Essential HypertensionPhase 1NCT00923533
A Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers
A Phase 1 study testing Fimasartan and Hydrochlorothiazide in people with Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd.
Trial summary
To evaluate drug-drug interaction between fimasartan and hydrochlorothiazide. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Fimasartan and Hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Aug 2009
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age: 20 - 45 years
- sex: male
- body weight: greater than 55 kg
- written informed consent
Who cannot join
- known allergy to Fimasartan and hydrochlorothiazide
- existing cardiac or hematological diseases
- existing hepatic and renal diseases
- existing gastrointestinal diseases
- acute or chronic diseases which could affect drug absorption or metabolism
- history of any serious psychological disorder
Show all 9Show fewer
- positive drug or alcohol screening
- smokers of 10 or more cigarettes per day 3 month ago
- participation in a clinical trial during the last 2 months prior to the start of the study
About this study
Official title: An Open-label, Multiple-dosing, Crossover, and Parallel Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers
To evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.
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) 20 mg ~ 480 mg 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 open-labeled, multiple-dosing, crossover, parallel Clinical Study to Evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.
34 male healthy volunteers were enrolled during 2 months.
In part A, 240 mg of fimasartan per day was taken for 1 week. After 7 day washout period, 240 mg of fimasartan and 25mg of hydrochlorothiazide per day were taken for 1 week. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours at 7 day and 21 day.
In part B, 25 mg of hydrochlorothiazide per day was taken for 1 week. After 7 day washout period, 240 mg of fimasartan and 25mg of hydrochlorothiazide per day were taken for 1 week. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours at 7 day and 21 day.
- Conditions
- Essential Hypertension
- Being tested
- Fimasartan, Hydrochlorothiazide
- Keywords
- Fimasartan, Drug interaction
- 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
Fimasartan (7day) Fimasartan + Hydrochlorothiazide (7day)
HydrochlorothiazideDrug
Hydrochlorothiazide (7day) Fimasartan + Hydrochlorothiazide (7day)
| Study group | Role | What they receive |
|---|---|---|
| Part A | Active comparator | Fimasartan (7day) Fimasartan + Hydrochlorothiazide (7day) Receives: Drug: Fimasartan |
| Part B | Active comparator | Hydrochlorothiazide (7day) Hydrochlorothiazide + Fimasartan (7day) Receives: Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC, Cmax, Tmax, CL/F
Measured: 0, 0.5, 1, 1.5, 2, 2.5 3, 4, 6, 8, 12, 24 hours at 7 day and 21 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2009
- Study completionAug 2009
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923533
- Sponsor's protocol ID
- A657-BR-CT-103
- Status last verified
- Oct 2009
- First submitted
- 16 Jun 2009
- Last updated
- 8 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gu N, Kim BH, Lim KS, Kim SE, Nam WS, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. The effect of fimasartan, an angiotensin receptor type 1 blocker, on the pharmacokinetics and pharmacodynamics of warfarin in healthy Korean male volunteers: a one-sequence, two-period crossover clinical trial. Clin Ther. 2012 Jul;34(7):1592-600. doi: 10.1016/j.clinthera.2012.06.004. Epub 2012 Jun 22.
PubMed 22727611
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multiple-dosing, Crossover, and Parallel Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00923533
- Acronym / sponsor ID
- A657-BR-CT-103
- Conditions
- Essential Hypertension
- Keywords
- Fimasartan, Drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 18 Jun 2009 (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 evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.
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) 20 mg ~ 480 mg 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 open-labeled, multiple-dosing, crossover, parallel Clinical Study to Evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.
34 male healthy volunteers were enrolled during 2 months.
In part A, 240 mg of fimasartan per day was taken for 1 week. After 7 day washout period, 240 mg of fimasartan and 25mg of hydrochlorothiazide per day were taken for 1 week. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours at 7 day and 21 day.
In part B, 25 mg of hydrochlorothiazide per day was taken for 1 week. After 7 day washout period, 240 mg of fimasartan and 25mg of hydrochlorothiazide per day were taken for 1 week. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours at 7 day and 21 day.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Active comparator | Drug: FimasartanFimasartan (7day) Fimasartan + Hydrochlorothiazide (7day) |
| Part B | Active comparator | Drug: HydrochlorothiazideHydrochlorothiazide (7day) Hydrochlorothiazide + Fimasartan (7day) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age: 20 - 45 years
- sex: male
- body weight: greater than 55 kg
- written informed consent
Key exclusion criteria (9 listed)
- known allergy to Fimasartan and hydrochlorothiazide
- existing cardiac or hematological diseases
- existing hepatic and renal diseases
- existing gastrointestinal diseases
- acute or chronic diseases which could affect drug absorption or metabolism
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 |
|---|---|---|
| FimasartanFimasartan (7day) Fimasartan + Hydrochlorothiazide (7day) | Drug | Part A |
| HydrochlorothiazideHydrochlorothiazide (7day) Fimasartan + Hydrochlorothiazide (7day) | Drug | Part B |
Primary outcome
AUC, Cmax, Tmax, CL/F
Time frame: 0, 0.5, 1, 1.5, 2, 2.5 3, 4, 6, 8, 12, 24 hours at 7 day and 21 day
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 8 Oct 2009.
- Derived from this study: PubMed 22727611Gu N, Kim BH, Lim KS, Kim SE, Nam WS, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. The effect of fimasartan, an angiotensin receptor type 1 blocker, on the pharmacokinetics and pharmacodynamics of warfarin in healthy Korean male volunteers: a one-sequence, two-period crossover clinical trial. Clin Ther. 2012 Jul;34(7):1592-600. doi: 10.1016/j.clinthera.2012.06.004. Epub 2012 Jun 22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fimasartan and Hydrochlorothiazide 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 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 8 Oct 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. 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?
AUC, Cmax, Tmax, CL/F (time frame: 0, 0.5, 1, 1.5, 2, 2.5 3, 4, 6, 8, 12, 24 hours at 7 day and 21 day). 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 NCT00923533, 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 8 Oct 2009.