An Observation Study on the Identification of Prescriptio... | NCT06214832

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

NCT06214832

Sponsor

Hanlim Pharm. Co., Ltd.

Status

Unknown status

Last Update Posted

Jan 22, 2024Actual

Enrollment

4,000Estimated

Phase

Not provided

Conditions

Hypertension

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 11, 2021Actual

Primary Completion Date

Dec 30, 2024Estimated

Completion Date

Aug 30, 2025Estimated

First Submitted Date

Jan 3, 2024

First Submission Date that Met QC Criteria

Jan 17, 2024

First Posted Date

Jan 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2024

Last Update Posted Date

Jan 22, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults over 19 years of age
A person diagnosed with hypertension
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
A person who voluntarily agreed in writing to this study

Exclusion Criteria:

Pregnant women or nursing mothers
Persons subject to prohibition according to the permission of the Lodient Tab
Patients who in the judgement of the investigator, were inappropriate to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients Prescribed Lodient Tab for Hypertension Treatment

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Minseob Song	Contact	+820222737282		song2you@naver.com

Overall Officials

Name	Affiliation	Role
Minseob Song	Seoul song clinic	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul song clinic	Recruiting	Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided