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

Hanlim Pharm. Co., Ltd.5,000 enrolled

Overview

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.

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

5,000

Conditions

Essential Hypertension

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Bundang Seoul University Hospital

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: after 6 months of prescription for S-Amlodipine compared to baseline

Central Contacts

Yoojin Kim

CONTACT

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

Data from ClinicalTrials.gov

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