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

NCT06130124 | Unknown

• 1 other identifier: HL-LDN-403
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with essential hypertension who received Lodien Tab.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

Bundang Seoul University Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yoojin Kim

CONTACT

82-2-3489-6192; dec11@hanlim.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 14, 2023
• Study Start: February 22, 2023
• Primary Completion: April 22, 2025
• Study Completion: July 25, 2025
• Last Updated: November 14, 2023

Record last verified: 2023-07

Locations

KR (1)