NCT02394392

Brief Summary

  1. 1.Investigate the clinical characteristics, medication satisfaction and quality of life of anti-hypertensive drugs in Korean hypertensive patients
  2. 2.Observe the changes of medication satisfaction and compliance in patients after switchting to Fimasartan

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,691

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

1.1 years

First QC Date

March 10, 2015

Last Update Submit

July 7, 2016

Conditions

Keywords

Medication satisfactionQuality of lifeDrug compliance

Outcome Measures

Primary Outcomes (2)

  • quality of life questionnaire for hypertension

    up to 1 month

  • medication satisfaction questionnaire

    up to 8 weeks

Secondary Outcomes (1)

  • Drug compliance questionnaire

    up to 8 weeks

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

14,000 hypertensive patients anticipated 30% of hypertensive patients who does not satisfied their anti-hypertensive drugs

You may qualify if:

  • Step1
  • Over 20 years old
  • Essential hypertensive patients who taking anti-hypertensive drugs during previous 1 month
  • Step2
  • Patients does not taking Fimasartan
  • Patient's medication satisfaction score under 4

You may not qualify if:

  • Patients with secondary hypertension
  • Patients with orthostatic hypotension who has sign and symptom
  • Patients with known severe or malignancy retinopathy
  • Patients with significant investigations; abnormal renal function
  • Childbearing and breast-feeding women
  • Patients with history of allergic reaction to any angiotensin II antagonist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea university Guro hospital

Seoul, South Korea

Location

Related Publications (1)

  • Oh DJ, Han SE, Jeong SH, Hong MS, Choe SC. Clinical characteristics and satisfaction with the fimasartan in Korean hypertensive patients: a prospective, cross-sectional and open-label, 8-week switching study (Kanarb-hypertension epidemiology medication satisfaction study; K-HEMS study). Clin Hypertens. 2018 Sep 1;24:10. doi: 10.1186/s40885-018-0096-2. eCollection 2018.

MeSH Terms

Conditions

HypertensionMedication Adherence

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 20, 2015

Study Start

July 1, 2014

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations