Effect of Fimasartan on Blood Pressure and Vascular Health in Diabetic Patients
Effect of Fimasartan or Amlodipine on Extended Renin-angiotensin System in Patients With Type 2 Diabetes and Hypertension
This study is testing if fimasartan can lower blood pressure and improve blood vessel health in people with type 2 diabetes and high blood pressure compared to another medication called amlodipine.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 1 site (Seongnam, Gyeonggi) |
| Trial ID | NCT05173025 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of fimasartan, an angiotensin receptor blocker (ARB), on the renin-angiotensin system and vascular functions in patients with type 2 diabetes and hypertension. Participants will be compared to those receiving amlodipine to assess changes in serum levels of ACE-2 and angiotensin(1-7), as well as subclinical atherosclerosis. The goal is to provide clearer evidence for clinicians in selecting appropriate antihypertensive therapies for diabetic patients. The study is designed for individuals aged 30 and older who meet specific blood pressure and HbA1c criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 and older with type 2 diabetes and hypertension meeting specific blood pressure and HbA1c levels.
Not a fit: Patients with contraindications to fimasartan or amlodipine, or those with recent cardiovascular events, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of hypertension and vascular health in patients with type 2 diabetes.
How similar studies have performed: Previous studies have shown success with ARBs in managing diabetic complications, indicating a promising approach in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 30 years old * Type 2 diabetes by American Diabetes Association criteria * HbA1c: 6.5% ≤ - \< 10.0% * Systolic blood pressure: 140 ≤ - \< 180 mmHg or Diastolic blood pressure: 85 ≤ - \< 110 mmHg * Statin (-) or no change in low to moderate intensity statin \[14\] dose in recent 3 months Exclusion Criteria: * Contraindication of fimasartan or amlodipine * History of RAS inhibitors (ACE inhibitors or ARBs) or calcium channel blockers in the previous 3 months * Pregnant women, women with potential of pregnancy not using adequate contraception method as evaluated by the investigator, lactating women * Type 1 diabetes or diabetes secondary to chronic pancreatitis or to pancreatectomy * Confirmed cardiovascular disease (acute coronary syndrome, stroke, or transient ischemic attack) within 3 months of screening * Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT \> 3-fold the upper limit of normal) * Chronic kidney disease (serum creatinine \> 2.0 mg/dL) * Hyperkalemia serum potassium \>5.0 mEq/L * Any previous cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) except thyroid cancer or carcinoma in situ
Where this trial is running
Seongnam, Gyeonggi
- Seoul National University Bundang Hospital — Seongnam, Gyeonggi, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Soo Lim, MD, PhD
- Email: limsoo@snu.ac.kr
- Phone: 01097662706
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.