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

NCT ID: NCT05930028

Last Updated: 2024-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-13

Study Completion Date

2024-09-05

Brief Summary

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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

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Detailed Description

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Conditions

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Essential Hypertension Primary Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fimasartan/Ezetimibe/Atorvastatin

BR1017A+BR1017B(Experimental Group)

Group Type EXPERIMENTAL

Fimasartan

Intervention Type DRUG

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

Ezetimibe/Atorvastatin

Intervention Type DRUG

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

Fimasartan

BR1017A(Control Group 2)

Group Type ACTIVE_COMPARATOR

Fimasartan

Intervention Type DRUG

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

Ezetimibe/Atorvastatin Placebo

Intervention Type DRUG

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

Ezetimibe/Atorvastatin

BR1017B(Control Group 1)

Group Type ACTIVE_COMPARATOR

Ezetimibe/Atorvastatin

Intervention Type DRUG

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

Fimasartan Placebo

Intervention Type DRUG

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

Interventions

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Fimasartan

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

Intervention Type DRUG

Ezetimibe/Atorvastatin

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

Intervention Type DRUG

Fimasartan Placebo

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

Intervention Type DRUG

Ezetimibe/Atorvastatin Placebo

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

Intervention Type DRUG

Other Intervention Names

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BR1017A BR1017B BR1017A-1 BR1017B-1

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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BR-FAEC-CT-301

Identifier Type: -

Identifier Source: org_study_id

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