- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03009721
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 Contact
- Name: Daewoong Clinical
- Phone Number: 8800 +82-2-550-8800
Study Locations
-
-
-
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
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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