NCT02433119CompletedPhase 4
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 238
- Locations
- 1
- Primary Endpoint
- Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Amlodipine orotate & Valsartan
Experimental
Amlodipine orotate 6.91mg (5mg as amlodipine) and Valsartan 160 mg, tablet, once a day for 8 weeks
Intervention: OROSARTAN® 5/160mg (Drug)
Valsartan & Hydrochlorothiazide
Active Comparator
Valsartan 160mg and Hydrochlorothiazide 12.5mg, tablet, once a day for 8 weeks
Intervention: CODIOVAN® 160/12.5mg (Drug)
Outcomes
Primary Outcomes
Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Time Frame: Baseline, Week 8
Secondary Outcomes
- Responder rate in blood pressure(Baseline, Week 8)
- Change from baseline in MSDBP(Baseline, Week 4)
- Change from baseline in Mean Sitting Systolic Blood Pressure (MSSBP)(Baseline, Week 4 and 8)
- Control rate in blood pressure(Baseline, Week 8)
Investigators
Study Sites (1)
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