Fimasartan and Rosuvastatin for Hypertension and Dyslipid... | NCT02913794

Studies
Fimasartan and Rosuvastatin for Hypertension and Dyslipidemia Control

NCT02913794

Sponsor

Boryung Pharmaceutical Co., Ltd

Status

Completed

Last Update Posted

Jun 12, 2023Actual

Enrollment

541Actual

Phase

Not provided

Conditions

Cardiovascular Diseases
Hyperlipidemias

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 11, 2016Actual

Primary Completion Date

Mar 29, 2018Actual

Completion Date

Mar 29, 2018Actual

First Submitted Date

Sep 21, 2016

First Submission Date that Met QC Criteria

Sep 22, 2016

First Posted Date

Sep 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2023

Last Update Posted Date

Jun 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

541Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

1,056 patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hyung-Jin Jung	Boryung Pharmaceutical Co., Ltd	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
D006949	Hyperlipidemias

Ancestor Terms

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided