Clinical trial NCT06130124: S-amlodipine in Essential HypertensIon and Assessment of Blood Pressure Targets Achievement
Official title: S-amlodipine in Essential HypertensIon and Assessment of Blood Pressure Targets Achievement According to 2022 KSH(Korean Society of Hypertension) Guidelines (SHIFT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Essential Hypertension
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-14
Enrollment: 5000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with essential hypertension who received Lodien Tab.

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: after 6 months of prescription for S-Amlodipine compared to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Bundang Seoul University Hospital
state: Gyeonggi-do
Study officials:
References: