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NCT06214832 Clinical Trial

An Observation Study on the Identification of Prescription Patterns of Lodient Tab(Telmisartan/S-amlodipine)

Hypertension Clinical Trial

Official title:
An Observation Study on the Identification of Prescription Patterns of Lodient Tab(Telmisartan/S-amlodipine) and the Changes of Symptoms According to the Treatment Effect of Hypertension for Korean Hypertensive Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06214832
Other study ID # HL-LDNT-401
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 11, 2021
Est. completion date August 30, 2025

Study information
Verified date January 2024
Source Hanlim Pharm. Co., Ltd.
Contact Minseob Song
Phone +820222737282
Email song2you@naver.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study identify prescription patterns of Lodient Tab and evaluate the changes of the hypertension symptoms (BP pressure) who are first prescribed and taking Lodient Tab.

Description:

This study aims to observe changes in symptoms according to the treatment effect of hypertension for 6 months after Lodient Tab prescription.

Recruitment information / eligibility
Status Recruiting
Enrollment 4000
Est. completion date August 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. Adults over 19 years of age 2. A person diagnosed with hypertension 3. A person who has been first prescribed Lodient Tab within the past 4 months as of the IRB approval date or is scheduled to be prescribed Lodient Tab 4. A person who voluntarily agreed in writing to this study Exclusion Criteria: 1. Pregnant women or nursing mothers 2. Persons subject to prohibition according to the permission of the Lodient Tab 3. Patients who in the judgement of the investigator, were inappropriate to participate in the study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul song clinic Seoul

Sponsors (1)
Lead Sponsor Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The percentage of patients who met target systolic blood pressure (less than 140mmHg) at 6 months of prescription for Lodient Tab compared to baseline The percentage of patients who met target systolic blood pressure (less than 140mmHg) at 6 months of prescription for Lodient Tab compared to baseline at 6 months of prescription for Lodient Tab compared to baseline
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