Clinical Study for Patients With Hypertension Associated With Dyslipidemia

• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01764295
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 4
• Duration (Months): 10
• Patients Per Site Per Month: 15.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Dyslipidemia	Drug: DWJ1276; Drug: Olmesartan; Drug: Rosuvastatin; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DWJ1276 Once daily, administered orally, 8 week	Drug: DWJ1276
Active Comparator: Olmesartan Once daily, administered orally, 8 week	Drug: Olmesartan
Active Comparator: Rosuvastatin Once daily, administered orally, 8 week	Drug: Rosuvastatin
Placebo Comparator: Placebo Once daily, administered orally, 8 week	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. LDL-C percent change of DWJ1276 from baseline [8weeks]

2. DBP change of DWJ1276 from baseline [8weeks]

Secondary Outcome Measures

1. Proportion of subjects who reached LDL-C treatment goal defined by NCEP ATP III guideline [8weeks]

2. Proportion of subjects who reached blood pressure treatment goal defined by JNC VII report [8weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daewoong Pharmaceutical Co. LTD.
• ClinicalTrials.gov Identifier: NCT01764295
• Other Study ID Numbers: DW_DWJ1276003
• First Posted: Jan 9, 2013
• Last Update Posted: Aug 23, 2013
• Last Verified: Jan 1, 2013

• Additional relevant MeSH terms: Hypertension; Dyslipidemias; Olmesartan; Rosuvastatin Calcium

Study Results

No Results Posted as of Aug 23, 2013