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Essential HypertensionPhase 2FimasartanNCT00937651

Efficacy, Safety and Pharmacodynamic/Pharmacokinetic Study of Fimasartan (BR-A-657•K)

A Phase 2 study testing Fimasartan (BR-A-657•K) 20 mg, Fimasartan (BR-A-657•K) 60 mg and Fimasartan (BR-A-657•K) 180 mg in people with Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd.

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

Study objective: 1. To evaluate the antihypertensive efficacy, safety and tolerability of the drug after the oral administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential hypertension. 2. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Essential Hypertension
What is being tested?
Fimasartan (BR-A-657•K) 20 mg, Fimasartan (BR-A-657•K) 60 mg and Fimasartan (BR-A-657•K) 180 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
No sites listed yet
Study dates
Apr 2005to Jun 2006
Phase
Phase 2
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult men and women, aged 18 - 65
  • Patients with mild to moderate essential hypertension: On both screening and Day -1 visit, mean sitting DBP should be ≥ 95mmHg and ≤ 114mmHg, and ΔDBP on Day -14 and Day -1 should be within 7 mmHg
  • Patients who gave their consent to participate in this study and signed the written informed consent form
  • Patients who have understood the study, and been judged to be cooperative and able to participate in the study until the study completion date

Who cannot join

  • Women of childbearing potential who have not received the hysterectomy or men who are not willing to use birth control measures.
  • Patients whose sitting DBP is < 95mmHg or ≥ 115mmHg. Patients with severe hypertension whose SBP is ≥200mmHg
  • Patients with secondary hypertension
  • Patients with severe renal disease, gastrointestinal disorder, hematologic disorder, liver disease, etc. that can affect the absorption, distribution, metabolism and excretion of drugs
  • Patients with symptoms of orthostatic hypotension
  • Patients with severe insulin dependent diabetes or uncontrolled diabetes
Show all 16Show fewer
  • Patients who suffered myocardial infarction or serious coronary arterial disease over the past 6 months or patients with clinically significant congestive heart failure or valvular heart disease
  • Patients with consumption disease, autoimmune disease, or connective tissue disease
  • Patients with the history of type B hepatitis or type C hepatitis
  • Patients with HIV infection or hepatitis
  • Patients with clinically significant abnormal laboratory test findings
  • Patients on any drug treatment that might affect the blood pressure
  • Patients with allergy or contraindication to angiotensin II-receptor antagonists
  • Patients with current or suspected alcohol addiction or history of drug abuse
  • Patients whose mean weight lies out of the range of -15% ~ +35%, based on the Modified Metropolitan Life Insurance table
  • Patients who are not eligible as subjects of the study, as determined by the principal investigator or a sub-investigator

About this study

Official title: Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Antihypertensive Efficacy, Safety, Tolerability, and Pharmacodynamic/Pharmacokinetic Profiles After 4 Weeks of Oral Administration of Fimasartan(BR-A-657) at 20-180mg in Patients With Essential Hypertension

Study objective:

  1. To evaluate the antihypertensive efficacy, safety and tolerability of the drug after the oral administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential hypertension.
  2. To review the pharmacokinetic profile after the multiple administration and the pharmacodynamic profile regarding the renin-angiotensin system, after the oral administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential hypertension.
  3. To determine the dose for the clinical study at the next phase by analyzing the relationship between the antihypertensive efficacy and pharmacokinetic • pharmacodynamic results.
Read the detailed description

Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan (BR-A-657-K) 20mg ~ 480mg single dosing with healthy subjects, demonstrated that the Fimasartan (BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose.

A randomized, double-blind, placebo-controlled, parallel grouped, clinical study will be conducted to evaluate the antihypertensive efficacy and tolerability and to determine adequate antihypertensive dosage of Fimasartan(BR-A-657-K) in patients with mild to moderate essential hypertension.

Approximately 60 patients will be enrolled over 12 months in Seoul National University Hospital.

After 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 5 groups. Subjects will take test drug/placebo for 28 days of treatment period. If subjects take any antihypertensive medications before screening, the subjects will have 1 week of wash-out period.

Group I : Placebo, Group II : Fimasartan 20 mg, Group III: Fimasartan 60 mg, Group IV : Fimasartan 180 mg

Being tested
Placebo, Fimasartan (BR-A-657•K) 20 mg, Fimasartan (BR-A-657•K) 60 mg, Fimasartan (BR-A-657•K) 180 mg
Keywords
Fimasartan, Essential Hypertension
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

    Placebo

  • Fimasartan (BR-A-657•K) 20 mgDrug

    Also called Fimasartan

    Fimasartan 20 mg, 1 tablet + placebo, 2 tablets

  • Fimasartan (BR-A-657•K) 60 mgDrug

    Also called Fimasartan

    Fimasartan 20 mg, 1 tablet + 40 mg, 1 tablet + placebo 1 tablet

  • Fimasartan (BR-A-657•K) 180 mgDrug

    Also called Fimasartan

    Fimasartan 20 mg, 1 tablet + 80 mg, 1 tablet + 80 mg 1 tablet

Study groups in NCT00937651
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo, 3 tablets
Receives: Drug: Placebo
BR-A-657•K 20 mg groupActive comparatorFimasartan 20 mg, 1 tablet + placebo, 2 tablets
Receives: Drug: Fimasartan (BR-A-657•K) 20 mg
BR-A-657•K 60 mg groupActive comparatorFimasartan 20 mg, 1 tablet + 40 mg, 1 tablet + placebo 1 tablet
Receives: Drug: Fimasartan (BR-A-657•K) 60 mg
BR-A-657•K 180 mg groupActive comparatorFimasartan 20 mg, 1 tablet + 80 mg, 1 tablet + 80 mg 1 tablet
Receives: Drug: Fimasartan (BR-A-657•K) 180 mg

What is being measured

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

  1. the level of sitting diastolic blood pressure reduction

    Measured: Day -1 vs Day 27

Secondary outcomes (1)

  1. the level of sitting systolic blood pressure reduction, mean blood pressure (MBP), 24-hr day-time, night-time SBP and DBP, T/P ratio based on the 24-hr Ambulatory Blood Pressure Monitoring

    Measured: Day -1 vs Day 27

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 2009 (estimated)
  2. Study startApr 2005
  3. Primary completionJun 2006
  4. Study completionJun 2006

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00937651
Sponsor's protocol ID
A657-BR-CT-201
Acronym
Fimasartan
Status last verified
Jul 2009
First submitted
10 Jul 2009
Last updated
13 Jul 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Lee H, Yang HM, Lee HY, Kim JJ, Choi DJ, Seung KB, Jeon ES, Ha JW, Rim SJ, Park JB, Shin JH, Oh BH. Efficacy and tolerability of once-daily oral fimasartan 20 to 240 mg/d in Korean Patients with hypertension: findings from Two Phase II, randomized, double-blind, placebo-controlled studies. Clin Ther. 2012 Jun;34(6):1273-89. doi: 10.1016/j.clinthera.2012.04.021. Epub 2012 May 17.

    PubMed 22608107

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fimasartan (BR-A-657•K) 20 mg, Fimasartan (BR-A-657•K) 60 mg and Fimasartan (BR-A-657•K) 180 mg in people with Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd.

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 16 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 13 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 level of sitting diastolic blood pressure reduction (time frame: Day -1 vs Day 27). 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 NCT00937651, 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 13 Jul 2009.

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