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AzTrials

Essential Hypertension, DyslipidemiaPhase 3NCT02166814

A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination of Fimasartan/Rosuvastatin in Comparison to Each Component Administered Alone in Patients With Essential Hypertension and Dyslipidemia

A Phase 3 study testing Fimasartan and Rosuvastatin, Fimasartan and Rosuvastatin in people with Essential Hypertension, Dyslipidemia, run by Boryung Pharmaceutical Co., Ltd at 26 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of combination of Fimasartan/Rosuvastatin in comparison to each component administered alone in patients with essential hypertension and dyslipidemia. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Essential Hypertension, Dyslipidemia
What is being tested?
Fimasartan and Rosuvastatin, Fimasartan and Rosuvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
26 sitesSouth Korea
Study dates
Aug 2014to Sep 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who voluntarily signed informed consent for participating in this clinical trial
  • Male and female between 20 and 75 years old
  • Patients must have been confirmed essential hypertension and dyslipidemia at Screening visit (Visit1)
  • Patients who meet the following criteria of fasting LDL-C and blood pressure at Baseline visit (Visit3) assessment after undergoing the therapeutic lifestyle change.
  • Low risk group: the case that does not have any other risk factor apart from hypertension / LDL-C (mg/dL): ≥160, ≤250, Mean SiSBP(mmHg): ≥140, <180
  • Moderate risk group: the case that has more than or equal to one risk factor apart from hypertension and has the 10-year risk of less than 10% / LDL-C (mg/dL): ≥160, ≤250, Mean SiSBP(mmHg): ≥140, <180
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  • Moderate high risk group: the case that has more than or equal to one risk factor apart from hypertension and has the 10-year risk between 10% and 20% / LDL-C (mg/dL): ≥130, ≤250, Mean SiSBP(mmHg): ≥140, <180
  • High risk group: the case of CHD (Coronary heart disease) or CHD risk equivalents
  • Risk factors include cigarette smoking, hypertension (BP≥140/90 mmHg or on antihypertensive medication), low HDL cholesterol (<40mg/dL), family history of premature CHD(CHD in male first-degree relative <55 years of age; CHD in female first-degree relative < 65 years of age), and age (men≥45 years; women ≥55 years). in case of HDL-C ≥60mg/dL, reduce 1 from the total number of risk factors.
  • Electronic 10 year risk calculators are available at www.nhlbi.nih.gov/guidelines/cholesterol
  • CHD includes history of myocardial infarction, unstable angina, coronary artery procedures (angioplasty or bypass surgery), or evidence of clinically significant myocardial ischemia.
  • CHD risk equivalents include atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm and carotid artery disease [transient ischemic attacks or stroke of carotid origin or >50% obstruction of a carotid artery]), diabetes and 2+ risk factors with 10 year risk of over 20%
  • Subject must be able to understand the trial procedures and be willing to cooperate and complete the trial.

Who cannot join

  • Severe hypertension patients with mean siSBP ≥ 180mmHg and/or SiDBP ≥110mmHg at the assessment of Screening visit (Visit1) and/or Baseline visit (Visit3). Or patients with postural hypotension with manifestation.
  • Patients with the mean SiSBP from 3 times of measurement of over 20mmHg.
  • Secondary hypertension patients, but not limited to the following disease (example: renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, etc)
  • Secondary dyslipidemia: nephrotic syndrome, dysproteinemia, obstructive hepatopathy or Cushing's syndrome.
  • Patients with fasting TG ≥ 400mg/dL at Pre-Baseline visit (Visit2) assessment
  • History of myopathy, rhabdomyolysis or/and CK ≥ 2 times upper normal limit.
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  • Use of lipid modifying drug within 4 weeks prior to Pre-Baseline visit (Visit2) and/or antihypertensive drug within 2 weeks prior to Pre-Baseline visit(Visit2)
  • Clinically significant renal function abnormality in the laboratory results at Pre-Baseline visit (i.e. serum creatinine ≥ 1.5 times upper normal limit), liver function abnormality (ALT, AST ≥ 2 times upper normal limit), severe fatty liver disease that requires medication.
  • Clinically significant hypokalemia(less than 3.5 mmol/L) or hyperkalemia (exceeded 5.5 mmol/L) measured at Pre-Baseline visit (Visit2)
  • Subjects with following surgical and internal disease that may affect absorption, distribution, metabolism or excretion of drugs and have conditions which include the following (but are not limited to): history of major gastrointestinal surgeries including gastrectomy, gastro-enterostomy or bowel resection, gastrointestinal bypass graft and stabling; current active gastritis, ulcer, gastrointestinal and rectal bleeding, presence of active inflammatory bowel syndrome or biliary obstruction with the past 12 months.
  • Subjects with depletion of body fluid or sodium ion not able to correct
  • Subjects with sever insulin-dependent Diabetes Mellitus(DM) or Chronic DM (HbA1c > 9% at Pre-Baseline visit, dosage of an oral hypoglycemic agent was modified within 12 weeks prior to screening visit , or currently use of active insulin treatment) or with hypothyroidism not able to correct.( TSH ≥ 1.5 times upper normal limit)
  • Subjects with severe heart disease (Heart failure New York Heart Association(NYHA) class 3 and 4), or history of any of the followings within the past 6 months; ischemic heart disease (e.g. angina pectoris, myocardial infarction), peripheral vascular disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft.
  • Subjects with clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or any other clinical significant arrhythmia conditions at discretion of investigator
  • Subjects with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve stenosis, or mitral valve stenosis.
  • Subjects with severe cerebrovascular disorder (e.g. stroke, cerebral infarction or cerebral hemorrhage within the past 6 months)
  • Subjects with chronic inflammatory disease requiring an chronic anti-inflammatory therapy, past or current medical history with wasting disease, autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus) or connective tissue disease.
  • Subjects with known moderate or malignant retinosis (e.g. retinal hemorrhage, visual disturbance or retinal microaneurysm in the past 6 months)
  • Subjects with hepatitis B (including positive test for HBsAg), hepatitis C-positive
  • Subjects with history or evidence of abusing drugs or alcohol within the past 2 years.
  • Medical history with hypersensitivity to angiotensin II antagonist based drugs or HMG-CoA reductase inhibitor based drugs or any ingredient contained in these 2 drugs.
  • Medical history with clinically significant hypersensitivity to any components or other drugs on the investigational product or additives (yellow 5)
  • Subjects with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
  • Pregnant women and lactating female.
  • Subjects planning pregnancy or childbearing potential who are not using effective contraceptive methods (surgical sterilized, intrauterine (contraceptive) device/condom or the combination of diaphragm and spermicidal agents)
  • Subjects who are participating in another trial or took other investigational product within 12 weeks prior to Screening visit
  • Medical history of all kinds of malignant tumor including leukemia and lymphoma in the past 5 years
  • A subject with other reasons not specified above that, ineligible to participate in this clinical trial at discretion of study investigators.

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

South Korea26 sites

  • Seoul university Bundang hospital

    Bundang

  • Dong-A university hospital

    Busan

  • Inje Heaundai Paik hospital

    Busan

  • Inje university Busan Paik hospital

    Busan

  • The Catholic university of Korea Daegu hospital

    Daegu

  • DongGuk university Gyeongju hospital

    Gyeongju

  • DongGuk university Ilsan hospital

    Ilsan

  • Inje university Ilsan Paik hospital

    Ilsan

  • Gachon university Gil medical center

    Incheon

  • Inha university hospital

    Incheon

  • Jeju national university hospital

    Jeju City

  • JeonNam university hospital

    JeonNam

  • ChungNam university hospital

    Jungnam

  • DanGuk university hospital

    Jungnam

  • Kyungbook National university hospital

    Kyungbook

  • Gangnam Severance hospital

    Seoul

  • Jeil hospital

    Seoul

  • Korea university Anam hospital

    Seoul

  • Korea university Guro hospital

    Seoul

  • Kyunghee university hospital

    Seoul

  • Samsung Seoul hospital

    Seoul

  • Seoul national university hospital

    Seoul

  • Severance hospital

    Seoul

  • The Catholic university St. Mary hospital

    Seoul

  • Aju university hospital

    Suwon

  • YoungNam university hospital

    YoungNam

Other trials in South Korea

About this study

The purpose of this study is to evaluate the efficacy and safety of combination of Fimasartan/Rosuvastatin in comparison to each component administered alone in patients with essential hypertension and dyslipidemia.

Being tested
Fimasartan and Rosuvastatin, Fimasartan, Rosuvastatin
Medical subject headings
Essential Hypertension, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fimasartan and RosuvastatinDrug

  • FimasartanDrug

  • RosuvastatinDrug

Study groups in NCT02166814
Study groupRoleWhat they receive
Fimasartan and RosuvastatinExperimentalCombination of Fimasartan and Rosuvastatin
Receives: Drug: Fimasartan and Rosuvastatin
FimasartanActive comparatorFimasartan monotherapy
Receives: Drug: Fimasartan
RosuvastatinActive comparatorRosuvastatin monotherapy
Receives: Drug: Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change rate of LDL-C at week 8 of Fimasartan/Rosuvastatin combination administration from the Baseline to compare the one of Fimasartan 120mg single administration

    Measured: 8 weeks from Baseline Visit

  2. Change of SiSBP at week 8 of Fimasartan/Rosuvastatin combination administration from the Baseline to compare the one of Rosuvastatin 20mg single administration

    Measured: 8 weeks from Baseline Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02166814
Sponsor's protocol ID
BR-FRC-CT-301
Status last verified
Jun 2014
First submitted
16 Jun 2014
Last updated
13 Feb 2017
Results posted
No

Publications

  • Rhee MY, Ahn T, Chang K, Chae SC, Yang TH, Shim WJ, Kang TS, Ryu JK, Nah DY, Park TH, Chae IH, Park SW, Lee HY, Tahk SJ, Yoon YW, Shim CY, Shin DG, Seo HS, Lee SY, Kim DI, Kwan J, Joo SJ, Jeong MH, Jeong JO, Sung KC, Kim SY, Kim SH, Chun KJ, Oh DJ. The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia. BMC Pharmacol Toxicol. 2017 Jan 5;18(1):2. doi: 10.1186/s40360-016-0112-7.

    PubMed 28057081

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fimasartan and Rosuvastatin, Fimasartan and Rosuvastatin in people with Essential Hypertension, Dyslipidemia, run by Boryung Pharmaceutical Co., Ltd at 26 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change rate of LDL-C at week 8 of Fimasartan/Rosuvastatin combination administration from the Baseline to compare the one of Fimasartan 120mg single administration (time frame: 8 weeks from Baseline Visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02166814, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017.

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