HypertensionPhase 4FAoRASNCT05173025
Effect of Fimasartan on Extended RAS and Vascular Functions in Patients With Type 2 Diabetes and Hypertension
A Phase 4 study testing Fimasartan in people with Hypertension and Atherosclerosis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Hypertension, Atherosclerosis, Diabetes Mellitus, Type 2
- What is being tested?
- Fimasartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2018to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Soo Lim, MD, PHD, 82-31-787-7035, limsoo@snu.ac.kr
Soo Lim, MD, PHD
About this study
Official title: Effect of Fimasartan or Amlodipine on Extended Renin-angiotensin System in Patients With Type 2 Diabetes and Hypertension
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.
Read the detailed description
Several clinical trials aimed at studying the benefits of RAS blockade in the diabetic complications. HOPE, RENAAL, IRMA2, IDNT, ONTARGET studies proved that ACE inhibitors or ARBs reduced the risk of diabetic complications.
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.
- Being tested
- Fimasartan
- Medical subject headings
- Hypertension, Atherosclerosis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FimasartanDrug
Also called Kanarb
- Fimasartan group: fimasartan, 60 mg once a day, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Fimasartan | Experimental | - Fimasartan group: Fimasartan, 60 mg once a day, oral administration Receives: Drug: Fimasartan |
| Amlodipine | Active comparator | - Comparator group: Amlodipine, 5 mg once a day, oral administration Receives: Drug: Fimasartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiotensin(1-7)
Changes of serum angiotensin(1-7) at week 12 from baseline
Measured: 12 weeks
Secondary outcomes (9)
Blood pressure
Change in blood pressure from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Measured: 12 weeks
ACE-2
Change in ACE-2 from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Measured: 12 weeks
ACE
Change in ACE from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Measured: 12 weeks
Renin
Change in renin from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Measured: 12 weeks
angiotensin
Change in angiotensin from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Measured: 12 weeks
atherosclerosis
Change in atherosclerosis from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Measured: 12 weeks
Muscle mass
Change in muscle mass from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Measured: 12 weeks
Fat mass
Change in fat mass from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Measured: 12 weeks
HbA1c
Change in HbA1c from baseline to week 12
Change in blood pressure from baseline to week 24
Change in blood pressure from baseline to week 24
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 Jan 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173025
- Sponsor's protocol ID
- B-1606-351-003
- Acronym
- FAoRAS
- Status last verified
- Aug 2023
- First submitted
- 27 Dec 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fimasartan or Amlodipine on Extended Renin-angiotensin System in Patients With Type 2 Diabetes and Hypertension
- ClinicalTrials.gov ID
- NCT05173025
- Acronym / sponsor ID
- FAoRAS / B-1606-351-003
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Several clinical trials aimed at studying the benefits of RAS blockade in the diabetic complications. HOPE, RENAAL, IRMA2, IDNT, ONTARGET studies proved that ACE inhibitors or ARBs reduced the risk of diabetic complications.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fimasartan | Experimental | Drug: Fimasartan- Fimasartan group: Fimasartan, 60 mg once a day, oral administration |
| Amlodipine | Active comparator | Drug: Fimasartan- Comparator group: Amlodipine, 5 mg once a day, oral administration |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FimasartanAlso: Kanarb- Fimasartan group: fimasartan, 60 mg once a day, oral administration | Drug | Amlodipine, Fimasartan |
Primary outcome
Angiotensin(1-7)
Time frame: 12 weeks
Changes of serum angiotensin(1-7) at week 12 from baseline
9 secondary outcomes
Blood pressure
Time frame: 12 weeks
ACE-2
Time frame: 12 weeks
ACE
Time frame: 12 weeks
Renin
Time frame: 12 weeks
angiotensin
Time frame: 12 weeks
atherosclerosis
Time frame: 12 weeks
Muscle mass
Time frame: 12 weeks
Fat mass
Time frame: 12 weeks
HbA1c
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fimasartan in people with Hypertension and Atherosclerosis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soo Lim, MD, PhD (01097662706, limsoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angiotensin(1-7) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.