HypertensionNCT03742544
Post Marketing Surveillance of Telostop TAB (Telmisartan/Rosuvastatin) for Evaluating the Safety and Efficacy
An observational study of Hypertension and Dyslipidemias, run by IlDong Pharmaceutical Co Ltd.
Trial summary
Post-marketing surveillance of Telostop TAB (Telmisartan/Rosuvastatin) Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Dyslipidemias
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 23 Jun 2015to 30 Oct 2020
- 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: residents of Korea, in real-world practice
Who may be able to join
- The patient who is first prescribed and administered Telostop plus Tab.
Who cannot join
- The patients who are overreacting to this drug or its components
- The patients to the "Do not administer to the next patient" section of the approved instructions for use
About this study
Post-marketing surveillance of Telostop TAB (Telmisartan/Rosuvastatin)
Read the detailed description
Telostop TAB is fixed-dose combination of telmisartan and rosuvastatin, which was approved in 2015 in the Republic of Korea for the treatment of patients with hypertention and dyslipidemia. A post-marketing surveillance was conducted following the approval to obtain data on the safety and efficacy of Telostop TAB in real-world practice.
- Conditions
- Hypertension, Dyslipidemias
- Medical subject headings
- Hypertension, Dyslipidemias
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse event after this drug administration in general medical practice
Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period.
Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events.
Measured: 24 weeks
Secondary outcomes (2)
The change from baseline to week 24 in the LDL cholesterol
LDL cholesterol is measured before administration of the drug and within 24 weeks after administration.
Measured: 24 weeks
The change from baseline to week 24 in the blood pressure
Blood pressure is measured before administration of the drug and within 24 weeks after administration.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start23 Jun 2015
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Oct 2020 (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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742544
- Sponsor's protocol ID
- ID-TERO-401
- Status last verified
- Nov 2018
- First submitted
- 12 Nov 2018
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance of Telostop TAB (Telmisartan/Rosuvastatin) for Evaluating the Safety and Efficacy
- ClinicalTrials.gov ID
- NCT03742544
- Acronym / sponsor ID
- ID-TERO-401
- Conditions
- Hypertension, Dyslipidemias
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2015 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 15 Nov 2018 (actual)
- 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.
Post-marketing surveillance of Telostop TAB (Telmisartan/Rosuvastatin)
Detailed description
Telostop TAB is fixed-dose combination of telmisartan and rosuvastatin, which was approved in 2015 in the Republic of Korea for the treatment of patients with hypertention and dyslipidemia. A post-marketing surveillance was conducted following the approval to obtain data on the safety and efficacy of Telostop TAB in real-world practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- residents of Korea, in real-world practice
Key inclusion criteria (1 listed)
- The patient who is first prescribed and administered Telostop plus Tab.
Key exclusion criteria (2 listed)
- The patients who are overreacting to this drug or its components
- The patients to the "Do not administer to the next patient" section of the approved instructions for use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of adverse event after this drug administration in general medical practice
Time frame: 24 weeks
Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events.
2 secondary outcomes
The change from baseline to week 24 in the LDL cholesterol
Time frame: 24 weeks
The change from baseline to week 24 in the blood pressure
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Dyslipidemias, run by IlDong Pharmaceutical Co Ltd.
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 1 inclusion and 2 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 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse event after this drug administration in general medical practice (time frame: 24 weeks). 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 15 Nov 2018.