Clinical Study for Patients With Hypertension Associated With Dyslipidemia

August 22, 2013 updated by: Daewoong Pharmaceutical Co. LTD.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LDL-C percent change of DWJ1276 from baseline
Time Frame: 8weeks
8weeks
DBP change of DWJ1276 from baseline
Time Frame: 8weeks
8weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

January 7, 2013

First Submitted That Met QC Criteria

January 8, 2013

First Posted (Estimate)

January 9, 2013

Study Record Updates

Last Update Posted (Estimate)

August 23, 2013

Last Update Submitted That Met QC Criteria

August 22, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_DWJ1276003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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