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
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>
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- 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.
- 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