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FimasaRtan-basEd BP Targets After Drug SwitcHing (FRESH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649646
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd

Brief Summary:
Among major risk factors for stroke and major cardiovascular diseases, hypertension needs to be managed proactively as it can be controlled with the aid of proper drugs. There are still many occasions with unsatisfactory result of hypertension control even though a wide class of antihypertensive drugs are available. This is because factors affecting the effects of selected antihypertensive drugs such as the underlying disease, other concomitant medications, and treatment compliance of each patient are different. Especially, the timing for treatment initiation should vary depending on the risk of cardio-cerebrovascular disease, and studies on target blood pressure (BP) criteria require study results in actual treatment setting with a broad range of patients. The recent hypertension clinical practice guidelines published by American College of Cardiology (ACC) and American Heart Association (AHA) reduced the target BP to 130/80 mmHg, indicating the needs for more aggressive efforts in hypertension treatment. However, studies in Koreans must be preceded before applying such new overseas guidelines; thus, this study has been designed to establish clinical materials reflecting treatment setting in Korea. In this study, patients with uncontrolled hypertension whose antihypertensive regimens are changed to ARB-based therapy (ARB monotherapy or ARB-containing combination therapy) will be followed to assess the treatment trend, treatment effect, and risk of cardiovascular disease.

Condition or disease
Essential Hypertension

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multi-center, Open, Longitudinal, Observational Study to Assess the Treatment Trend and the Proportion of Target Blood Pressure Attainment in Patients Whose Antihypertensive Regimens Are Changed to Angiotensin Receptor Blocker-based Therapy
Actual Study Start Date : July 3, 2018
Estimated Primary Completion Date : September 9, 2020
Estimated Study Completion Date : September 9, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Patients
Patients with hypertension uncontrolled by antihypertensive drug



Primary Outcome Measures :
  1. Blood pressure (BP) (Systolic and Diastolic) [ Time Frame: Week 12 after the treatment regimen change ]
    Proportion of patients who attain the target blood pressure (BP) (<140(SBP)/90(DBP) mmHg) at Week 12 after the treatment regimen change


Secondary Outcome Measures :
  1. Target BP (<140/90 mmHg) (Systolic and Diastolic) [ Time Frame: Week 12 after the treatment regimen change ]

    Proportion of patients who attain the target BP(<140/90 mmHg) specified in 2013 hypertension clinical practice guidelines suggested by Korean Society of Hypertension at Week 12 after the treatment regimen change

    • The elderly patients (≥80 years): <150/90 mmHg
    • Patients with diabetes: <140/85 mmHg
    • Patients with chronic kidney disease accompanying albuminuria: <130/80 mmHg

  2. Target BP(<130/80mmHg) (Systolic and Diastolic) [ Time Frame: Week 12 after the treatment regimen change ]
    Proportion of patients who attain the target BP(<130(SBP)/80(DBP)mmHg) specified in 2017 clinical practice guidelines for hypertension suggested by American College of Cardiology(ACC)/American Heart Association(AHA) at Week 12 after the treatment regimen change Frequency and proportion of patients who attain the target BP specified in 2017 hypertension clinical practice guidelines suggested by ACC/AHA at Week 12 after the treatment regimen change will be calculated and the 95% confidence interval for the proportion will be provided.

  3. Investigator's target BP (Systolic and Diastolic) [ Time Frame: Week 12 after the treatment regimen change ]
    Proportion of patients who attain the investigator's target BP at Week 12 after the treatment regimen change

  4. Target BP pattern (Systolic and Diastolic) [ Time Frame: at the time of study enrollment ]
    Target BP pattern of the investigators dependent on study site, region, type of medical institution, risk of cardio-cerebrovascular disease, and the BP at the time of study enrollment

  5. BP control rate (Systolic and Diastolic) [ Time Frame: Week 12 after the treatment regimen change ]
    Analysis of exploratory factors for BP control rate (based on primary endpoint)

  6. Framingham score (10-year risk of cardiovascular disease) [ Time Frame: Week 12 after the treatment regimen change ]

    Change in the Framingham score at Week 12 after the treatment regimen change

    <Framingham risk score> (10-year risk of cardiovascular disease)

    Framingham scores will be calculated by total points based on the coronary risk factors including age, gender, total cholesterol, HDL-cholesterol, systolic blood pressure, diabetic and smoking habits.

    Women (Total points:Risk(%))

    <=-2:<1 / -1:1.0 / 0:1.2 / 1:1.5 / 2:1.7 / 3:2.0 / 4:2.4 / 5:2.8 / 6:3.3 / 7:3.9 / 8:4.5 / 9:5.3 / 10:6.3 / 11:7.3 / 12:8.6 / 13:10.0 / 14:11.7 / 15:13.7 / 16:15.9 / 17:18.5 / 18:21.5 / 19:24.8 / 20:28.5 / 21+:>30

    Men

    <=-3 or less:<1 / <=-2:1.1 / -1:1.4 / 0:1.6 / 1:1.9 / 2:2.3 / 3:2.8 / 4:3.3 / 5:3.9 / 6:4.7 / 7:5.6 / 8:6.7 / 9:7.9 / 10:9.4 / 11:11.2 / 12:13.2 / 13:15.6 / 14:18.4 / 15:21.6 / 16:25.3 / 17:29.4 / 18:>30

    (Please refer to the paper─D'Agostino RB Sr, Vasan RS et al. (2008) General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 117: 743-753)


  7. Difference in the proportion of target BP attainment (Systolic and Diastolic) [ Time Frame: Week 12 after the treatment regimen change ]
    Difference in the proportion of target BP attainment at Week 12 between fimasartan and other ARB drugs (based on Korean Society of Hypertension clinical practice guidelines and ACC/AHA clinical practice guidelines, and the investigator's target BP)

  8. Descriptive statistics of BP (Systolic and Diastolic) [ Time Frame: 12 weeks ]
    Descriptive statistics of BP (analysis of the entire subjects and each sub-group)

  9. Drugs (antihypertensive, prior to study enrollment) [ Time Frame: at the time of study enrollment ]
    Information on antihypertensive drugs administered within 4 weeks prior to study enrollment (name of the drug, single agent/combination, and daily dose)

  10. Drugs (antihypertensive) [ Time Frame: 12 weeks ]
    Information on antihypertensive drugs used during the study period (name of the drug, single agent/combination, and daily dose)

  11. Drugs (antidiabetic, antidyslipidemic) [ Time Frame: 12 weeks ]
    Information on antidiabetic and antidyslipidemic drugs used during the study period (name of the drug, single agent/combination, and daily dose)


Other Outcome Measures:
  1. Incidence and characteristics of antihypertensive drug related adverse drug reactions [ Time Frame: 12 weeks ]
  2. Incidence of serious adverse events and serious adverse drug reactions [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with hypertension uncontrolled by antihypertensive drugs* whose antihypertensive regimens are changed to angiotensin receptor blocker (ARB) monotherapy or concomitant antihypertensive drug therapy containing ARB.

*Including patients who previously received angiotensin receptor blocker (ARB); in this case, changing to other therapy using an ARB with different ingredient is allowed.

Criteria

Inclusion Criteria:

  • Provided written consent to the use of personal information after receiving the explanation of the objective, methodology, etc. of this clinical study
  • Male or female adults ≥ 19 years who are diagnosed with essential hypertension
  • Receiving outpatient treatment at the time of study enrollment
  • Patients with hypertension uncontrolled by existing antihypertensive drugs (including ARB) whose antihypertensive regimens need to be changed to ARB monotherapy or ARB-containing combination therapy (the result of the arm with a higher mean BP [systolic BP preferred] when measured twice with at least a 2-minute interval in both arms at the medical office on the study enrollment date, will become the reference)

    • Definition of uncontrolled hypertension: Target BP (SBP <140 mmHg and DBP <90 mmHg) not achieved even after the treatment using the existing antihypertensive drugs for 4 weeks or longer

Exclusion Criteria:

  • Patients who were hospitalized or are scheduled to be hospitalized 4 weeks before or after the study enrollment date
  • Patients with suspected or confirmed secondary hypertension
  • Pregnant or breast-feeding women
  • Patients who received investigational product within 12 weeks or are scheduled to participate in another clinical study while participating in this study
  • Patients who are determined inappropriate for participating in the study by investigators for other reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649646


Contacts
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Contact: Myung Sook Hong 82-2-708-8238 mshong@boryung.co.kr

Locations
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Korea, Republic of
Ajou University Hospital Recruiting
Suwon, Korea, Republic of
Contact: Seung-Jae Tahk         
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Investigators
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Study Director: Myung Sook Hong Boryung Pharmaceutical Co., Ltd

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Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT03649646    
Other Study ID Numbers: BR-FMS-OS-404
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boryung Pharmaceutical Co., Ltd:
Hypertension
Fimasartan
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents