Essential HypertensionPhase 1NCT01146938
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers
A Phase 1 study testing fimasartan in people with Essential Hypertension and Hepatic Impairment, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
To compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in hepatic impairment patients and healthy volunteers Read more about this study
- Who is it for?
- Ages 20 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension, Hepatic Impairment
- What is being tested?
- fimasartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Feb 2011
- Phase
- Phase 1
- 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 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- <Hepatic impairment patient>
- age: 20 - 64 years
- sex: male
- Child-Pugh score A or Child-Pugh score B
- body weight: greater than 55 kg
- written informed consent
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- <Healthy volunteer>
- age: 20 - 64 years
- sex: male
- body weight: greater than 55 kg
- written informed consent
Who cannot join
- <Hepatic impairment patient>
- portosystemic shunt surgery
- Child-Pugh score C
- creatinine clearance < 80mL/min
- ascites
- <Healthy volunteer>
Show all 9Show fewer
- AST(SGOT), ALT(SGPT) > 1.5 times of Upper Normal Range
- Total bilirubin > 1.5 times of Upper Normal Range
- positive drug or alcohol screening
Trial locations and contacts
1 site in 1 country.
About this study
To compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in hepatic impairment patients and healthy volunteers
- Conditions
- Essential Hypertension, Hepatic Impairment
- Being tested
- fimasartan
- Keywords
- fimasartan, hepatic impairment
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fimasartanDrug
single administration of fimasartan 120mg
fimasartanDrug
single administration of fimasartan 120mg
| Study group | Role | What they receive |
|---|---|---|
| hepatic impairment patients | Experimental | Hepatic impairment patients group Child-Pugh score A or Child-Pugh score B (not Child-Pugh score C) Receives: Drug: fimasartan |
| Healthy volunteers | Active comparator | healthy volunteers group Receives: Drug: fimasartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic characteristics of fimasartan
AUC, Cmax, Tmax, T1/2, CL/F of fimasartan
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe 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 1
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyungpook National University Hospital, Yonsei University
- Responsible party
- Sponsor
- Investigators
- Minsoo Park, PhD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146938
- Sponsor's protocol ID
- A657-BR-CT-112
- Status last verified
- Dec 2010
- First submitted
- 17 Jun 2010
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim CO, Lee HW, Oh ES, Seong SJ, Kim DY, Lee J, Ahn SH, Yoon YR, Cho CM, Park MS. Influence of hepatic dysfunction on the pharmacokinetics and safety of fimasartan. J Cardiovasc Pharmacol. 2013 Dec;62(6):524-9. doi: 10.1097/FJC.0000000000000010.
PubMed 24084213
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01146938
- Acronym / sponsor ID
- A657-BR-CT-112
- Conditions
- Essential Hypertension, Hepatic Impairment
- Keywords
- fimasartan, hepatic impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Kyungpook National University Hospital, Yonsei University
- Study start
- May 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 22 Jun 2010 (estimated)
- 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.
To compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in hepatic impairment patients and healthy volunteers
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hepatic impairment patients | Experimental | Drug: fimasartanHepatic impairment patients group Child-Pugh score A or Child-Pugh score B (not Child-Pugh score C) |
| Healthy volunteers | Active comparator | Drug: fimasartanhealthy volunteers group |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- <Hepatic impairment patient>
- age: 20 - 64 years
- sex: male
- Child-Pugh score A or Child-Pugh score B
- body weight: greater than 55 kg
Key exclusion criteria (9 listed)
- <Hepatic impairment patient>
- portosystemic shunt surgery
- Child-Pugh score C
- creatinine clearance < 80mL/min
- ascites
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 |
|---|---|---|
| fimasartansingle administration of fimasartan 120mg | Drug | hepatic impairment patients |
| fimasartansingle administration of fimasartan 120mg | Drug | Healthy volunteers |
Primary outcome
Pharmacokinetic characteristics of fimasartan
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 48h
AUC, Cmax, Tmax, T1/2, CL/F of fimasartan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
- Derived from this study: PubMed 24084213Kim CO, Lee HW, Oh ES, Seong SJ, Kim DY, Lee J, Ahn SH, Yoon YR, Cho CM, Park MS. Influence of hepatic dysfunction on the pharmacokinetics and safety of fimasartan. J Cardiovasc Pharmacol. 2013 Dec;62(6):524-9. doi: 10.1097/FJC.0000000000000010.
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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.
Minsoo Park, PhD principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing fimasartan in people with Essential Hypertension and Hepatic Impairment, 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 11 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: finished, as of the sponsor's last update on 5 Jan 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacokinetic characteristics of fimasartan (time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 48h). 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 NCT01146938, 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 Jan 2012.