Clinical Study for Patients With Hypertension Associated With Dyslipidemia

Daewoong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypertension; Dyslipidemia

Treatments: Drug: Olmesartan; Drug: DWJ1276; Drug: Rosuvastatin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01764295

DW_DWJ1276003

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of DWJ1276

Enrollment: 150 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult male and female in between ages of 20 and 80 at the time of screening
• Subject who can understand information provided and who can sign written consent voluntarily

Exclusion criteria

• Patients with hypersensitivity to olmesartan and rosuvastatin
• Pregnant or lactating women and fertile women who is not using proper contraceptive method
• Patient with history of drug or alcohol abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

---

150 participants in 4 patient groups, including a placebo group

DWJ1276

Experimental group

Description:

Once daily, administered orally, 8 week

Treatment:

Drug: DWJ1276

Olmesartan

Active Comparator group

Description:

Once daily, administered orally, 8 week

Treatment:

Drug: Olmesartan

Rosuvastatin

Active Comparator group

Description:

Once daily, administered orally, 8 week

Treatment:

Drug: Rosuvastatin

Placebo

Placebo Comparator group

Description:

Once daily, administered orally, 8 week

Treatment:

Drug: Placebo