Observational Study to Investigate the Effectiveness and Safety of Olostar Tab in Patients With Essential Hypertension and Dyslipidemia

January 3, 2017 updated by: Daewoong Pharmaceutical Co. LTD.

A Non-interventional, Multi-center, Retrospective Observational Study to Investigate the Effectiveness and Safety of Olostar Tab in Patients With Essential Hypertension and Dyslipidemia (ROSE Study)

The purpose of this study is to investigate the effectiveness and safety of Olostar Tab in patients with essential hypertension and dyslipidemia

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

9707

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

  • Korea, Republic of
      • Ilsan, Korea, Republic of
        • Recruiting
        • Dongguk Ilsan University Hospital
        • Contact:
          • Daewoong Clinical

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with essential hypertension and dyslipidemia

Description

Inclusion Criteria:

  • Male or female ≥ 19
  • Patients have record of blood pressure (SBP/DBP) and LDL-C after prescription of Olostar Tab.

Exclusion Criteria:

  • Patients that have participated clinical trials or PMS with Olostar Tab.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline in blood pressure (SBP/DBP)
Time Frame: At 8 Weeks
At 8 Weeks
Percent change from baseline in LDL-Cholesterol (LDL-C)
Time Frame: At 8 Weeks
At 8 Weeks

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

August 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

January 2, 2017

First Submitted That Met QC Criteria

January 3, 2017

First Posted (Estimate)

January 4, 2017

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_DOLO003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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