Hypertension
Conditions
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
Interventions
DRUGOROSARTAN® 5/160mg
DRUGCODIOVAN® 160/12.5mg
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) | Baseline, Week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Rate of patients who achieved target blood pressure(MSDBP\<90mmHg and MSSBP\<140mmHg) |
| Responder rate in blood pressure | Baseline, Week 8 | Rate of patients who achieved MSDBP≥10mmHg and MSSBP≥20mmHg decrease compared to baseline |
Countries
South Korea
Outcome results
None listed