CClinicalTrials.gg
CompletedNCT03338426FIESTAUpdated Nov 5, 2019

A Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Atorvastatin in Patients With Essential Hypertension and Dyslipidemia

A Phase 3 interventional study of Fimasartan 120mg and Atorvastatin 40mg in Essential Hypertension, Dyslipidemia, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-11-05.

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

Phase
Phase 3
Study type
Interventional
Enrollment
133
Allocation
Randomized
Ages
19 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/atorvastatin treatment group to the fimasartan/placebo treatment group and the placebo/atorvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia.

02

Conditions studied

  • Essential Hypertension, Dyslipidemia
03

Who can participate

Ages eligible
19 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 SiSBP \< 180 mmHg) at the pre- baseline visit (V2) after wash-out period
  5. 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 pre-baseline visit (V2), or orthostatic hypotension accompanied by symptoms
  2. Difference of Sitting systolic blood pressure(SiSBP) ≥ 20 mmHg and Sitting diastolic blood pressure(SiDBP) ≥ 10 mmHg between Lt and Rt arms for 3 consecutive times 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 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 diseasenewly diagnosed within 6 months prior to the screening visit (V1), percutaneous transluminal coronary angioplasty, or coronary artery bypass graft, etc.
  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
04

Study design

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

Study arms

  • Experimental
    Experimental

    Co-administration of a fixed dose combination of Fimasartan 120mg and Atorvastatin 40mg

    Drug: Fimasartan 120mg · Drug: Atorvastatin 40mg

  • Active comparator
    Active Comparator 1

    Co-administration of Fimasartan 120mg and Placebo for Atorvastatin 40mg

    Drug: Fimasartan 120mg · Drug: Placebo for Atorvastatin 40mg

  • Active comparator
    Active Comparator 2

    Co-administration of Atorvastatin 40mg and Placebo for Fimasartan 120mg

    Drug: Atorvastatin 40mg · Drug: Placebo for Fimasartan 120mg

Interventions

  • DrugFimasartan 120mg

    Fimasartan 120mg will be administrated once daily for 8 weeks treatment period

  • DrugAtorvastatin 40mg

    Atorvastatin 40mg will be administrated once daily for 8 weeks treatment period

  • DrugPlacebo for Fimasartan 120mg

    Placebo for Fimasartan 120mg will be administrated once daily for 8 weeks treatment period

  • DrugPlacebo for Atorvastatin 40mg

    Placebo for Atorvastatin 40mg will be administrated once daily for 8 weeks treatment period

05

What researchers measure

Primary outcomes

  1. SiSBP

    The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 2(Atorvastatin 40mg)

    Time frame: 8weeks from Baseline Visit

  2. LDL-C

    The change in LDL-C from baseline in the test group at Week 8 compared to the active comparator group 1(fimasartan 120 mg)

    Time frame: 8weeks from Baseline Visit

Secondary outcomes

  1. SiSBP

    The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 1(Fimasartan 120mg)

    Time frame: 8weeks from Baseline Visit

  2. LDL-C

    The change in LDL-C from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 2(Atorvastatin 40mg)

    Time frame: 8weeks from Baseline Visit

06

Study locations

1 site
  • Severance Hospital
    Seoul, Korea, Republic of
07

Registry details

Key details

Study ID
NCT03338426
Lead sponsor
Boryung Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Nov 9, 2017
Start date
Jan 15, 2018
Primary completion
Apr 22, 2019
Completion
Apr 22, 2019
Last update
Nov 5, 2019

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion