Effect of Fimasartan on Extended RAS and Vascular Functions in Patients With Type 2 Diabetes and Hypertension

Launched by SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL · Dec 27, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called fimasartan on patients who have both high blood pressure (hypertension) and type 2 diabetes. The researchers want to see how fimasartan affects the body's renin-angiotensin system, which plays a role in blood pressure regulation, and whether it helps with early signs of blood vessel disease. They will compare the results of fimasartan to another medication called amlodipine.

To participate in this study, you need to be at least 30 years old, have type 2 diabetes, and have specific blood pressure readings. The trial is open to all genders. If you join the study, you will receive either fimasartan or amlodipine for treatment and will be monitored for changes in your health. It's important to note that there are certain health conditions and recent medication histories that may prevent you from participating, so it’s best to talk to your doctor to see if you qualify.

Gender

ALL

Eligibility 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