDBP (sitting diastolic blood pressure)
Time Frame
From baseline at week 8
Secondary Outcome Measure Information:
Title
The mean change of sitDBP
Time Frame
From baseline at week 4 and week 8
Title
The mean change of sitSBP
Time Frame
From baseline at week 4 and 8
Title
Responder rate: The change of sitDBP > 10mmHg, sitSBP > 20mmHg
Time Frame
From baseline at week 4 and 8
Title
Control rate: Patient achieving sitDBP < 90mmHg and sitSBP < 140mmHg
Time Frame
At week 4 and 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of 18 or above
Essential hypertension with 90mmHg ≤ mean sitDBP ≤ 115mmHg on target arm at Visit 3
Ability to provide written informed consent
Exclusion Criteria:
nean sitDBP ≥ 116mmHg or mean sitSBP ≥ 200mmHg at Visit 1, Visit 2, Visit 3
The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1
Known or suspected Stage 2 Hypertension (aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
Patients with congestive heart failure(NYHA class III~IV), ischemic heart disease, cardiomyopathy, heart valve disorder, arrhythmia, coronary artery bypass graft
History of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
Type I Diabets Mellitus, Type II Diabetes Mellitus with HbA1c > 8%
History of severe or malignant retinopathy
AST/ALT > UNL * 2, Serum Creatinine > UNL * 1.5, K > 5.5mEq/L
Patients with acute or chronic inflammatory status, autoimmune disease
Patients who need to take antihypertensive drug besides Investigational products
Patients must be treated with medications prohibited for concomitant use during study period
Hypersensitive to Candesartan/Amlodipine or other dihydropyridine drugs
Hereditary angioedema or history of angioedema related to ACE inhibitor or angiotensin II receptor blockers
History of malignant tumor within 5 years
Patients who are dependent on drugs or alcohol
History of disability to drug absorption, active inflammatory bowel syndrome with 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract
Patients treated with other investigational product within 4 weeks at the time concents are obtained
Women with pregnant, breast-feeding
Not eligible to participate for study at the discretion of investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HyunKyung Oh
Phone
82-2-2194-0469
Email
hkoh@ckdpharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheol-Ho Kim, M.D., Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheol-Ho Kim, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Cheol-Ho Kim, M.D., Ph.D.
12. IPD Sharing Statement
Learn more about this trial
A Dose Selection Trial of CKD-330 in Patients With Essential Hypertension
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