Essential Hypertension, Primary Hypercholesterolemia
Conditions
Brief 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
Interventions
DRUGFimasartan
Subjects take the investigational products once a day for 8 weeks.
Subjects take the investigational products once a day for 8 weeks.
DRUGFimasartan Placebo
Subjects take the investigational products once a day for 8 weeks.
DRUGEzetimibe/Atorvastatin Placebo
Subjects take the investigational products once a day for 8 weeks.
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\<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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean sitting systolic blood pressure | 8weeks from Baseline Visit | The change of mean sitting systolic blood pressure from baseline in BR1017A+BR1017B at Week 8 compared to BR1017B |
| LDL-C | 8weeks from Baseline Visit | The percent of change in LDL-C from baseline in BR1017A+BR1017B at Week 8 compared to BR1017A |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDL-C | 8weeks from Baseline Visit | The percent of change in LDL-C from baseline in BR1017A+BR1017B at Week 8 compared to BR1017B |
| Mean sitting systolic blood pressure | 8weeks from Baseline Visit | The change of mean sitting systolic blood pressure from baseline in BR1017A+BR1017B at Week 8 compared to BR1017A |
Countries
South Korea
Outcome results
None listed