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Essential,HypertensionPhase 4FASTNCT02495324

Fimasartan Achieving SBP Target (FAST) Study

A Phase 4 study testing Fimasartan, Valsartan and Olmesartan medoxomil in people with Essential,Hypertension, run by Boryung Pharmaceutical Co., Ltd at 8 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of Fimasartan compared to Valsartan and Olmesartan(reference group) in patients with mild to moderate essential hypertension. Patients have 2 weeks of placebo run-in and wash out period, 2 weeks of taking required dose and 4 weeks of taking double dose. Read more about this study

Who is it for?
Ages 19 to 70 years
Conditions the study is for
Essential,Hypertension
What is being tested?
Fimasartan, Valsartan and Olmesartan medoxomil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
369 participants
Where
8 sitesSouth Korea
Study dates
Jun 2015to May 2017
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 19 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who voluntarily signed informed consent for participating in this clinical trial
  • Male and female between 19 and 70 years old
  • Subjects whose mean sitting SBP(siSBP) of 3 measurements is above 140mmHg at visit 2 with mild to moderate essential hypertension (Subjects who have not taken anti-hypertensive drugs within 3 months should have mean siSBP above 140mmHg at visit 1)
  • Subject who can understand the trial procedures and be willing to cooperate the trial

Who cannot join

  • Severe hypertension patients with mean siSBP ≥ 180mmHg or siDBP ≥110mmHg at the assessment of Screening visit(Visit1) and Baseline visit (Visit2).
  • Patients whose difference between maximum and minimum among 3 times of blood pressure measurement is over 20mmHg(siSBP) or 10mmHg(siDBP) at visit1 and visit2.
  • Patients whose medication compliance is under 70% at visit 2.
  • Secondary hypertension patients, but not limited to the following diseases (example: renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, etc).
  • Patients who have postural hypotension with manifestation.
  • Subjects with severe insulin-dependent Diabetes Mellitus(DM) or uncontrolled DM(HbA1c > 9% at screening visit, modified dosage of an oral hypoglycemic agent within 12 weeks prior to screening visit, or currently use of active insulin treatment).
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  • History of malignant tumor including leukemia and lymphoma in the past 5 years.
  • Subjects with chronic inflammatory disease requiring an chronic anti-inflammatory therapy, past or current medical history with wasting disease, autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus) or connective tissue disease.
  • Medical history with hypersensitivity to angiotensin II antagonist.
  • Clinically significant renal and liver disorders such as dialysis, cirrhosis, biliary obstruction, cholestasis and liver failure. Patients who have below abnormality in the laboratory results at screening visit.
  • Creatinine clearance(Cockroft-Gault)<30mL/min
  • ALT, AST ≥ 2 times upper normal limit
  • Clinically significant hypokalemia(K<3.5mmol/L) or hyperkalemia(K>5.5mmol/L)
  • Subjects have history of any of the followings within the past 6 months or determined clinically significant by investigators.
  • Severe heart disease (Heart failure New York Heart Association(NYHA) class 3 and 4), ischemic heart disease (angina pectoris, myocardial infarction), peripheral vascular disease, percutaneous transluminal coronary angioplasty or coronary artery bypass graft.
  • Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve stenosis, or mitral valve stenosis.
  • Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or any other clinical significant arrhythmia.
  • Severe cerebrovascular disorder(e.g.stroke, cerebral infarction or cerebral hemorrhage)
  • Subjects with known moderate or malignant retinosis in the past 6 months (e.g. retinal hemorrhage, visual disturbance or retinal microaneurysm)
  • Subjects with history of abusing drugs or alcohol within the past 2 years.
  • Pregnant women or lactating female.
  • Subjects with following surgical and internal disease that may affect absorption, distribution, metabolism or excretion of drugs and have conditions which include the following (but are not limited to): history of major gastrointestinal surgeries including gastrectomy, gastro-enterostomy or bowel resection, gastrointestinal bypass graft and stabling; current active gastritis, gastrointestinal and rectal bleeding, presence of active inflammatory bowel syndrome within the past 12 months.
  • Subjects with shock, depletion of body fluid or sodium ion not able to correct.
  • Subjects with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
  • Medical history with clinically significant hypersensitivity to any components or other drugs on the investigational product or additives(yellow4 and yellow 5).
  • Subjects planning pregnancy or childbearing potential who are not using effective contraceptive methods.
  • Subjects who are participating in another trial or took other investigational product within 12 weeks prior to screening visit.
  • Subjects with other reasons not specified above and ineligible to participate in this clinical trial at discretion of study investigators.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

South Korea8 sites

  • The Catholic University of Korea, Bucheon St.Mary's Hospital

    Bucheon-si, Gyeonggi-do, 420-717

  • The Catholic University of Korea, Daejeon St. Mary's Hospital

    Daejeon, Jung-gu/Daeheung-ro, 301-723

  • The Catholic University of Korea, Incheon St.Mary's Hospital

    Incheon, Bupyeong-gu, 403-720

  • The Catholic University of Korea, Seoul St.Mary's Hospital

    Seoul, Banpo-dong, Seocho-gu, 137-701

  • The Catholic University of Korea, St. Paul's Hospital

    Seoul, Dongdaemun-gu, 130-709

  • The Catholic University of Korea,Yeouido St.Mary's Hospital

    Seoul, Yeongdeungpo-gu, 150-713

  • The Catholic University of Korea, St.Vincent's Hospital.

    Suwon, Gyeonggi-do, 442-723

  • The Catholic University of Korea,Uijeongbu St.Mary's Hospital

    Uijeongbu-si, Gyeonggi-do, 480-717

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind, Active Control, 3-parallel Group, Forced Titration, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Fimasartan Versus Valsartan Monotherapy in Patients With Mild to Moderate Essential Hypertension

The purpose of this study is to evaluate the efficacy and safety of Fimasartan compared to Valsartan and Olmesartan(reference group) in patients with mild to moderate essential hypertension. Patients have 2 weeks of placebo run-in and wash out period, 2 weeks of taking required dose and 4 weeks of taking double dose.

Read the detailed description

A randomized, double-blind, active control, 3-parallel group comparison clinical study to evaluate the anti-hypertensive efficacy and safety of Fimasartan in patients with mild to moderate hypertension. Approximately 360 patients will be enrolled in 8 centers in South Korea. This study has planned 6 visits during 8 weeks.(2 weeks of placebo run-in and wash out, 2 weeks of treatment and 4 weeks of forced titration) All of the subjects who agreed to participate in this study and gave written informed consent voluntarily are assessed the inclusion and exclusion criteria and receive the investigational product(placebo) at screening visit. During more than 14 days of placebo run-in and wash out period, subjects have to stop the previous anti-hypertensive drug. After placebo run-in and wash out period, Subjects are assessed the final eligibility and started measuring ambulatory blood pressure for 24 hours. Subjects who determined to be appropriate for this study are allocated to experimental group(Fimasartan 60mg) or control group(Valsartan 80mg) or Reference group(Olmesartan 10mg) randomly at ratio 3:3:1.Subjects take their investigational products daily for 2 weeks and double dose for 4 weeks. The placebo period will be single-blinded and the treatment allocation in this study will be double-blinded.

Being tested
Placebo, Fimasartan, Valsartan, Olmesartan medoxomil
Medical subject headings
Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    2 weeks of placebo PO daily

  • FimasartanDrug

    Also called Kanarb Tab

    60mg 1 tab PO daily for 2 weeks and 120mg 1 tab PO daily for 4 weeks

  • ValsartanDrug

    Also called Diovan Tab

    80mg 1 tab PO daily for 2 weeks and 160mg 1 tab PO daily for 4 weeks

  • Olmesartan medoxomilDrug

    Also called Olmetec Tab

    10mg 1 tab PO daily for 2 weeks and 20mg 1 tab PO daily for 4 weeks

Study groups in NCT02495324
Study groupRoleWhat they receive
FimasartanExperimentalPlacebo daily for 2 weeks and Fimasartan 60mg daily for 2 weeks and 120mg daily for 4 weeks
Receives: Drug: Placebo; Drug: Fimasartan
ValsartanActive comparatorPlacebo daily for 2 weeks and Valsartan 80mg daily for 2 weeks and 160mg daily for 4 weeks
Receives: Drug: Placebo; Drug: Valsartan
Olmesartan medoxomilOtherReference group. Placebo daily for 2 weeks and Olmesartan 10mg daily for 2 weeks and 20mg daily for 4 weeks
Receives: Drug: Placebo; Drug: Olmesartan medoxomil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of sitting SBP from baseline after taking investigational products for 6 weeks.

    Measured: 6 weeks from baseline visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionMay 2017
  4. Study completionMay 2017

Resources

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
369 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02495324
Sponsor's protocol ID
BR-FVO-CT-401
Acronym
FAST
Status last verified
Jul 2017
First submitted
7 Jul 2015
Last updated
5 Jul 2017
Results posted
No
Data monitoring committee
No

Publications

  • Chung WB, Ihm SH, Jang SW, Her SH, Park CS, Lee JM, Chang K, Jeon DS, Yoo KD, Seung KB. Effect of Fimasartan versus Valsartan and Olmesartan on Office and Ambulatory Blood Pressure in Korean Patients with Mild-to-Moderate Essential Hypertension: A Randomized, Double-Blind, Active Control, Three-Parallel Group, Forced Titration, Multicenter, Phase IV Study (Fimasartan Achieving Systolic Blood Pressure Target (FAST) Study). Drug Des Devel Ther. 2020 Jan 23;14:347-360. doi: 10.2147/DDDT.S231293. eCollection 2020.

    PubMed 32158190

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fimasartan, Valsartan and Olmesartan medoxomil in people with Essential,Hypertension, run by Boryung Pharmaceutical Co., Ltd at 8 sites 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 4 inclusion and 28 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: finished, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of sitting SBP from baseline after taking investigational products for 6 weeks. (time frame: 6 weeks from baseline visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02495324, which also lists 1 linked publication.

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 5 Jul 2017.

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