Effect of Fimasartan on Extended RAS and Vascular Functions in Patients With Type 2 Diabetes and Hypertension
NCT ID: NCT05173025
Last Updated: 2023-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
42 participants
INTERVENTIONAL
2018-01-01
2023-12-31
Brief Summary
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Detailed Description
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Recent studies proved that fimasartan, one of the ARBs, stabilizes the activity of renin-angiotensin system. However, understanding the change in concentration of serum ACE, ACE-2, angiotensin(1-7), and angiotensin-II should help clinicians select more appropriate drug between ACE inhibitors and ARBs with clear evidence. Moreover, since RAS antagonists are the first-line drugs for antihypertensive therapy in patients with T2DM, it is meaningful to understand the change of RAS-related factors in serum after using the drugs.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fimasartan
\- Fimasartan group: Fimasartan, 60 mg once a day, oral administration
Fimasartan
\- Fimasartan group: fimasartan, 60 mg once a day, oral administration
Amlodipine
\- Comparator group: Amlodipine, 5 mg once a day, oral administration
Fimasartan
\- Fimasartan group: fimasartan, 60 mg once a day, oral administration
Interventions
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Fimasartan
\- Fimasartan group: fimasartan, 60 mg once a day, oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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Soo Lim
Professor
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B-1606-351-003
Identifier Type: -
Identifier Source: org_study_id
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