S-amlodipine in Essential HypertensIon and Assessment of... | NCT06130124

Studies
S-amlodipine in Essential HypertensIon and Assessment of Blood Pressure Targets Achievement

NCT06130124

Sponsor

Hanlim Pharm. Co., Ltd.

Status

Unknown status

Last Update Posted

Nov 14, 2023Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Essential 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

Jul 2023

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

Feb 22, 2023Actual

Primary Completion Date

Apr 22, 2025Estimated

Completion Date

Jul 25, 2025Estimated

First Submitted Date

Nov 8, 2023

First Submission Date that Met QC Criteria

Nov 8, 2023

First Posted Date

Nov 14, 2023Actual

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

Nov 8, 2023

Last Update Posted Date

Nov 14, 2023Actual

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

Evaluate the ratio(%) of patients whose blood pressure measured at 6 months from the baseline was confirmed to be within the target blood pressure range according to the 2022 hypertension treatment guidelines for essential hypertension patients who received the study drug.

Detailed Description

Primary purpose:

Secondary purpose:

Evaluate the efficacy by comparing the change in blood pressure for each drug pattern (monotherapy or combination therapy) at 6 months after administration of the drug to be studied in patients with essential hypertension.
Evaluate the safety by checking the incidence (%) of adverse events after administration of the drug to be studied in patients with essential hypertension.
Evaluate the safety by checking the peripheral edema incidence rate (%) after administration of the drug to be studied in patients with essential hypertension.
Evaluate the safety by checking the headache incidence rate (%) after administration of the drug to be studied in patients with essential hypertension.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The ratio(%) of patients whose blood pressure measured at 6 months from the baseline was confirmed to be within the target blood pressure range according to the 2022 hypertension treatment guidelines	The ratio(%) of patients whose blood pressure measured at 6 months from the baseline was confirmed to be within the target blood pressure range according to the 2022 hypertension treatment guidelines for essential hypertension patients who received the study drug	after 6 months of prescription for S-Amlodipine 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 who was diagnosed with essential hypertension at the time of participation in the study or was previously diagnosed with essential hypertension and is taking antihypertensive drugs for treatment (Essential hypertension: Systolic blood pressure greater than 140mmHg or diastolic blood pressure greater than 90mmHg)
A person whose prescription for the study drug under study was confirmed at the time of participation in the study
A person who voluntarily decided to participate in this observational study and gave written consent to the consent form

Exclusion Criteria:

Patients who are contraindicated in administration of study drug according to the permission
- Patients with a history of hypersensitivity to the study drug or its components or other dihydropyridine-based drugs
- Women who are pregnant or may be pregnant, and women who are lactating
- Patients with shock (including cardiogenic shock), severe aortic valve stenosis, unstable angina, within 1 month after myocardial infarction, severe hypotension, severe liver dysfunction
Patients who are inappropriate to participate in the study in the judgement of the investigator

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 with essential hypertension who received Lodien Tab.

Sampling Method

Probability Sample

ID	Term
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases