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Clinical Study for Patients With Hypertension Associated With Dyslipidemia

Primary Purpose

Hypertension, Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWJ1276
Olmesartan
Rosuvastatin
Placebo
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

DWJ1276

Olmesartan

Rosuvastatin

Placebo

Arm Description

Once daily, administered orally, 8 week

Once daily, administered orally, 8 week

Once daily, administered orally, 8 week

Once daily, administered orally, 8 week

Outcomes

Primary Outcome Measures

LDL-C percent change of DWJ1276 from baseline
DBP change of DWJ1276 from baseline

Secondary Outcome Measures

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

Full Information

First Posted
January 7, 2013
Last Updated
August 22, 2013
Sponsor
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT01764295
Brief Title
Clinical Study for Patients With Hypertension Associated With Dyslipidemia
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 Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DWJ1276
Arm Type
Experimental
Arm Description
Once daily, administered orally, 8 week
Arm Title
Olmesartan
Arm Type
Active Comparator
Arm Description
Once daily, administered orally, 8 week
Arm Title
Rosuvastatin
Arm Type
Active Comparator
Arm Description
Once daily, administered orally, 8 week
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Once daily, administered orally, 8 week
Intervention Type
Drug
Intervention Name(s)
DWJ1276
Intervention Type
Drug
Intervention Name(s)
Olmesartan
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
LDL-C percent change of DWJ1276 from baseline
Time Frame
8weeks
Title
DBP change of DWJ1276 from baseline
Time Frame
8weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects who reached LDL-C treatment goal defined by NCEP ATP III guideline
Time Frame
8weeks
Title
Proportion of subjects who reached blood pressure treatment goal defined by JNC VII report
Time Frame
8weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Clinical Study for Patients With Hypertension Associated With Dyslipidemia

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