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

NCT05173025 | Unknown Phase 4 DMC

• 1 other identifier: B-1606-351-003
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Atherosclerosis; Diabetes Mellitus, Type 2; Renin Hypertension

Outcome Measures

Primary Outcomes (1)

• Angiotensin(1-7)

  Changes of serum angiotensin(1-7) at week 12 from baseline

  12 weeks

Secondary Outcomes (9)

• Blood pressure

  12 weeks

• ACE-2

  12 weeks

• ACE

  12 weeks

• Renin

  12 weeks

• angiotensin

  12 weeks

Study Arms (2)

Fimasartan

EXPERIMENTAL

\- Fimasartan group: Fimasartan, 60 mg once a day, oral administration

Drug: Fimasartan

Amlodipine

ACTIVE COMPARATOR

\- Comparator group: Amlodipine, 5 mg once a day, oral administration

Drug: Fimasartan

Interventions

Fimasartan DRUG

\- Fimasartan group: fimasartan, 60 mg once a day, oral administration

Also known as: Kanarb

Amlodipine; Fimasartan

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Hypertension; Atherosclerosis; Diabetes Mellitus, Type 2

Interventions

fimasartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Soo Lim, MD, PhD

CONTACT

01097662706; limsoo@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: December 29, 2021
• Study Start: January 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)