The Elderly (≥ 70 Years) With Essential HypertensionPhase 3FITNESSNCT03246555

Fimasartan in the Senior Subjects

A Phase 3 study testing Fimasartan or Fimasartan/Hydrochlorothiazide and Perindopril or Perindopril/Indapamide in people with The Elderly (≥ 70 Years) With Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to confirm the noninferiority of the blood pressure lowering effect of fimasartan and evaluate its safety compared to perindopril in the elderly with essential hypertension. Read more about this study

Who is it for?: Ages 70 years and older
Conditions the study is for: The Elderly (≥ 70 Years) With Essential Hypertension
What is being tested?: Fimasartan or Fimasartan/Hydrochlorothiazide and Perindopril or Perindopril/Indapamide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 241 participants
Where: 1 siteSouth Korea
Study dates: 15 Jul 2016to 9 Dec 2019
Phase: Phase 3
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 70 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Voluntarily provided a written consent to participate in this clinical study after receiving an explanation of this study
Elderly aged 70 years or older
At the screening visit (Visit 1), Blood pressure: Mean blood pressure measured 3 times on the selected arm is as below.
For treatment-naïve patients who have not taken drugs for hypertension within the last 3 months from the screening visit: Mean siSBP ≥ 140mmHg
For patients with essential hypertension who are taking drugs for hypertension: Mean siSBP ≥ 130mmHg
At the baseline visit (Visit 2), Blood pressure: Patients with mild to moderate essential hypertension whose mean siSBP measured 3 times on the selected arm is ≥140 mmHg Patients with treatment compliance of ≥70% during the placebo run-in period
Capable of understanding written instructions, cooperative, able to participate until the end of the clinical study

Who cannot join

Severe hypertension patients with mean siSBP ≥ 180 mmHg or siDBP ≥ 110 mmHg (office BP) at the screening visit (Visit 1) and the baseline visit (Visit 2) (However, at screening, it is based on the blood pressures measured from both arms, and the patient is excluded if the result from any of the arms falls within the criteria.)
Patients with siSBP ≥ 20 mmHg and siDBP ≥ 10 mmHg in the difference between blood pressures in the selected arm at the screening visit (Visit 1)
Patients with a history of secondary hypertension and any history suspected of secondary hypertension (but not limited to the following: coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, etc.)
Orthostatic hypotension with symptoms
Patients with insulin-dependent diabetes mellitus or uncontrolled diabetes mellitus (HbA1c > 9.0% at the screening visit (Visit 1))
Patients with a history of malignant tumor, including leukemia and lymphoma, within the past 5 years (however, participation is allowed if it has not recurred for at least 5 years after a tumor surgery)

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Patients with any chronic inflammatory disease requiring chronic anti-inflammatory treatment, consumption disease, autoimmune disease like rheumatoid arthritis and systemic lupus erythematosus, etc., or connective tissue disease at present or in the past
Patients with a history of hypersensitivity reaction to any component of the investigational product and its similar compound Renin-angiotensin system inhibitors, ACE inhibitors, thiazide diuretics and sulfonamides, Yellow 5 (Sunset Yellow FCF), etc.
Patients with hyperlipidemia undergoing LDL (low density lipoprotein) apheresis (patients undergoing LDL hemapheresis using a dextran sulfate cellulose)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Bundang
Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind, Active-controlled, 2-parallel Group, Optional Titration, Multicenter, Phase 3b Study to Evaluate the Efficacy and Safety of Fimasartan Versus Perindopril Monotherapy With and Without Diuretics Combination in Elderly Patients With Essential Hypertension

Conditions: The Elderly (≥ 70 Years) With Essential Hypertension
Being tested: Fimasartan or Fimasartan/Hydrochlorothiazide, Perindopril or Perindopril/Indapamide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fimasartan or Fimasartan/HydrochlorothiazideDrug
The treatment in this clinical study starts with fimasartan 30 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product.
Perindopril or Perindopril/IndapamideDrug
The treatment in this clinical study starts with penrindopril 2.5 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product.

Study groups in NCT03246555
Study group	Role	What they receive
Fimasartan or Fimasartan/Hydrochlorothiazide	Experimental	Not described Receives: Drug: Fimasartan or Fimasartan/Hydrochlorothiazide
Perindopril or Perindopril/Indapamide	Active comparator	Not described Receives: Drug: Perindopril or Perindopril/Indapamide

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in siSBP
Change in siSBP from baseline after the administration of the investigational product for 8 weeks
Measured: 8 weeks

Secondary outcomes (4)

Change in siSBP
Change in siSBP from baseline at Weeks 4, 16 and 24
Measured: Weeks 4, 16 and 24
Change in siDBP
Change in siDBP from baseline at Weeks 4, 8, 16 and 24
Measured: Weeks 4, 8, 16 and 24
Blood pressure response rate
Blood pressure response rate (siSBP < 140 mmHg, or decrease of △siSBP ≥ 20 mmHg after the administration for 4, 8 and 16 weeks compared to baseline) and blood pressure normalization rate after the administration of the investigational products for 4, 8 and 16 weeks(siSBP<140mmHg and siDBP<90mmHg)
Measured: 4, 8 and 16 weeks
Change from baseline in the differences in standing SBP and DBP compared to their sitting measurements
Change from baseline in the differences in standing SBP and DBP compared to their sitting measurements after the administration of the investigational product for 4, 8, 16 and 24 weeks
Measured: 4, 8, 16 and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 20169 Dec 2019

First posted11 Aug 2017
Study start15 Jul 2016
Primary completion19 Aug 2019
Study completion9 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for The Elderly (≥ 70 Years) With 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel Assignment
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 241 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03246555
Sponsor's protocol ID: BR-FMS-CT-304
Acronym: FITNESS
Status last verified: Mar 2020
First submitted: 25 Jul 2017
Last updated: 23 Mar 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Lee HY, Kim KI, Ihm SH, Rhee MY, Sohn IS, Park S, Jeon ES, Song JM, Pyun WB, Sung KC, Kim MH, Kim SH, Kim SY, Kim SJ, Kim EJ, Shin J, Lee SY, Chun KJ, Jeong JO, Chae SC, Yoo KD, Choi YJ, Park YH, Kim CH. A Randomized, Double-blind, Active-controlled, Two Parallel-Group, Optional Titration, Multicenter, Phase IIIb Study to Evaluate the Efficacy and Safety of Fimasartan Versus Perindopril Monotherapy With and Without a Diuretic Combination in Elderly Patients With Essential Hypertension. Clin Ther. 2021 Oct;43(10):1746-1756. doi: 10.1016/j.clinthera.2021.08.003. Epub 2021 Sep 7.
PubMed 34503866
Kang MG, Kim KI, Ihm SH, Rhee MY, Sohn IS, Lee HY, Park S, Jeon ES, Song JM, Pyun WB, Sung KC, Kim MH, Kim SH, Kim SY, Kim SJ, Kim EJ, Shin J, Lee SY, Chun KJ, Jeong JO, Chae SC, Yoo KD, Choi YJ, Park YH, Kim CH. Fimasartan versus perindopril with and without diuretics in the treatment of elderly patients with essential hypertension (Fimasartan in the Senior Subjects (FITNESS)): study protocol for a randomized controlled trial. Trials. 2019 Jul 1;20(1):389. doi: 10.1186/s13063-019-3466-5.
PubMed 31262348

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Active-controlled, 2-parallel Group, Optional Titration, Multicenter, Phase 3b Study to Evaluate the Efficacy and Safety of Fimasartan Versus Perindopril Monotherapy With and Without Diuretics Combination in Elderly Patients With Essential Hypertension
ClinicalTrials.gov ID: NCT03246555
Acronym / sponsor ID: FITNESS / BR-FMS-CT-304
Conditions: The Elderly (≥ 70 Years) With Essential Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 241 participants (actual)
Lead sponsor: Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: 15 Jul 2016 (actual)
Primary completion: 19 Aug 2019 (actual)
Study completion: 9 Dec 2019 (actual)
First posted: 11 Aug 2017 (actual)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: Parallel Assignment

Arm	Type	Receives
Fimasartan or Fimasartan/Hydrochlorothiazide	Experimental	Drug: Fimasartan or Fimasartan/Hydrochlorothiazide
Perindopril or Perindopril/Indapamide	Active comparator	Drug: Perindopril or Perindopril/Indapamide

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (7 listed)

Voluntarily provided a written consent to participate in this clinical study after receiving an explanation of this study
Elderly aged 70 years or older
At the screening visit (Visit 1), Blood pressure: Mean blood pressure measured 3 times on the selected arm is as below.
At the baseline visit (Visit 2), Blood pressure: Patients with mild to moderate essential hypertension whose mean siSBP measured 3 times on the selected arm is ≥140 mmHg Patients with treatment compliance of ≥70% during the placebo run-in period
Capable of understanding written instructions, cooperative, able to participate until the end of the clinical study

Key exclusion criteria (9 listed)

Severe hypertension patients with mean siSBP ≥ 180 mmHg or siDBP ≥ 110 mmHg (office BP) at the screening visit (Visit 1) and the baseline visit (Visit 2) (However, at screening, it is based on the blood pressures measured from both arms, and the patient is excluded if the result from any of the arms falls within the criteria.)
Patients with siSBP ≥ 20 mmHg and siDBP ≥ 10 mmHg in the difference between blood pressures in the selected arm at the screening visit (Visit 1)
Patients with a history of secondary hypertension and any history suspected of secondary hypertension (but not limited to the following: coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, etc.)
Orthostatic hypotension with symptoms
Patients with insulin-dependent diabetes mellitus or uncontrolled diabetes mellitus (HbA1c > 9.0% at the screening visit (Visit 1))

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 or Fimasartan/HydrochlorothiazideThe treatment in this clinical study starts with fimasartan 30 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product.	Drug	Fimasartan or Fimasartan/Hydrochlorothiazide
Perindopril or Perindopril/IndapamideThe treatment in this clinical study starts with penrindopril 2.5 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product.	Drug	Perindopril or Perindopril/Indapamide

Primary outcome

Change in siSBP
Time frame: 8 weeks
Change in siSBP from baseline after the administration of the investigational product for 8 weeks

4 secondary outcomes

Change in siSBP
Time frame: Weeks 4, 16 and 24
Change in siDBP
Time frame: Weeks 4, 8, 16 and 24
Blood pressure response rate
Time frame: 4, 8 and 16 weeks
Change from baseline in the differences in standing SBP and DBP compared to their sitting measurements
Time frame: 4, 8, 16 and 24 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 23 Mar 2020.
Derived from this study: PubMed 34503866Lee HY, Kim KI, Ihm SH, Rhee MY, Sohn IS, Park S, Jeon ES, Song JM, Pyun WB, Sung KC, Kim MH, Kim SH, Kim SY, Kim SJ, Kim EJ, Shin J, Lee SY, Chun KJ, Jeong JO, Chae SC, Yoo KD, Choi YJ, Park YH, Kim CH. A Randomized, Double-blind, Active-controlled, Two Parallel-Group, Optional Titration, Multicenter, Phase IIIb Study to Evaluate the Efficacy and Safety of Fimasartan Versus Perindopril Monotherapy With and Without a Diuretic Combination in Elderly Patients With Essential Hypertension. Clin Ther. 2021 Oct;43(10):1746-1756. doi: 10.1016/j.clinthera.2021.08.003. Epub 2021 Sep 7.
Derived from this study: PubMed 31262348Kang MG, Kim KI, Ihm SH, Rhee MY, Sohn IS, Lee HY, Park S, Jeon ES, Song JM, Pyun WB, Sung KC, Kim MH, Kim SH, Kim SY, Kim SJ, Kim EJ, Shin J, Lee SY, Chun KJ, Jeong JO, Chae SC, Yoo KD, Choi YJ, Park YH, Kim CH. Fimasartan versus perindopril with and without diuretics in the treatment of elderly patients with essential hypertension (Fimasartan in the Senior Subjects (FITNESS)): study protocol for a randomized controlled trial. Trials. 2019 Jul 1;20(1):389. doi: 10.1186/s13063-019-3466-5.

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?

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 7 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 23 Mar 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 in siSBP (time frame: 8 weeks). 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 NCT03246555, which also lists 2 linked publications.

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 Mar 2020.