Clinical Study for Patients With Hypertension Associated With Dyslipidemia

Hypertension Clinical Trial

Official title:

Multi-institutional, Randomized, Double-Blind, Placebo-Control, Factorial Design, 4-arms, 8 Week Administration, Phase 3 Clinical Study for Patients With Hypertension Associated With Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764295
• Other study ID #: DW_DWJ1276003
• Status: Completed
• Phase: Phase 3
• First received: January 7, 2013
• Last updated: August 22, 2013
• Start date: September 2012
• Est. completion date: July 2013

Study information

• Verified date: January 2013
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertension

Intervention

Drug:
• DWJ1276

• Olmesartan

• Rosuvastatin

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-C percent change of DWJ1276 from baseline		8weeks	No
Primary	DBP change of DWJ1276 from baseline		8weeks	No
Secondary	Proportion of subjects who reached LDL-C treatment goal defined by NCEP ATP III guideline		8weeks	No
Secondary	Proportion of subjects who reached blood pressure treatment goal defined by JNC VII report		8weeks	No