HypertensionPhase 2NCT02222480
A Clinical Trial to Evaluate Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan/Hydrochlorothiazide
A Phase 2 study testing Fimasartan and Hydrochlorothiazide in people with Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in Combination with Hydrochlorothiazide in Patients with Mild to Moderate Hypertension Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Fimasartan and Hydrochlorothiazide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Jun 2015
- Phase
- Phase 2
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects of no childbearing potential 19-70 years of age
- Mean clinic-measured sitting DBP (siDBP) of 90-109 mmHg and mean clinic-measured sitting SBP (siSBP) of 140-179 mmHg after a ≥1-week washout of prior antihypertensive medications (no wash-out is needed for those not on any antihypertensive medications) with a difference of ≤10 mmHg in sitting DBP between before and after run-in
- Subjects who agree to participate in this study and give written informed consent
- Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study
Who cannot join
- Severe hypertension, i.e., mean siDBP ≥110 mmHg or mean siSBP ≥180 mmHg
- Orthostatic hypotension with clinically significant signs or symptoms
- Secondary hypertension
- Not able to stop administration other antihypertensive medications than the study drugs (i.e., fimasartan and hydrochlorothiazide) throughout the entire study period
- Clinically significant abnormal laboratory test results, e.g., serum creatinine >1.5 times upper limit of normal, AST, ALT > 2 times upper limit of normal
- Conditions that may affect to absorption, distribution, metabolism, and excretion for the study drugs
Show all 20Show fewer
- Severe insulin-dependent or uncontrolled diabetes mellitus (HbA1c >9%, increased dose of an oral hypoglycemic agent within 12 weeks before screening, or active insulin treatment at screening)
- Severe cardiovascular diseases within 6 months of screening including ischemic heart disease, peripheral vascular disease, significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia, hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease, severe cerebrovascular disease
- History of percutaneous transluminal coronary angiography or coronary artery bypass graft
- Chronic debilitating disease, autoimmune disease, connective tissue disease
- Positive on serum hepatitis B surface antigen, anti-hepatitis C virus antibody, or anti-HIV antibody
- History or evidence of alcohol or drug abuse within 2 years
- Known allergic reaction to any angiotensin receptor blockers
- Chronic inflammation disease requiring chronic anti-inflammation therapy
- Women of childbearing potential without any contraceptive measure or breast-feeding mother
- Prior participation in a clinical trial of any investigational products within 12 weeks from screening
- Serum potassium <3.5 mmol/L or >5.5 mmol/L at any time of the study period
- Depletion of sodium ion or body fluid, which cannot be corrected easily during the study period
- Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Considered unsuitable to participate in the study under the discretion of the principal investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in Combination With Hydrochlorothiazide in Patients With Mild to Moderate Hypertension
A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in Combination with Hydrochlorothiazide in Patients with Mild to Moderate Hypertension
- Conditions
- Hypertension
- Being tested
- Fimasartan, Hydrochlorothiazide, Placebo
- Keywords
- Patients, with mild, moderate, essential
- Medical subject headings
- Hypertension, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FimasartanDrug
HydrochlorothiazideDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Fimasartan 60 mg, Hydrochlorothiazide 12.5 mg | Experimental | Combination of Fimasartan/Hydrochlorothiazide 60/12.5mg Receives: Drug: Fimasartan; Drug: Hydrochlorothiazide |
| Fimasartan 60 mg, Hydrochlorothiazide 25 mg | Experimental | Combination of Fimasartan/Hydrochlorothiazide 60/25mg Receives: Drug: Fimasartan; Drug: Hydrochlorothiazide |
| Fimasartan 120 mg, Hydrochlorothiazide 12.5 mg | Experimental | Combination of Fimasartan/Hydrochlorothiazide 120/12.5mg Receives: Drug: Fimasartan; Drug: Hydrochlorothiazide |
| Fimasartan 120 mg, Hydrochlorothiazide 25 mg | Experimental | Combination of Fimasartan/Hydrochlorothiazide 120/25mg Receives: Drug: Fimasartan; Drug: Hydrochlorothiazide |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of treatment in 24-hour mean systolic blood pressure (SBP) using ambulatory blood pressure monitoring (ABPM)
Measured: from baseline to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2015
- Study completionJun 2015
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222480
- Sponsor's protocol ID
- BR-FHC-CT-201-BZ
- Status last verified
- Jun 2016
- First submitted
- 18 Aug 2014
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in Combination With Hydrochlorothiazide in Patients With Mild to Moderate Hypertension
- ClinicalTrials.gov ID
- NCT02222480
- Acronym / sponsor ID
- BR-FHC-CT-201-BZ
- Conditions
- Hypertension
- Keywords
- Patients, with mild, moderate, essential
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Study start
- Oct 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Aug 2014 (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.
A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in Combination with Hydrochlorothiazide in Patients with Mild to Moderate Hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Fimasartan 60 mg, Hydrochlorothiazide 12.5 mg | Experimental | Drug: Fimasartan, Drug: HydrochlorothiazideCombination of Fimasartan/Hydrochlorothiazide 60/12.5mg |
| Fimasartan 60 mg, Hydrochlorothiazide 25 mg | Experimental | Drug: Fimasartan, Drug: HydrochlorothiazideCombination of Fimasartan/Hydrochlorothiazide 60/25mg |
| Fimasartan 120 mg, Hydrochlorothiazide 12.5 mg | Experimental | Drug: Fimasartan, Drug: HydrochlorothiazideCombination of Fimasartan/Hydrochlorothiazide 120/12.5mg |
| Fimasartan 120 mg, Hydrochlorothiazide 25 mg | Experimental | Drug: Fimasartan, Drug: HydrochlorothiazideCombination of Fimasartan/Hydrochlorothiazide 120/25mg |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects of no childbearing potential 19-70 years of age
- Mean clinic-measured sitting DBP (siDBP) of 90-109 mmHg and mean clinic-measured sitting SBP (siSBP) of 140-179 mmHg after a ≥1-week washout of prior antihypertensive medications (no wash-out is needed for those not on any antihypertensive medications) with a difference of ≤10 mmHg in sitting DBP between before and after run-in
- Subjects who agree to participate in this study and give written informed consent
- Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study
Key exclusion criteria (20 listed)
- Severe hypertension, i.e., mean siDBP ≥110 mmHg or mean siSBP ≥180 mmHg
- Orthostatic hypotension with clinically significant signs or symptoms
- Secondary hypertension
- Not able to stop administration other antihypertensive medications than the study drugs (i.e., fimasartan and hydrochlorothiazide) throughout the entire study period
- Clinically significant abnormal laboratory test results, e.g., serum creatinine >1.5 times upper limit of normal, AST, ALT > 2 times upper limit of normal
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 |
|---|---|---|
| Fimasartan | Drug | Fimasartan 120 mg, Hydrochlorothiazide 12.5 mg, Fimasartan 120 mg, Hydrochlorothiazide 25 mg, Fimasartan 60 mg, Hydrochlorothiazide 12.5 mg, Fimasartan 60 mg, Hydrochlorothiazide 25 mg |
| Hydrochlorothiazide | Drug | Fimasartan 120 mg, Hydrochlorothiazide 12.5 mg, Fimasartan 120 mg, Hydrochlorothiazide 25 mg, Fimasartan 60 mg, Hydrochlorothiazide 12.5 mg, Fimasartan 60 mg, Hydrochlorothiazide 25 mg |
| Placebo | Drug | Placebo |
Primary outcome
Change of treatment in 24-hour mean systolic blood pressure (SBP) using ambulatory blood pressure monitoring (ABPM)
Time frame: from baseline to 2 weeks
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 1 Jul 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.
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 2 study testing Fimasartan and Hydrochlorothiazide in people with 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 20 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 1 Jul 2016. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change of treatment in 24-hour mean systolic blood pressure (SBP) using ambulatory blood pressure monitoring (ABPM) (time frame: from baseline to 2 weeks). 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 1 Jul 2016.