HypertensionNCT03009721
Observational Study to Investigate the Effectiveness and Safety of Olostar Tab in Patients With Essential Hypertension and Dyslipidemia
An observational study of Hypertension and Dyslipidemias, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the effectiveness and safety of Olostar Tab in patients with essential hypertension and dyslipidemia Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Dyslipidemias
- What is being tested?
- Other: Not applicable-observational study
- How many people
- 9,707 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with essential hypertension and dyslipidemia
Who may be able to join
- Male or female ≥ 19
- Patients have record of blood pressure (SBP/DBP) and LDL-C after prescription of Olostar Tab.
Who cannot join
- Patients that have participated clinical trials or PMS with Olostar Tab.
Trial locations and contacts
1 site in 1 country.
Daewoong Clinical contact
South Korea1 site, 1 recruiting
- Recruiting
Dongguk Ilsan University Hospital
Ilsan
Daewoong Clinical
About this study
Official title: A Non-interventional, Multi-center, Retrospective Observational Study to Investigate the Effectiveness and Safety of Olostar Tab in Patients With Essential Hypertension and Dyslipidemia (ROSE Study)
The purpose of this study is to investigate the effectiveness and safety of Olostar Tab in patients with essential hypertension and dyslipidemia
- Conditions
- Hypertension, Dyslipidemias
- Being tested
- Other: Not applicable-observational study
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other: Not applicable-observational studyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in blood pressure (SBP/DBP)
Measured: At 8 Weeks
Percent change from baseline in LDL-Cholesterol (LDL-C)
Measured: At 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startAug 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 9,707 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009721
- Sponsor's protocol ID
- DW_DOLO003
- Status last verified
- Jan 2017
- First submitted
- 2 Jan 2017
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Multi-center, Retrospective Observational Study to Investigate the Effectiveness and Safety of Olostar Tab in Patients With Essential Hypertension and Dyslipidemia (ROSE Study)
- ClinicalTrials.gov ID
- NCT03009721
- Acronym / sponsor ID
- DW_DOLO003
- Conditions
- Hypertension, Dyslipidemias
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9,707 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effectiveness and safety of Olostar Tab in patients with essential hypertension and dyslipidemia
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with essential hypertension and dyslipidemia
Key inclusion criteria (2 listed)
- Male or female ≥ 19
- Patients have record of blood pressure (SBP/DBP) and LDL-C after prescription of Olostar Tab.
Key exclusion criteria (1 listed)
- Patients that have participated clinical trials or PMS with Olostar Tab.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other: Not applicable-observational study | Drug | – |
Primary outcome
Percent change from baseline in blood pressure (SBP/DBP)
Time frame: At 8 Weeks
Percent change from baseline in LDL-Cholesterol (LDL-C)
Time frame: At 8 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daewoong Clinical contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Dyslipidemias, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daewoong Clinical (+82-2-550-8800 ext. 8800), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in blood pressure (SBP/DBP) (time frame: At 8 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.