Evaluating blood pressure control in patients with essential hypertension
S-amlodipine in Essential HypertensIon and Assessment of Blood Pressure Targets Achievement According to 2022 KSH(Korean Society of Hypertension) Guidelines (SHIFT)
This study is testing how well S-amlodipine helps adults with high blood pressure reach their target levels after 6 months, and whether using it alone or with other medications works better and is safe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Hanlim Pharm. Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT06130124 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the percentage of patients with essential hypertension who achieve target blood pressure levels after 6 months of treatment with S-amlodipine, following the 2022 hypertension treatment guidelines. It will also compare the efficacy of monotherapy versus combination therapy in lowering blood pressure and evaluate the safety of the treatment by monitoring adverse events, including peripheral edema and headaches. The study will involve adults diagnosed with essential hypertension who are currently on antihypertensive medication.
Who should consider this trial
Good fit: Ideal candidates are adults over 19 years old diagnosed with essential hypertension who are currently receiving antihypertensive treatment.
Not a fit: Patients with contraindications to the study drug or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help improve blood pressure management strategies for patients with essential hypertension.
How similar studies have performed: Other studies have shown success in evaluating blood pressure management strategies, making this approach relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seongnam-si, Gyeonggi-do
- Bundang Seoul University Hospital — Seongnam-si, Gyeonggi-do, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Yoojin Kim
- Email: dec11@hanlim.com
- Phone: 82-2-3489-6192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.