Hyperlipidemias, Hypertension
Conditions
Brief summary
This study aims to evaluate the efficacy and safety of co-administration of DWC202206 and DWC202207 in patients with concomitant hypertension and hyperlipidemia.
Detailed description
The study design is a randomized, double-blind, multicenter clinical trial. The patients were randomly assigned to each group. Primary endpoint was the change of MSSBP based on baseline between Treatment arm and control 1 arm and the change of LDL-C based on baseline between arm and control 2 arm.
Interventions
DRUG(D) DWC202206
Drug of DWC202206 A mg
DRUG(D) DWC202207
Drug of DWC202207 B/C mg
DRUG(P) DWC202206
Placebo of DWC202206 A mg
DRUG(P) DWC202207
Placebo of DWC202207 B/C mg
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 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 19 to 80 years * Patients with hypertension and hyperlipidemias
Exclusion criteria
* Orthostatic hypotension * History of ventricular tachycardia, atrial fibrillation * Uncontrolled diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline between treatment arm and control 1 arm | 8 weeks |
| The change of LDL-C based on baseline between treatment arm and control 2 arm | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline between treatment arm and control 1 arm | 4 weeks |
| The change of LDL-C based on baseline between treatment arm and control 2 arm | 4 weeks |
Countries
South Korea
Outcome results
None listed