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CompletedNCT03156842FIRSTUpdated Jun 10, 2019

Combination of Fimasartan/Amlodipine/Rosuvastatin in Patients With Essential Hypertension and Dyslipidemia

A Phase 3 interventional study of Fimasartan/Amlodipine, Rosuvastatin and Fimasartan/Amlodipine in Essential Hypertension and Dyslipidemia, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-06-10.

Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

The objective of this clinical study is to evaluate the efficacy and safety by comparing the fimasartan/amlodipine/rosuvastatin treatment group to the fimasartan/amlodipine treatment group and the fimasartan/rosuvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia who fail to respond to the fimasartan monotherapy.

02

Conditions studied

  • Essential Hypertension
  • Dyslipidemia

Keywords

  • Hypertension
  • Dyslipidemia
  • Fimasartan
  • Rosuvastatin
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 138 is above the median of 90 across 4,994 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Boryung Pharmaceutical Co., Ltd is the lead sponsor of 139 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Voluntarily provided a written consent to participate in this clinical study
  2. Male or female adults aged 19-70 years
  3. Patients must have been confirmed essential hypertension and dyslipidemia at Screening visit (V1)
  4. Uncontrolled blood pressure (140 mmHg ≤ mean Sitting systolic blood pressure(SiSBP) \< 180 mmHg) at the baseline visit (V3) after the fimasartan 60 mg monotherapy
  5. Subjects who meet the following criteria of fasting serum lipid levels confirmed at the baseline visit (V3) after undergoing the therapeutic lifestyle change (TLC)
  6. Treatment compliance of fimasartan 60 mg ≥70% at the baseline visit (V3)
  7. Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion

Exclusion criteria

Exclusion Criteria:

  1. Severe hypertension with mean Sitting systolic blood pressure(SiSBP) ≥180 mmHg or Sitting diastolic blood pressure(SiDBP) ≥110 mmHg at the screening visit (V1) and the baseline visit (V2, or orthostatic hypotension accompanied by symptoms
  2. Differences between arms greater than 20 mmHg for Sitting systolic blood pressure(SiSBP) and 10 mmHg for Sitting diastolic blood pressure(SiDBP) are present on 3 consecutive readings at the screening visit (V1)
  3. Secondary hypertension patients: Secondary hypertension is not limited to the following diseases; (e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma, and polycystic kidney disease)
  4. Uncontrolled diabetes mellitus (currently on insulin, or HbA1c >9% at the pre-baseline visit (V2)), or uncontrolled hypothyroidism (TSH ≥1.5 times the upper limit of normal at the pre-baseline visit (V2))
  5. Heart disease (heart failure of New York Heart Association (NYHA) class 3 and 4), or ischemic heart disease (angina pectoris, myocardial infarction), peripheral vascular disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft, etc. within 6 months prior to the screening visit (V1)
  6. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator
  7. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant aortic valve stenosis or mitral valve stenosis
  8. Cerebrovascular disorder (stroke, cerebral infarction, transient cerebral ischemic attack, cerebral hemorrhage, etc. within 6 months prior to the screening visit (V1)
  9. Pregnant or lactating women
  10. Planning pregnancy during the study period or have childbearing potential but are not using acceptable contraceptive methods (Contraceptive methods: Refer to Section 10.1 in this document.)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
138 participants (actual)

Study arms

  • Experimental
    Fimasartan/Amlodipine, Rosuvastatin

    Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin

    Drug: Fimasartan/Amlodipine, Rosuvastatin

  • Active comparator
    Fimasartan/Amlodipine

    a fixed dose combination of Fimasartan/Amlodipine

    Drug: Fimasartan/Amlodipine

  • Active comparator
    Fimasartan, Rosuvastatin

    Co-administration of Fimasartan and Rosuvastatin

    Drug: Fimasartan, Rosuvastatin

Interventions

  • DrugFimasartan/Amlodipine, Rosuvastatin

    "A fixed dose combination tablet of Fimasartan and Amlodipine" and "Rosuvastatin" will be administrated once daily on treatment period.

  • DrugFimasartan/Amlodipine

    "A fixed dose combination tablet of Fimasartan and Amlodipine" will be administrated once daily on treatment period.

  • DrugFimasartan, Rosuvastatin

    "Fimasartan" and "Rosuvastatin" will be administrated once daily on treatment period.

06

What researchers measure

Primary outcomes

  1. LDL-C

    The percent change in LDL-C from baseline in the test group at Week 8 compared to the fimasartan 60 mg/amlodipine 10 mg combination treatment group

    Time frame: 8weeks from Baseline Visit

  2. Sitting systolic blood pressure(SiSBP)

    The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group at Week 8 compared to the fimasartan 60 mg and rosuvastatin 20 mg concomitant treatment group

    Time frame: 8weeks from Baseline Visit

Secondary outcomes

  1. Sitting systolic blood pressure(SiSBP)

    The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group at Week 8 compared to the fimasartan 60 mg/amlodipine 10 mg combination treatment group

    Time frame: 8weeks from Baseline Visit

  2. LDL-C

    The percent change in LDL-C from baseline in the test group at Week 8 compared to the fimasartan 60 mg and rosuvastatin 20 mg concomitant treatment group

    Time frame: 8weeks from Baseline Visit

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03156842
Lead sponsor
Boryung Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
May 17, 2017
Start date
May 29, 2017
Primary completion
Dec 7, 2018
Completion
Dec 7, 2018
Last update
Jun 10, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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