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NCT05930028CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 18 Oct 2024

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
148 (actual)
First submitted
26 Jun 2023
Start date
13 Jul 2023
Primary completion date
5 Sept 2024
Lead sponsor
Boryung Pharmaceutical Co., Ltd
NCT number
NCT05930028

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 148
  • From 13 Jul 2023 to the primary completion date, 5 Sept 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • \<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

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Severance hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.