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

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06130124
• Other study ID #: HL-LDN-403
• Status: Recruiting
• Start date: February 22, 2023
• Est. completion date: July 25, 2025

Study information

• Verified date: July 2023
• Source: Hanlim Pharm. Co., Ltd.
• Contact: Yoojin Kim
• Phone: 82-2-3489-6192
• Email: dec11[@]hanlim.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: July 25, 2025
• Est. primary completion date: April 22, 2025
• 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 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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Locations

Country	Name	City	State
Korea, Republic of	Bundang Seoul University Hospital	Seongnam-si	Gyeonggi-do

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 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