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Essential HypertensionPhase 3NCT05930028

A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia

A Phase 3 study testing Fimasartan and Ezetimibe/Atorvastatin in people with Essential Hypertension and Primary Hypercholesterolemia, 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 clinical study is to evaluate the efficacy and safety by comparing BR1017A+BR1017B treatment group to BR1017A treatment group and BR1017B treatment group respectively at Week 8 in essential hypertension patients with primary hypercholesterolemia Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Fimasartan and Ezetimibe/Atorvastatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
148 participants
Where
1 siteSouth Korea
Study dates
13 Jul 2023to 5 Sep 2024
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

<Inclusion Criteria>

Screening

  • Patients with essential hypertension and primary hypercholesterolemia
  • If patients are being treated with antihypertensive/antihyperlipidemic drugs at screening (V1), they should be determined to be medically reasonable by investigator about discontinuing existing antihypertensive/ antihyperlipidemic drugs during the clinical trial
  • Patients who have an fasting triglyceride (TG) < 400 mg/dL and LDL-C ≤ 250 mg/dL at Screening (V1)
  • Voluntarily provided a written consent to participate in this clinical study
  • Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion

Randomization

  • Patients who meet the following criteria of blood pressure measured in selected reference arm before randomization at baseline(V3)
  • 140 mmHg ≤ MSSBP < 180 mmHg
  • MSDBP < 110 mmHg
  • Patients who meet the criteria of fasting serum lipid levels and risk factors at pre-baseline (V2) after undergoing the therapeutic lifestyle change (TLC)
  • Patients who have an fasting triglyceride (TG) < 400 mg/dL and LDL-C ≤ 250 mg/dL after undergoing the therapeutic lifestyle change (TLC) for at least 4 weeks before pre-baseline (V2)

<Exclusion Criteria>

  • Patients with blood pressure results showing MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg in the selected reference arm at screening(V1) or Baseline(V3)
  • Patients with a difference of MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg in blood pressure measured three times on both arms at screening(V1)
  • Patients with past history and comorbidities at screening(V1) under the following criteria:
  • Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.)
  • Patients with secondary hyperlipidemia: Secondary hyperlipidemia is not limited to the following diseases; (e.g., Chronic renal failure, nephrotic syndrome, obstructive liver disease, hypothyroidism, dysproteinemia, etc.)
  • Patients with orthostatic hypotension accompanied by symptoms

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance Hospital

    Seoul, 120-752

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind, Multi-center, Phase III Trial to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia

The objective of this clinical study is to evaluate the efficacy and safety by comparing BR1017A+BR1017B treatment group to BR1017A treatment group and BR1017B treatment group respectively at Week 8 in essential hypertension patients with primary hypercholesterolemia

Being tested
Fimasartan, Ezetimibe/Atorvastatin, Fimasartan Placebo, Ezetimibe/Atorvastatin Placebo
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

    Also called BR1017A

    Subjects take the investigational products once a day for 8 weeks.

  • Ezetimibe/AtorvastatinDrug

    Also called BR1017B

    Subjects take the investigational products once a day for 8 weeks.

  • Fimasartan PlaceboDrug

    Also called BR1017A-1

    Subjects take the investigational products once a day for 8 weeks.

  • Ezetimibe/Atorvastatin PlaceboDrug

    Also called BR1017B-1

    Subjects take the investigational products once a day for 8 weeks.

Study groups in NCT05930028
Study groupRoleWhat they receive
Fimasartan/Ezetimibe/AtorvastatinExperimentalBR1017A+BR1017B(Experimental Group)
Receives: Drug: Fimasartan; Drug: Ezetimibe/Atorvastatin
FimasartanActive comparatorBR1017A(Control Group 2)
Receives: Drug: Fimasartan; Drug: Ezetimibe/Atorvastatin Placebo
Ezetimibe/AtorvastatinActive comparatorBR1017B(Control Group 1)
Receives: Drug: Ezetimibe/Atorvastatin; Drug: Fimasartan Placebo

What is being measured

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

  1. Mean sitting systolic blood pressure

    The change of mean sitting systolic blood pressure from baseline in BR1017A+BR1017B at Week 8 compared to BR1017B

    Measured: 8weeks from Baseline Visit

  2. LDL-C

    The percent of change in LDL-C from baseline in BR1017A+BR1017B at Week 8 compared to BR1017A

    Measured: 8weeks from Baseline Visit

Secondary outcomes (2)

  1. LDL-C

    The percent of change in LDL-C from baseline in BR1017A+BR1017B at Week 8 compared to BR1017B

    Measured: 8weeks from Baseline Visit

  2. Mean sitting systolic blood pressure

    The change of mean sitting systolic blood pressure from baseline in BR1017A+BR1017B at Week 8 compared to BR1017A

    Measured: 8weeks from Baseline Visit

Timeline

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

  1. First posted5 Jul 2023
  2. Study start13 Jul 2023
  3. Primary completion5 Sep 2024
  4. Study completion5 Sep 2024

Resources

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05930028
Sponsor's protocol ID
BR-FAEC-CT-301
Status last verified
Oct 2024
First submitted
26 Jun 2023
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fimasartan and Ezetimibe/Atorvastatin in people with Essential Hypertension and Primary Hypercholesterolemia, 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?

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 18 Oct 2024. 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?

Mean sitting systolic blood pressure (time frame: 8weeks from Baseline Visit). The study lists 2 primary outcomes in all. 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 NCT05930028.

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 18 Oct 2024.

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