HypertensionPhase 4NCT01736488
Clinical Study to Evaluate the Antihypertensive Efficacy and Changes of Neurohormonal Markers of Fimasartan and Atenolol With Exaggerated Blood Pressure Response During Exercise in Essential Hypertensive Patients
A Phase 4 study testing Fimasartan and Atenolol in people with Hypertension, run by Boryung Pharmaceutical Co., Ltd at 4 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the antihypertensive efficacy and changes of neurohormonal markers of fimasartan and atenolol with exaggerated blood pressure response during exercise in essential hypertensive patients. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Fimasartan and Atenolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Oct 2012to Jun 2016
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who agreed to participate in this clinical trial and submitted the written informed consent
- Subjects aged 20 to 75 years
- Essential hypertension patients who are measured more 140mmHg, less than 170mmHg of sitting systolic blood pressure(SiSBP) or more 90mmHg, less than 110mmHg of sitting diastolic blood pressure(SiDBP) at baseline(Day 0)
- men who are measured more 210mmHg, women who are measured more 190mmHg or increasing more than 50mmHg after exercise at baseline(Day 0)
- Subject who considered to understand this clinical trial, be cooperative,and able to be followed-up whole of the clinical trial period
Who cannot join
- Patients who are measured the difference of mean blood pressure of one arm under sitting diastolic blood pressure(SiDBP) 10mmHg or SiSBP 20mmHg at screening and baseline visit
- more 170mmHg of mean Sitting systolic blood pressure(SiSBP)or more 110mmHg of mean Sitting diastolic blood pressure(SiDBP) before exercise at baseline(Day 0)
- Patients with secondary hypertension
- Patients with orthostatic hypotension who has sign and symptom
- Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c>9, regimen change of oral hypoglycemic agent, using insulin)
- Patients with severe heart disease, ischemic heart disease within 6 months, peripheral vascular disease, Percutaneous transluminal coronary angiography(PTCA), Coronary artery bypass graft(CABG)
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- Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
- Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
- Patients with severe cerebrovascular disease
- Patients with known severe or malignancy retinopathy
- Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous
- Patients with significant investigations; abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function(AST, ALT more 2 times than upper limit of normal), severe fatty liver disease needed medication
- Patients with surgical and medical disease that is able to be affect to absorption, distribution, metabolism and excretion
- Patients who have a story or evidence of alcohol or drug abuse within 2 years
- Childbearing and breast-feeding women
- Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
- Patients with Bronchial Asthma
- Patients expected to live less than 1 year with tumor or chronic disease
- Patients with hepatitis B or C
- Patients with history of allergic reaction to any angiotensin II antagonist
- Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial
- Subject who are judged unsuitable to participate in this clinical trial by investigator
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Hallym University Medical Center
Anyang
Gachon University Gil Hospital
Incheon
Severance Hospital
Seoul, 120-752
Kangnam Severance Hospital
Seoul
About this study
Official title: A Randomized, Double-Blind, Phase IV Clinical Study to Evaluate the Antihypertensive Efficacy and Changes of Neurohormonal Markers of Fimasartan and Atenolol With Exaggerated Blood Pressure Response During Exercise in Essential Hypertensive Patients
The purpose of this study is to evaluate the antihypertensive efficacy and changes of neurohormonal markers of fimasartan and atenolol with exaggerated blood pressure response during exercise in essential hypertensive patients.
Read the detailed description
After subjects have signed informed consent voluntarily, when they are taking hypertension medication, they go through screening period for 7 days including wash-out period.
After screening and wash-out period, subjects take the placebo for 14 days (Maximum 21 days), and evaluate their suitability to Inclusion and Exclusion criteria.
Patients, who evaluated the proper subject for this clinical trial, are allocated to experimental group (Fimasartan 60mg) or Control group (Atenolol 50mg) randomly at a ratio 1:1 and their investigational drugs will be administered daily for the study period (8 weeks). Subjects visit their investigators twice during treatment period, when they take their investigational drugs for 4 weeks, and 8 weeks.
The placebo period will be single-blinded and the treatment allocation in this study will be double-blinded.
- Conditions
- Hypertension
- Being tested
- Fimasartan, Atenolol
- Keywords
- Hypertension, Antihypertensive efficacy, Neurohormonal markers, Blood Pressure Response, Exercise
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FimasartanDrug
Also called Kanarb
Fimasartan 60mg
AtenololDrug
Also called Tenolmin
Atenolol 50mg
| Study group | Role | What they receive |
|---|---|---|
| Fimasartan 60mg | Experimental | 60mg/day of Fimasartan will be oral administered for the study period (8 weeks) Receives: Drug: Fimasartan |
| Atenolol 50mg | Active comparator | 50mg/day of Atenolol will be oral administered for the study period (8 weeks) Receives: Drug: Atenolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of sitting Systolic Blood Pressure(SiSBP) between at the peak compared to at resting
To compare the difference of sitting Systolic Blood Pressure(SiSBP) at the peak compared to at resting between Fimasartan 60mg group and Atenolol 50mg group
Measured: After 8 weeks from baseline visit
Secondary outcomes (3)
The difference of sitting Diastolic Blood Pressure(SiDBP) at the peak compared to at resting
To compare the difference of sitting Diastolic Blood Pressure(SiDBP), Heart Rate, Neurohormonal markers at the peak compared to at resting between Fimasartan 60mg group and Atenolol 50mg group
Measured: After 8 weeks from baseline visit
The difference of sitting Systolic Blood Pressure(SiSBP) at each exercising stage compared to at resting
To compare the difference of sitting Systolic Blood Pressure(SiSBP), sitting Diastolic Blood Pressure(SiDBP), Heart Rate at each exercising stage and at recovery compared to at resting between Fimasartan 60mg group and Atenolol 50mg group
Measured: After 8 weeks from baseline visit
The difference of sitting Systolic Blood Pressure(SiSBP) among at resting, each exercising stage and recovery
To compare the difference of sitting Systolic Blood Pressure(SiSBP), sitting Diastolic Blood Pressure(SiDBP), Heart Rate, neurohormonal markers among at resting, each exercising stage and recovery between Fimasartan 60mg group and Atenolol 50mg group
Measured: After 8 weeks from baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Severance Hospital
- Responsible party
- Sponsor
- Investigators
- Jong Won Ha, PhD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736488
- Sponsor's protocol ID
- BR-FA-CT-401
- Status last verified
- Sep 2016
- First submitted
- 19 Nov 2012
- Last updated
- 23 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase IV Clinical Study to Evaluate the Antihypertensive Efficacy and Changes of Neurohormonal Markers of Fimasartan and Atenolol With Exaggerated Blood Pressure Response During Exercise in Essential Hypertensive Patients
- ClinicalTrials.gov ID
- NCT01736488
- Acronym / sponsor ID
- BR-FA-CT-401
- Conditions
- Hypertension
- Keywords
- Hypertension, Antihypertensive efficacy, Neurohormonal markers, Blood Pressure Response, Exercise
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Severance Hospital
- Study start
- Oct 2012
- Primary completion
- Jun 2016 (actual)
- First posted
- 29 Nov 2012 (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 purpose of this study is to evaluate the antihypertensive efficacy and changes of neurohormonal markers of fimasartan and atenolol with exaggerated blood pressure response during exercise in essential hypertensive patients.
Detailed description
After subjects have signed informed consent voluntarily, when they are taking hypertension medication, they go through screening period for 7 days including wash-out period.
After screening and wash-out period, subjects take the placebo for 14 days (Maximum 21 days), and evaluate their suitability to Inclusion and Exclusion criteria.
Patients, who evaluated the proper subject for this clinical trial, are allocated to experimental group (Fimasartan 60mg) or Control group (Atenolol 50mg) randomly at a ratio 1:1 and their investigational drugs will be administered daily for the study period (8 weeks). Subjects visit their investigators twice during treatment period, when they take their investigational drugs for 4 weeks, and 8 weeks.
The placebo period will be single-blinded and the treatment allocation in this study will be double-blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fimasartan 60mg | Experimental | Drug: Fimasartan60mg/day of Fimasartan will be oral administered for the study period (8 weeks) |
| Atenolol 50mg | Active comparator | Drug: Atenolol50mg/day of Atenolol will be oral administered for the study period (8 weeks) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who agreed to participate in this clinical trial and submitted the written informed consent
- Subjects aged 20 to 75 years
- Essential hypertension patients who are measured more 140mmHg, less than 170mmHg of sitting systolic blood pressure(SiSBP) or more 90mmHg, less than 110mmHg of sitting diastolic blood pressure(SiDBP) at baseline(Day 0)
- men who are measured more 210mmHg, women who are measured more 190mmHg or increasing more than 50mmHg after exercise at baseline(Day 0)
- Subject who considered to understand this clinical trial, be cooperative,and able to be followed-up whole of the clinical trial period
Key exclusion criteria (22 listed)
- Patients who are measured the difference of mean blood pressure of one arm under sitting diastolic blood pressure(SiDBP) 10mmHg or SiSBP 20mmHg at screening and baseline visit
- more 170mmHg of mean Sitting systolic blood pressure(SiSBP)or more 110mmHg of mean Sitting diastolic blood pressure(SiDBP) before exercise at baseline(Day 0)
- Patients with secondary hypertension
- Patients with orthostatic hypotension who has sign and symptom
- Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c>9, regimen change of oral hypoglycemic agent, using insulin)
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 |
|---|---|---|
| FimasartanAlso: KanarbFimasartan 60mg | Drug | Fimasartan 60mg |
| AtenololAlso: TenolminAtenolol 50mg | Drug | Atenolol 50mg |
Primary outcome
The difference of sitting Systolic Blood Pressure(SiSBP) between at the peak compared to at resting
Time frame: After 8 weeks from baseline visit
To compare the difference of sitting Systolic Blood Pressure(SiSBP) at the peak compared to at resting between Fimasartan 60mg group and Atenolol 50mg group
3 secondary outcomes
The difference of sitting Diastolic Blood Pressure(SiDBP) at the peak compared to at resting
Time frame: After 8 weeks from baseline visit
The difference of sitting Systolic Blood Pressure(SiSBP) at each exercising stage compared to at resting
Time frame: After 8 weeks from baseline visit
The difference of sitting Systolic Blood Pressure(SiSBP) among at resting, each exercising stage and recovery
Time frame: After 8 weeks from baseline visit
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 23 Sep 2016.
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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.
Jong Won Ha, PhD principal investigator
Yonsei University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fimasartan and Atenolol in people with Hypertension, run by Boryung Pharmaceutical Co., Ltd at 4 sites 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 5 inclusion and 22 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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The difference of sitting Systolic Blood Pressure(SiSBP) between at the peak compared to at resting (time frame: After 8 weeks from baseline visit). 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 23 Sep 2016.