Dyslipidemia, Hypertension
Conditions
Brief summary
A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0104+C2402 in Patients with Hypertension and Dyslipidemia
Detailed description
To evaluate the efficacy and safety of co-administration of JW0104+C2402 in comparison with co-administration of JW0104+C2403 or C2402 alone in patients with hypertension and dyslipidemia.
Interventions
DRUGJW0104+C2402
For 8 weeks(PO (Per Oral), QD)
DRUGJW0104+C2403
For 8 weeks(PO, QD)
DRUGC2402
For 8 weeks(PO, QD)
Sponsors
JW Pharmaceutical
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 with hypertension and dyslipidemia
Exclusion criteria
* The subject not meet the specified msBP and LDL-C level
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in msSBP (Systolic Blood Pressure) | week 8 | Check msSBP |
| Percent change from baseline in LDL-C (Low-Density Lipoprotein Cholesterol) | week 8 | Check LDL-C |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in msSBP | week 4 | Check msSBP |
| Change and percent change from baseline in LDL-C | week 4 | Check LDL-C |
Countries
South Korea
Contacts
Primary ContactMinjung Kim
Backup ContactDongryung Lee
Outcome results
None listed