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HypertensionPhase 3fimasartanNCT01672476

A Multicenter, Phase 3 Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan(BR-A-657∙K) 30mg Compared to Placebo in Patients With Mild to Moderate Essential Hypertension

A Phase 3 study testing Valsartan and Fimasartan in people with Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site 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

A Randomized, Double-Blind, Multicenter, phase III Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan (BR-A-657·K) 30mg Compared to Placebo in Patients with Mild to Moderate Essential Hypertension Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Hypertension
What is being tested?
Valsartan and Fimasartan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
293 participants
Where
1 siteSouth Korea
Study dates
Apr 2012to Apr 2013
Phase
Phase 3
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who agreed to participate in this clinical trial and submitted the written informed consent
  • Subjects aged 20 to 75 years
  • Essential hypertension patients who are measured more 90mmHg, less than 110mmHg of sitting diastolic blood pressure(SiDBP) at baseline(Day 0)
  • Subject who considered to understand this clinical trial, be cooperative,and able to be followed-up whole of the clinical trial period

Who cannot join

  • Severe hypertension patients: more 110mmHg of mean SiDBP and/or more 185mmHg of mean Sitting systolic blood pressure(SiSBP)
  • Patients with orthostatic hypotension who has sign and symptom
  • Patients with secondary hypertension
  • Patients who are measured the difference of mean blood pressure of one arm under SiDBP 10mmHg or SiSBP 20mmHg at screening and baseline visit
  • Patients who cannot stop administration of hypertension medication through the clinical trial period, and can take any other hypertension medication except investigational drugs
  • Patients with significant investigations-abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function(AST, ALT more 2 times than upper limit of normal), severe fatty liver disease needed medication
Show all 26Show fewer
  • Patients with clinically significant investigations in laboratory test of screening visit
  • Patients with surgical and medical disease that is able to be affect to absorption, distribution, metabolism and excretion
  • Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c>9, regimen change of oral hypoglycemic agent, using insulin)
  • Patients with severe heart disease, ischemic heart disease within 6 months, peripheral vascular disease, Percutaneous transluminal coronary angiography(PTCA), Coronary artery bypass graft(CABG)
  • Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
  • Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
  • Patients with severe cerebrovascular disease
  • Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous
  • Patients with known severe or malignancy retinopathy
  • Patients with hepatitis B or C or HIV positive reaction
  • Patients with the medical histories of malignant tumor within 5 years,except local basal cell carcinoma of the skin
  • Patients who have a story or evidence of alcohol or drug abuse within 2 years
  • Patients with history of allergic reaction to any angiotensin II antagonist
  • Patients with any chronic inflammation disease needed to chronic inflammation therapy
  • Childbearing and breast-feeding women
  • Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
  • Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial
  • Patients with significant investigations-Hypokalemia(Less than 3.5 mmol/L), Hyperkalemia(exceeded 5.5 mmol/L)
  • Patients with sodium ion or body fluid is deplated and not able to correct
  • Subject who are judged unsuitable to participate in this clinical trial by investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Double-Blind, Multicenter, Phase 3 Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan(BR-A-657∙K) 30mg Compared to Placebo in Patients With Mild to Moderate Essential Hypertension

A Randomized, Double-Blind, Multicenter, phase III Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan (BR-A-657·K) 30mg Compared to Placebo in Patients with Mild to Moderate Essential Hypertension

Read the detailed description

After subjects have signed informed consent voluntarily, when they are taking hypertension medication, they go through screening period for 7 days including wash-out period.

After screening and wash-out period, subjects take the placebo for 14 days (Maximum 21 days), and evaluate their suitability to Inclusion and Exclusion criteria.

Patients, who evaluated the proper subject for this clinical trial, are allocated to experimental group (Fimasartan 30mg) or Control group (Placebo group) or Reference group (Valsartan 80mg) randomly at a ratio 2:2:1 and their investigational drugs will be administered daily for the study period (8 weeks). Subjects visit their investigators twice during treatment period, when they take their investigational drugs for 4 weeks, and 8 weeks.

The placebo period will be single-blinded and the treatment allocation in this study will be double-blinded.

Conditions
Hypertension
Being tested
Placebo, Valsartan, Fimasartan
Keywords
Fimasartan
Medical subject headings
Hypertension

What participants receive

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

  • PlaceboDrug

    Placebo

  • ValsartanDrug

    Also called Diovan

    Valsartan 80mg

  • FimasartanDrug

    Also called Kanarb

    Fimasartan 30mg

Study groups in NCT01672476
Study groupRoleWhat they receive
PlaceboPlacebo comparator1 capsule/day of placebo will be orally administered for the study period (8 weeks)
Receives: Drug: Placebo
Valsartan 80mgActive comparator(As reference group) 80mg/day of Valsartan will be orally administered for the study period (8 weeks)
Receives: Drug: Valsartan
Fimasartan 30mgExperimental30mg/day of Fimasartan will be orally administered for the study period (8 weeks)
Receives: Drug: Fimasartan

What is being measured

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

  1. the difference of sitting DBP

    To compare the difference of sitting DBP between fimasartan 30mg group and placebo group

    Measured: After 8 weeks from baseline visit

Secondary outcomes (5)

  1. the difference of sitting DBP

    To compare the difference of sitting DBP between fimasartan 30mg group and valsartan 80mg group

    Measured: After 8 weeks from baseline visit

  2. the difference of SiDBP

    To compare the difference of SiDBP among fimasartan 30mg group, valsartan 80mg and placebo group

    Measured: After 4 weeks from baseline visit

  3. the difference of SiSBP

    To compare the difference of SiSBP among fimasartan 30mg group, valsartan 80mg and placebo group

    Measured: After 4 weeks and 8 weeks from baseline visit

  4. the ratio of responder(SiDBP<90mmHg or ΔSiDBP≥10mmHg)

    To compare the ratio of responder(SiDBP<90mmHg or ΔSiDBP≥10mmHg) among fimasartan 30mg group, valsartan 80mg and placebo group

    Measured: After 8 weeks from baseline visit

  5. the ratio of subjects who get normalized blood pressure(SiDBP<90mmHg & SiSBP<140mmHg)

    To compare the ratio of subjects who get normalized blood pressure(SiDBP<90mmHg \& SiSBP<140mmHg) among fimasartan 30mg group, valsartan 80mg and placebo group

    Measured: After 8 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 posted27 Aug 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionMar 2013
  4. Study completionApr 2013

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
293 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01672476
Sponsor's protocol ID
A657-BR-CT-L301
Acronym
fimasartan
Status last verified
Jun 2016
First submitted
20 Aug 2012
Last updated
1 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Youn JC, Ihm SH, Bae JH, Park SM, Jeon DW, Jung BC, Park TH, Lee NH, Song JM, Yoon YW, Shin ES, Sung KC, Jung IH, Pyun WB, Joo SJ, Park WJ, Shin JH, Kang SM. Efficacy and safety of 30-mg fimasartan for the treatment of patients with mild to moderate hypertension: an 8-week, multicenter, randomized, double-blind, phase III clinical study. Clin Ther. 2014 Oct 1;36(10):1412-21. doi: 10.1016/j.clinthera.2014.07.004. Epub 2014 Aug 3.

    PubMed 25092393

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Valsartan and Fimasartan in people with Hypertension, run by Boryung Pharmaceutical Co., Ltd 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 4 inclusion and 26 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 1 Jul 2016. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

the difference of sitting DBP (time frame: After 8 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 NCT01672476, 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 1 Jul 2016.

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fimasartan Clinical Trial NCT01672476 | AzTrials