Essential Hypertension
Conditions
Brief summary
A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension
Interventions
QID
Sponsors
Handok Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are 19 years or older / 75 years or younger on screening * Signed informed consent * Patients with Essential Hypertension * Other inclusion applied
Exclusion criteria
* Orthostatic hypertension with symptom * Other exclusion applied
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in MSSBP between baseline and Week8. | Baseline and Week8 | The primary efficacy variable was the change in Mean Sitting Systolic Blood Pressure between baseline and Week8. |
Secondary
| Measure | Time frame |
|---|---|
| The change in MSSBP between baseline and Week4. | Baseline and Week4 |
| The change in Mean Sitting Diastolic Blood Pressure between baseline and Week4 / Week8. | Baseline and Week4/8 |
| The proportion of patients having reached MSSBP < 140 mmHg and MSDBP < 90 mmHg at W4 and at W8. | Baseline and Week4/8 |
Countries
South Korea
Outcome results
None listed