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NCT03009721 Clinical Trial

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

Hypertension Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03009721
Other study ID # DW_DOLO003
Secondary ID
Status Recruiting
Phase N/A
First received January 2, 2017
Last updated January 3, 2017
Start date August 2016
Est. completion date June 2018

Study information
Verified date January 2017
Source Daewoong Pharmaceutical Co. LTD.
Contact Daewoong Clinical
Phone +82-2-550-8800
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 9707
Est. completion date June 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• Other: Not applicable-observational study

Locations
Country Name City State
Korea, Republic of Dongguk Ilsan University Hospital Ilsan

Sponsors (1)
Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent change from baseline in blood pressure (SBP/DBP) At 8 Weeks No
Primary Percent change from baseline in LDL-Cholesterol (LDL-C) At 8 Weeks No
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