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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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06130124
Enrollment
5000
Registered
2023-11-14
Start date
2023-02-22
Completion date
2025-07-25
Last updated
2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

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.

Interventions

None listed

Sponsors

Hanlim Pharm. Co., Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 guidelinesafter 6 months of prescription for S-Amlodipine compared to baselineThe 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

Countries

South Korea

Contacts

Primary ContactYoojin Kim
dec11@hanlim.com82-2-3489-6192

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026