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

S-amlodipine in Essential HypertensIon and Assessment of Blood Pressure Targets Achievement According to 2022 KSH(Korean Society of Hypertension) Guidelines (SHIFT)

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.

Study Overview

• Status: Recruiting
• Conditions: Essential Hypertension

Detailed Description

Primary purpose:

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.

Secondary purpose:

1. 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.
2. Evaluate the safety by checking the incidence (%) of adverse events after administration of the drug to be studied in patients with essential hypertension.
3. Evaluate the safety by checking the peripheral edema incidence rate (%) after administration of the drug to be studied in patients with essential hypertension.
4. Evaluate the safety by checking the headache incidence rate (%) after administration of the drug to be studied in patients with essential hypertension.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Yoojin Kim; Phone Number: 82-2-3489-6192; Email: dec11@hanlim.com

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Recruiting
      • Bundang Seoul University Hospital
      • Contact: In-Ho Chae; Email: ihchae@snubh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with essential hypertension who received Lodien Tab.

Description

Inclusion Criteria:

1. Adults over 19 years of age
2. 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)
3. A person whose prescription for the study drug under study was confirmed at the time of participation in the study
4. A person who voluntarily decided to participate in this observational study and gave written consent to the consent form

Exclusion Criteria:

1. 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
2. Patients who are inappropriate to participate in the study in the judgement of the investigator

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Estimated): April 22, 2025
• Study Completion (Estimated): July 25, 2025

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Estimated): November 14, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: HL-LDN-403

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No