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NCT05411887 Clinical Trial

Study to Evaluate the Effect of Improving Systolic BP and LDL-C Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab

Hypertension Clinical Trial

Official title:
A Non-interventional, Multi Center, Prospective Observational Study to Evaluate the Effect of Improving Systolic Blood Pressure and Low-density Lipoprotein Cholesterol Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab. in Patients With Essential Hypertension and Dyslipidemia.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05411887
Other study ID # DWOS_OLO_004
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 20, 2022
Est. completion date October 1, 2024

Study information
Verified date June 2022
Source Daewoong Pharmaceutical Co. LTD.
Contact HyeongSeon Noh
Phone +821042660549
Email hsno116@daewoong.co.kr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of Olostar Tablet on blood pressure and lipid profiles, obtain safety-related information for subgroups that failed to participate in the clinical trials, and to evaluate variables that affect treatment effectiveness.

Recruitment information / eligibility
Status Recruiting
Enrollment 3000
Est. completion date October 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. men and women over the age of 19 2. Patients who signed a written consent form to participate in the study 3. Patients who are eligible for Olostar tablet prescription according to domestic permission Exclusion Criteria: 1. A person who falls under "2. Do not administer to the following patients" among the precautions for use in the user manual 2. Patients in hospital (hospitals only; nursing care facilities can be recruited) 3. A person who has been administered the study target drug or is being administered at the time of recruitment within 6 months based on the date of the study contract

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Rosuvastatin, Olmesartan Medoxomil
Olostar Tablet

Locations
Country Name City State
Korea, Republic of Severance Hospital Seoul

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 Hypertension reduction rate To evaluate effectiveness of Olostar Tablet on hypertension 24 weeks
Primary Lipid profile reduction rate To evaluate effectiveness of Olostar Tablet on lipid profile. 24 weeks
Secondary Treatment objectives To evaluate whether treatment objectives (hypertension, LDL-C) have been achieved. 24 weeks
Secondary Construct prediction model Construct a treatment effectiveness prediction model based on effectiveness of Olostar Tablet treatment (whether treatment goals are achieved or not). 24 weeks
Secondary Construct prediction model Construct a compliance and persistence prediction model based on patients receiving Olostar Tablet treatment. 24 weeks
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