NCT02913794

Brief Summary

Fimasartan and Rosuvastatin for hypertension and dyslipidemia control

Trial Health

87
On Track

Trial Health Score

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

Enrollment
541

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

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

First Submitted

Initial submission to the registry

September 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

October 11, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2018

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

1.5 years

First QC Date

September 21, 2016

Last Update Submit

June 8, 2023

Conditions

Cardiovascular DiseasesHyperlipidemias

Outcome Measures

Primary Outcomes (1)

  • Co-relation between blood pressure and dyslipidemia

    Check the blood pressure and dyslipidemia control rates, also check the correlation between these two disease

    12 weeks

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1,056 patients

You may qualify if:

  • Hypertension patients who are taking an anti-hypertensive agent, including Fimasartan at least 12 weeks or more.
  • Dyslipidemia patients who are taking dyslipidemia drug, including Rosuvastatin at least 12 weeks or more
  • Patients who has blood pressure and lipid levels (Total cholesterol, LDL-C, HDL-C, non-HDL-C, \* TG) checks 2 weeks before registration

You may not qualify if:

  • Patients being hospitalized
  • Patients who stop taking Fimasartan or Rosuvastatin within 12 weeks 14 or more consecutive days
  • Patients who have more than 400mg/dl triglyceride(TG) at the registration time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Cardiovascular DiseasesHyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Hyung-Jin Jung

    Boryung Pharmaceutical Co., Ltd

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2016

First Posted

September 26, 2016

Study Start

October 11, 2016

Primary Completion

March 29, 2018

Study Completion

March 29, 2018

Last Updated

June 12, 2023

Record last verified: 2023-06

Locations

KR(1)