Essential HypertensionPhase 1NCT00938197
A Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers
A Phase 1 study testing Fimasartan and Amlodipine in people with Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
To evaluate the pharmacokinetic drug interaction after oral concurrent administration of fimasartan and amlodipine in healthy male volunteers Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Fimasartan and Amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age: 20 - 40 years
- sex: male
- body weight: greater than 55 kg
- written informed consent
Who cannot join
- known allergy to Fimasartan and amlodipine
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Multiple-dosing, and Crossover Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers
To evaluate the pharmacokinetic drug interaction after oral concurrent administration of fimasartan and amlodipine in healthy male volunteers
- Conditions
- Essential Hypertension
- Being tested
- Fimasartan, Amlodipine
- 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 (1d~7d) Amlodipine (12d~14d) Fimasartan + Amlodipine(15d~21d)
AmlodipineDrug
Amlodipine (1d~10d) Amlodipine (25d~27d) Fimasartan + Amlodipine(28d~34d)
| Study group | Role | What they receive |
|---|---|---|
| Part A | Active comparator | Not described Receives: Drug: Fimasartan |
| Part B | Active comparator | Not described Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCss, Cmax,ss, Tmax,ss, CLss/F
Measured: Part A: 0, 0.5, 1, 1.5, 2, 2.5 3, 4, 6, 8, 12, 24 hours at 7 day and 21 day Part B: 0, 1, 3, 4, 5, 6, 7, 8, 9, 11, 13, 15, 24 hours at 10 day and 34 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionAug 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938197
- Sponsor's protocol ID
- A657-BR-CT-107
- Status last verified
- Oct 2009
- First submitted
- 10 Jul 2009
- Last updated
- 8 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yi S, Kim TE, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Pharmacokinetic interaction of fimasartan, a new angiotensin II receptor antagonist, with amlodipine in healthy volunteers. J Cardiovasc Pharmacol. 2011 Jun;57(6):682-9. doi: 10.1097/FJC.0b013e31821795d0.
PubMed 21394036
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, and Crossover Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00938197
- Acronym / sponsor ID
- A657-BR-CT-107
- Conditions
- Essential Hypertension
- Keywords
- Fimasartan, Drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 Jul 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 the pharmacokinetic drug interaction after oral concurrent administration of fimasartan and amlodipine in healthy male volunteers
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Active comparator | Drug: Fimasartan |
| Part B | Active comparator | Drug: Amlodipine |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age: 20 - 40 years
- sex: male
- body weight: greater than 55 kg
- written informed consent
Key exclusion criteria (9 listed)
- known allergy to Fimasartan and amlodipine
- 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 (1d~7d) Amlodipine (12d~14d) Fimasartan + Amlodipine(15d~21d) | Drug | Part A |
| AmlodipineAmlodipine (1d~10d) Amlodipine (25d~27d) Fimasartan + Amlodipine(28d~34d) | Drug | Part B |
Primary outcome
AUCss, Cmax,ss, Tmax,ss, CLss/F
Time frame: Part A: 0, 0.5, 1, 1.5, 2, 2.5 3, 4, 6, 8, 12, 24 hours at 7 day and 21 day Part B: 0, 1, 3, 4, 5, 6, 7, 8, 9, 11, 13, 15, 24 hours at 10 day and 34 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 21394036Yi S, Kim TE, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Pharmacokinetic interaction of fimasartan, a new angiotensin II receptor antagonist, with amlodipine in healthy volunteers. J Cardiovasc Pharmacol. 2011 Jun;57(6):682-9. doi: 10.1097/FJC.0b013e31821795d0.
Related trials for Essential Hypertension
Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
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.
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 and Amlodipine in people with Essential Hypertension, 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 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.
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?
AUCss, Cmax,ss, Tmax,ss, CLss/F (time frame: Part A: 0, 0.5, 1, 1.5, 2, 2.5 3, 4, 6, 8, 12, 24 hours at 7 day and 21 day Part B: 0, 1, 3, 4, 5, 6, 7, 8, 9, 11, 13, 15, 24 hours at 10 day and 34 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 NCT00938197, 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.