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NCT Number: NCT05930028

A Study 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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

<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

Treatment and study plan

Fimasartan

Drug

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

Other names: BR1017A

Ezetimibe/atorvastatin

Drug

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

Other names: BR1017B

Fimasartan Placebo

Drug

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

Other names: BR1017A-1

Ezetimibe/Atorvastatin Placebo

Drug

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

Other names: BR1017B-1

Primary outcomes

  1. Mean sitting systolic blood pressure

    Time frame: 8weeks from Baseline Visit

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

  2. LDL-C

    Time frame: 8weeks from Baseline Visit

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

Secondary outcomes

  1. LDL-C

    Time frame: 8weeks from Baseline Visit

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

  2. Mean sitting systolic blood pressure

    Time frame: 8weeks from Baseline Visit

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

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 5, 2023
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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