N/A
Completed N=4,542
FimasaRtan-basEd BP Targets After Drug SwitcHing
Source: ClinicalTrials.gov NCT03649646 ↗Enrolled (actual)
4,542
Serious AEs
0.4%
Results posted
Dec 2020
Primary outcomePrimary: Percentage of Patients With Controlled Blood Pressure (<140/90 mmHg) — 3083 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Controlled Blood Pressure (<140/90 mmHg) |
3083 | — |
| SECONDARY Percentage of Patients With Controlled BP According to 2018 KSH Guideline |
2353 | — |
| SECONDARY Percentage of Patients With Controlled BP According to 2017 ACC/AHA Guideline |
1454 | — |
| SECONDARY Prcentage of Patients With Controlled BP According to Investigator's Target BP |
1388 | — |
Eligibility 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 decided and scheduled 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
Data sourced from ClinicalTrials.gov (NCT03649646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.