Back to resultsThe Efficacy and Safety of OROSARTAN® Versus CODIOVAN® in Patients With Essential Hypertension Uncontrolled With Monotherapy
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
OROSARTAN® 5/160mg
CODIOVAN® 160/12.5mg
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- 19 aged or over
- A patient who was diagnosed with essential hypertension at screening(Visit 1)
- A patient understood objective of this clinical trial and gave their written informed consent voluntarily
Exclusion Criteria:
- A patient with severe hypertension(MSSBP≥200mmHg or MSDBP≥120mmHg) at Visit 1
- A subject with difference(as MSSBP≥20mmHg or MSDBP≥10mmHg) in blood pressure between right and left arm at screening evaluation
- Medical history or evidence of a secondary form of hypertension
- A subject with history of hypersensitivity to CCB(Calcium Channel Blocker), ARB(Angiotensin II Receptor Blocker) or sulfonamide
Sites / Locations
- Gachon University Gil Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Amlodipine orotate & Valsartan
Valsartan & Hydrochlorothiazide
Arm Description
Amlodipine orotate 6.91mg (5mg as amlodipine) and Valsartan 160 mg, tablet, once a day for 8 weeks
Valsartan 160mg and Hydrochlorothiazide 12.5mg, tablet, once a day for 8 weeks
Outcomes
Primary Outcome Measures
Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Secondary Outcome Measures
Change from baseline in MSDBP
Change from baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
Control rate in blood pressure
Rate of patients who achieved target blood pressure(MSDBP<90mmHg and MSSBP<140mmHg)
Responder rate in blood pressure
Rate of patients who achieved MSDBP≥10mmHg and MSSBP≥20mmHg decrease compared to baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02433119
Brief Title
The Efficacy and Safety of OROSARTAN® Versus CODIOVAN® in Patients With Essential Hypertension Uncontrolled With Monotherapy
Official Title
A Multi-center, Randomized, Double-blind, Phase IV Clinical Trial to Compare the Efficacy and Safety of OROSARTAN® Tablet 5/160mg Versus CODIOVAN® Tablet 160/12.5mg in Patients With Essential Hypertension Uncontrolled With Valsartan 160mg Monotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 16, 2015 (Actual)
Primary Completion Date
September 8, 2016 (Actual)
Study Completion Date
September 8, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
A multi-center, randomized, double-blind, phase IV clinical trial to compare the efficacy and safety of OROSARTAN® tablet 5/160mg versus CODIOVAN® tablet 160/12.5mg in patients with essential hypertension uncontrolled with valsartan 160mg monotherapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
238 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amlodipine orotate & Valsartan
Arm Type
Experimental
Arm Description
Amlodipine orotate 6.91mg (5mg as amlodipine) and Valsartan 160 mg, tablet, once a day for 8 weeks
Arm Title
Valsartan & Hydrochlorothiazide
Arm Type
Active Comparator
Arm Description
Valsartan 160mg and Hydrochlorothiazide 12.5mg, tablet, once a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
OROSARTAN® 5/160mg
Intervention Type
Drug
Intervention Name(s)
CODIOVAN® 160/12.5mg
Primary Outcome Measure Information:
Title
Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Change from baseline in MSDBP
Time Frame
Baseline, Week 4
Title
Change from baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
Time Frame
Baseline, Week 4 and 8
Title
Control rate in blood pressure
Description
Rate of patients who achieved target blood pressure(MSDBP<90mmHg and MSSBP<140mmHg)
Time Frame
Baseline, Week 8
Title
Responder rate in blood pressure
Description
Rate of patients who achieved MSDBP≥10mmHg and MSSBP≥20mmHg decrease compared to baseline
Time Frame
Baseline, Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
19 aged or over
A patient who was diagnosed with essential hypertension at screening(Visit 1)
A patient understood objective of this clinical trial and gave their written informed consent voluntarily
Exclusion Criteria:
A patient with severe hypertension(MSSBP≥200mmHg or MSDBP≥120mmHg) at Visit 1
A subject with difference(as MSSBP≥20mmHg or MSDBP≥10mmHg) in blood pressure between right and left arm at screening evaluation
Medical history or evidence of a secondary form of hypertension
A subject with history of hypersensitivity to CCB(Calcium Channel Blocker), ARB(Angiotensin II Receptor Blocker) or sulfonamide
Facility Information:
Facility Name
Gachon University Gil Hospital
City
Incheon
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of OROSARTAN® Versus CODIOVAN® in Patients With Essential Hypertension Uncontrolled With Monotherapy
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