Clinical Study for Patients With Hypertension Associated With Dyslipidemia

Phase 3

Completed

• Conditions: Hypertension; Dyslipidemia
• Interventions: Drug: DWJ1276; Drug: Olmesartan; Drug: Rosuvastatin; Drug: Placebo

• Registration Number: NCT01764295
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Status Verified: 2013-01
• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-09
• Primary Completion: 2013-05
• Study Completion: 2013-07
• Last Update Submitted: 2013-08-22
• Last Update Posted: 2013-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
DWJ1276	DWJ1276	Once daily, administered orally, 8 week
Olmesartan	Olmesartan	Once daily, administered orally, 8 week
Rosuvastatin	Rosuvastatin	Once daily, administered orally, 8 week
Placebo	Placebo	Once daily, administered orally, 8 week

Primary Outcome Measures

Name	Time	Method
LDL-C percent change of DWJ1276 from baseline	8weeks
DBP change of DWJ1276 from baseline	8weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who reached LDL-C treatment goal defined by NCEP ATP III guideline	8weeks
Proportion of subjects who reached blood pressure treatment goal defined by JNC VII report	8weeks

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of