Essential Hypertension
Conditions
Brief summary
A Multi-center, Randomized, Double-blind, Parallel design, Phase III study to Evaluate and Compare the Efficacy and Safety of DWC202405/DWC202313 and DWC202314 Combination Therapy to DWC202405/DWC202313 in Patients with Essential Hypertension Inadequately Controlled with DWC202405
Interventions
DRUGDWC202405
5/20mg, 1 tablet, Oral, Once a day
DRUGDWC202405, DWC202314
5/20mg + 1.5mg, 1 tablet, Oral, Once a day
DRUGDWC202405, DWC202314P
5/20mg + 1.5mg, 1 tablet, Oral, Once a day
10/40mg + 1.5mg, 1 tablet, Oral, Once a day
DRUGDWC202313, DWC202314P
10/40mg + 1.5mg, 1 tablet, Oral, Once a day
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Average systolic blood pressure (MSSBP) and average diastolic blood pressure (MSDBP) measured at the time of screening meet the following criteria (a) If antihypertensive drugs are being administered: 140 mmHg ≤ MSSBP \< 180 mmHg and MSDBP \< 110 mmHg However, the criteria of 130 mmHg ≤ MSSBP \< 180 mmHg and MSDBP \< 110 mmHg are applied to patients with the following diseases.
Exclusion criteria
* If the blood pressure measured at the time of screening and randomization is MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg * Those whose blood pressure differences measured on both arms at the time of screening are MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline | 8 weeks |
Countries
South Korea
Outcome results
None listed