Overview

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

Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
All
Summary
In this study, we will assess the change of extended renin-angiotensin system including serum ACE-2 and angiotensin(1-7) levels and subclinical atherosclerosis after using fimasartan (an ARB), compared to amlodipine in hypertensive patients with T2DM.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seoul National University Bundang Hospital
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