Essential Hypertension, Hypertension
Conditions
Brief summary
A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of DWC202404 and DWC202314 Combination Therapy in Patients with Essential Hypertension Inadequately Controlled on DWC202404 Monotherapy
Interventions
DRUGDWC202404, DWC202314
\- 2 tablet, Oral, Once a day
DRUGDWC202404, DWC202314P
\- 2 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) measured at the time of screening meet the following criteria (a) If anti-hypertensive drugs are not being administered: 140 mmHg ≤ MSSBP \< 180 mmHg (b) If anti-hypertensive drugs are being administered: 130 mmHg ≤ MSSBP \< 180 mmHg
Exclusion criteria
* If the blood pressure measured at the time of screening and randomization is 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