Essential Hypertension
Conditions
Brief summary
The purpose of this study is to evaluate efficacy and safety of Irbesartan and Amlodipine combined therapy in patients with essential hypertension inadequately controlled on Irbesartan monotherapy
Interventions
Irbesartan/Amlodipine once daily for 8 weeks
DRUGIrbesartan
Irbesartan once daily for 8 weeks
Sponsors
Handok Inc.
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
* Patients who are 19 years or older on screening * Signed informed consent * Patients with Essential Hypertension * Other inclusion applied
Exclusion criteria
* Orthostatic hypotension with symptom * Other exclusion applied
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean sitting systolic blood pressure (mmHg) | Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Change form baseline in mean sitting systolic blood pressure (mmHg) | Week 4 |
| Change form baseline in mean sitting diastolic blood pressure (mmHg) | Week 4, 8 |
| Responder rate | Week 4, 8 |
| Target blood pressure reach rate | Week 4, 8 |
Countries
South Korea
Outcome results
None listed