HypertensionPhase 4NCT02958631
Comparison of Blood Pressure Lowering Effect Between Fimasartan and Losartan
A Phase 4 study testing Fimasartan and Losartan in people with Hypertension, run by Chuncheon Sacred Heart Hospital.
Trial summary
Comparison of blood pressure lowering effect between Fimasartan and Losartan in the hypertensive patient during night and early morning time Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Fimasartan and Losartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Apr 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject don't have Anti-hypertensive drug or who stop Anti-hypertensive drug during 2 weeks
- Office BP: over siSBP 140mmHg or si DBP 90mmHg
- 24hr ABPM: SBP 130mmHg or DBP 80mmHg (24 hour Average)
Who cannot join
- Pregnant, trying to become pregnant or breast feeding
- Subject has Secondary Hypertension
- White coat Blood Pressure (Normal result of 24 hour ABPM)
About this study
Official title: Comparison of Blood Pressure Lowering Effect Between Fimasartan and Losartan in the Hypertensive Patient During Night and Early Morning Time
Comparison of blood pressure lowering effect between Fimasartan and Losartan in the hypertensive patient during night and early morning time
- Conditions
- Hypertension
- Being tested
- Fimasartan, Losartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FimasartanDrug
Also called Kanarb
LosartanDrug
Also called Cozaar
| Study group | Role | What they receive |
|---|---|---|
| Fimasartan | Experimental | Fimasartan 60mg, QD Receives: Drug: Fimasartan |
| Losartan | Active comparator | Losartan 50mg, QD Receives: Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Lowering Effect through 24 ABPM
comparing blood pressure lowering effect between night and early morning
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2014
- Primary completionDec 2016 (estimated)
- Study completionApr 2017 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Min Park, Chuncheon Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958631
- Sponsor's protocol ID
- CEFILONE Study
- Status last verified
- Nov 2016
- First submitted
- 5 Nov 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Blood Pressure Lowering Effect Between Fimasartan and Losartan in the Hypertensive Patient During Night and Early Morning Time
- ClinicalTrials.gov ID
- NCT02958631
- Acronym / sponsor ID
- CEFILONE Study
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 8 Nov 2016 (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.
Comparison of blood pressure lowering effect between Fimasartan and Losartan in the hypertensive patient during night and early morning time
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fimasartan | Experimental | Drug: FimasartanFimasartan 60mg, QD |
| Losartan | Active comparator | Drug: LosartanLosartan 50mg, QD |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject don't have Anti-hypertensive drug or who stop Anti-hypertensive drug during 2 weeks
- Office BP: over siSBP 140mmHg or si DBP 90mmHg
- 24hr ABPM: SBP 130mmHg or DBP 80mmHg (24 hour Average)
Key exclusion criteria (3 listed)
- Pregnant, trying to become pregnant or breast feeding
- Subject has Secondary Hypertension
- White coat Blood Pressure (Normal result of 24 hour ABPM)
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: Kanarb | Drug | Fimasartan |
| LosartanAlso: Cozaar | Drug | Losartan |
Primary outcome
Blood Pressure Lowering Effect through 24 ABPM
Time frame: 24 hour
comparing blood pressure lowering effect between night and early morning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Individual participant dataSharing planned: No
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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 4 study testing Fimasartan and Losartan in people with Hypertension, run by Chuncheon Sacred Heart Hospital.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Nov 2016. 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 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?
Results are not available in the source record.
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?
Blood Pressure Lowering Effect through 24 ABPM (time frame: 24 hour). 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 8 Nov 2016.