NCT03009721

Brief Summary

The purpose of this study is to investigate the effectiveness and safety of Olostar Tab in patients with essential hypertension and dyslipidemia

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
9,707

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

January 2, 2017

Last Update Submit

January 3, 2017

Conditions

HypertensionDyslipidemias

Outcome Measures

Primary Outcomes (2)

  • Percent change from baseline in blood pressure (SBP/DBP)

    At 8 Weeks

  • Percent change from baseline in LDL-Cholesterol (LDL-C)

    At 8 Weeks

Interventions

Other: Not applicable-observational studyDRUG

Eligibility Criteria

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

Patients with essential hypertension and dyslipidemia

You may qualify if:

  • Male or female ≥ 19
  • Patients have record of blood pressure (SBP/DBP) and LDL-C after prescription of Olostar Tab.

You may not qualify if:

  • Patients that have participated clinical trials or PMS with Olostar Tab.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongguk Ilsan University Hospital

Ilsan, South Korea

RECRUITING

MeSH Terms

Conditions

HypertensionDyslipidemias

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Daewoong Clinical

CONTACT

+82-2-550-8800

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2017

First Posted

January 4, 2017

Study Start

August 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

January 4, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)