Essential HypertensionPhase 1NCT01289899
Fimasartan (BR-A-657) Multiple Oral Dose in Healthy Subjects
A Phase 1 study testing BR-A-657 in people with Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd.
Trial summary
The objective of this study is to determine the safety and tolerability and to determine the Pharmacokinetic and Pharmacodynamic(PK/PD) of ascending multiple oral dose of BR-A-657 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- BR-A-657
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Feb 2004
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male of 18-55 years old
- BMI 19-29kg/m2
- subjects in good health
- subjects with written informed consent
Who cannot join
- subjects with multiple drug allergy or allergy to ARB
- subjects with medication that affect drug absorption or elimination within 30days.
- subjects with orthostatic hypotension of >20mmHg decrease of sbp
- subjects with history of neurologic, liver, renal, GI, CV, psychological or other major disorder
About this study
Official title: BR-A-657, A Phase 1, Double-blind, Placebo-controlled, Ascending Multiple Oral Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects
The objective of this study is to determine the safety and tolerability and to determine the Pharmacokinetic and Pharmacodynamic(PK/PD) of ascending multiple oral dose of BR-A-657 in healthy male subjects.
Read the detailed description
BR-A-657 120, 360, or placebo were administered once daily for 7days to 16 healthy male subjects.
Pharmacokinetic and Pharmacodynamic(PK/PD) parameters were monitored at pre-specified times from each subjects.
PK parameters: Area Under the Curve(AUC), Cmax, half-life, etc. PD parameters: Aldosterone, Plasma renin activity, Angiotensin I, Angiotensin II Adverse events are reported.
- Conditions
- Essential Hypertension
- Being tested
- BR-A-657
- Keywords
- BR-A-657, Fimasartan, multiple-dose, pharmacokinetic, pharmacodynamic, safety
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR-A-657Drug
Also called Fimasartan
120, 360mg or placebo 7days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | BR-A-657 120mg or placebo Receives: Drug: BR-A-657 |
| Arm B | Experimental | BR-A-657 360mg or placebo Receives: Drug: BR-A-657 |
What is being measured
The primary outcome is the main question the study is designed to answer.
No of subjects with Adverse events(AE) from each observations
- AE reporting: Day 1: Predose, 3 \& 12h, Days 2~7: Predose, Days 8,9: Once daily, 5~7days post final dose
- Vital signs: Day 1: Predose, 0.5,1,2,4,8,12,24h,Days 3~6: Predose Day 7: Predose, 0.5,1,2,4,8,12,24,48h, 5~7days post final dose
- ECG: Days 1 \& 7: Predose, 2, 4, 8 \& 24h, Day 4: Predose, 5~7days post final dose
- Laboratory examination: Days 1 \& 4: Predose, Day 7: Predose \& 24h, 5~7days post final dose
- Physical examination: predose, 5~7days post final dose
- Body weight: predose, Days 4 \& 8
Measured: up to 5~7days post final(7th) dose
Secondary outcomes (5)
Area under the plasma concentration time curve (AUC)
Measured: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
Maximum observed plasma concentration (Cmax).
Measured: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
parent plasma terminal elimination half life (t½)
Measured: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
Apparent total plasma clearance (CL/F)
Measured: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
Accumulation ratio (RA)
RA1=Accumulation ratio based on AUCinf
RA2=Accumulation ratio based on Cmax
Measured: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startJan 2004
- Primary completionFeb 2004
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Investigators
- E Engmann, MB ChB, Principal investigator, Covance Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289899
- Sponsor's protocol ID
- 2290/9
- Status last verified
- Feb 2011
- First submitted
- 14 Dec 2010
- Last updated
- 4 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BR-A-657, A Phase 1, Double-blind, Placebo-controlled, Ascending Multiple Oral Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01289899
- Acronym / sponsor ID
- 2290/9
- Conditions
- Essential Hypertension
- Keywords
- BR-A-657, Fimasartan, multiple-dose, pharmacokinetic, pharmacodynamic, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- Jan 2004
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 4 Feb 2011 (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.
The objective of this study is to determine the safety and tolerability and to determine the Pharmacokinetic and Pharmacodynamic(PK/PD) of ascending multiple oral dose of BR-A-657 in healthy male subjects.
Detailed description
BR-A-657 120, 360, or placebo were administered once daily for 7days to 16 healthy male subjects.
Pharmacokinetic and Pharmacodynamic(PK/PD) parameters were monitored at pre-specified times from each subjects.
PK parameters: Area Under the Curve(AUC), Cmax, half-life, etc. PD parameters: Aldosterone, Plasma renin activity, Angiotensin I, Angiotensin II Adverse events are reported.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: BR-A-657BR-A-657 120mg or placebo |
| Arm B | Experimental | Drug: BR-A-657BR-A-657 360mg or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- male of 18-55 years old
- BMI 19-29kg/m2
- subjects in good health
- subjects with written informed consent
Key exclusion criteria (4 listed)
- subjects with multiple drug allergy or allergy to ARB
- subjects with medication that affect drug absorption or elimination within 30days.
- subjects with orthostatic hypotension of >20mmHg decrease of sbp
- subjects with history of neurologic, liver, renal, GI, CV, psychological or other major disorder
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 |
|---|---|---|
| BR-A-657Also: Fimasartan120, 360mg or placebo 7days | Drug | Arm A, Arm B |
Primary outcome
No of subjects with Adverse events(AE) from each observations
Time frame: up to 5~7days post final(7th) dose
1. AE reporting: Day 1: Predose, 3 \& 12h, Days 2~7: Predose, Days 8,9: Once daily, 5~7days post final dose 2. Vital signs: Day 1: Predose, 0.5,1,2,4,8,12,24h,Days 3~6: Predose Day 7: Predose, 0.5,1,2,4,8,12,24,48h, 5~7days post final dose 3. ECG: Days 1 \& 7: Predose, 2, 4, 8 \& 24h, Day 4: Predose, 5~7days post final dose 4. Laboratory examination: Days 1 \& 4: Predose, Day 7: Predose \& 24h, 5~7days post final dose 5. Physical examination: predose, 5~7days post final dose 6. Body weight: predose, Days 4 \& 8
5 secondary outcomes
Area under the plasma concentration time curve (AUC)
Time frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
Maximum observed plasma concentration (Cmax).
Time frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
parent plasma terminal elimination half life (t½)
Time frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
Apparent total plasma clearance (CL/F)
Time frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
Accumulation ratio (RA)
Time frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
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 4 Feb 2011.
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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.
E Engmann, MB ChB principal investigator
Covance Clinical Research Unit
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BR-A-657 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 4 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 4 Feb 2011. 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?
No of subjects with Adverse events(AE) from each observations (time frame: up to 5~7days post final(7th) dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2011.