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Clinical Study for Patients With Hypertension Associated With Dyslipidemia

NCT ID: NCT01764295

Last Updated: 2013-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-07-31

Brief Summary

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

Detailed Description

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Conditions

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Hypertension Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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DWJ1276

Once daily, administered orally, 8 week

Group Type EXPERIMENTAL

DWJ1276

Intervention Type DRUG

Olmesartan

Once daily, administered orally, 8 week

Group Type ACTIVE_COMPARATOR

Olmesartan

Intervention Type DRUG

Rosuvastatin

Once daily, administered orally, 8 week

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

Placebo

Once daily, administered orally, 8 week

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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DWJ1276

Intervention Type DRUG

Olmesartan

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW_DWJ1276003

Identifier Type: -

Identifier Source: org_study_id