HyperlipidemiaNCT02730390
Study on the Efficacy and Safety of Oral Probucol Tablets in Patients With Hyperlipidemia - Post-Marketing Surveillance
An observational study of Hyperlipidemia, run by Otsuka Pharmaceutical, Inc., Philippines.
Trial summary
The primary objective of this post marketing surveillance (PMS) is to determine the safety and efficacy of probucol in lowering the level of serum cholesterol in the blood. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperlipidemia
- How many people
- 3,087 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Aug 2013
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 3,000 patients in the Philippines with hyperlipidemia (including familial hypercholesterolemia and xanthoma).
Who may be able to join
- Diagnosed with hyperlipidemia including familial hypercholesterolemia and xanthoma.
Who cannot join
- None
About this study
The primary objective of this post marketing surveillance (PMS) is to determine the safety and efficacy of probucol in lowering the level of serum cholesterol in the blood.
Read the detailed description
This nationwide post marketing surveillance targets to recruit a total of 3,000 patients with hyperlipidemia. Duration of treatment is 60 days. The usual starting dose for Lorelco is 500 mg administered daily, divided into two (2) doses (250mg BID) and given after meals. The dose may be adjusted according to the patient's age and condition. Lipid serum test will be obtained at Day 0 (Baseline). In subjects requiring antihyperlipidemics that fulfill the inclusion criteria, Lorelco 250 BID will be started. There will be 2 follow-up visits after baseline on Day 30 and Day 60. Both lipid serum tests and ECG will be done on these 2 follow-up visits. During each visit the investigator will assess the subject's vital signs and symptoms and check for any adverse events.
The primary outcome of measure is the percentage reduction or increase in total cholesterol and triglycerides from baseline values at Week 0 to Week 4 and Week 8 using the following scale:
Total Cholesterol Triglycerides
- Markedly reduced
- Moderately reduced
- Slightly reduced
- Unchanged
- Increased Reduction of ≥ 15% Reduction of ≥ 10% but < 15% Reduction of ≥ 5% but < 10% Change of < 5% Increase of ≥ 5% Reduction of ≥ 30% Reduction of ≥ 20% but < 30% Reduction of ≥ 10% but < 20% Change of < 10% Increase of ≥ 10% The percentage change on the last week of treatment will be the final evaluation.
The secondary outcome is measured by the changes in symptoms and vital signs. Using the following scale:
- Markedly Improved
- Improved
- Slightly Improved
- Unchanged
- Aggravated
- Unknown (not assessable)
Safety will be measured by the incidence of adverse events to be collected.
Overall efficacy and safety will be evaluated to assess the usefulness of Lorelco using the following scale:
- Very useful
- Useful
- Somewhat useful
- Not useful
- Unfavorable
- Unknown (not assessable)
- Conditions
- Hyperlipidemia
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Probucol Tablets | Target is 3,000 patients in the Philippines diagnosed with hyperlipidemia (including familial hypercholesterolemia and xanthoma). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Improvement in serum lipids.
Percentage changes in total cholesterol and triglycerides from baseline (Day 0) values will be calculated at Day 30 and Day 60.
Measured: values will be calculated at Day 30
Efficacy - Improvement in serum lipids.
Percentage changes in total cholesterol and triglycerides from
Measured: values will be calculated at Day 60
Secondary outcomes (2)
Efficacy - Changes in symptoms and vital signs.
Assessed by investigator using following scale:
- Markedly Improved
- Improved
- Slightly Improved
- Unchanged
- Aggravated
- Unknown (not assessable)
Measured: overall 60 days
Safety - Overall Safety will be evaluated to assess the usefulness of the study drug
Check for any adverse event and assess the usefulness
Measured: overall 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startDec 2009
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- 3,087 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical, Inc., Philippines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730390
- Sponsor's protocol ID
- 009-PPA-1001
- Status last verified
- Mar 2016
- First submitted
- 28 Mar 2016
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of Oral Probucol Tablets in Patients With Hyperlipidemia - Post-Marketing Surveillance
- ClinicalTrials.gov ID
- NCT02730390
- Acronym / sponsor ID
- 009-PPA-1001
- Conditions
- Hyperlipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,087 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical, Inc., PhilippinesIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 6 Apr 2016 (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 primary objective of this post marketing surveillance (PMS) is to determine the safety and efficacy of probucol in lowering the level of serum cholesterol in the blood.
Detailed description
This nationwide post marketing surveillance targets to recruit a total of 3,000 patients with hyperlipidemia. Duration of treatment is 60 days. The usual starting dose for Lorelco is 500 mg administered daily, divided into two (2) doses (250mg BID) and given after meals. The dose may be adjusted according to the patient's age and condition. Lipid serum test will be obtained at Day 0 (Baseline). In subjects requiring antihyperlipidemics that fulfill the inclusion criteria, Lorelco 250 BID will be started. There will be 2 follow-up visits after baseline on Day 30 and Day 60. Both lipid serum tests and ECG will be done on these 2 follow-up visits. During each visit the investigator will assess the subject's vital signs and symptoms and check for any adverse events.
The primary outcome of measure is the percentage reduction or increase in total cholesterol and triglycerides from baseline values at Week 0 to Week 4 and Week 8 using the following scale:
Total Cholesterol Triglycerides
- Markedly reduced
- Moderately reduced
- Slightly reduced
- Unchanged
- Increased Reduction of ≥ 15% Reduction of ≥ 10% but < 15% Reduction of ≥ 5% but < 10% Change of < 5% Increase of ≥ 5% Reduction of ≥ 30% Reduction of ≥ 20% but < 30% Reduction of ≥ 10% but < 20% Change of < 10% Increase of ≥ 10% The percentage change on the last week of treatment will be the final evaluation.
The secondary outcome is measured by the changes in symptoms and vital signs. Using the following scale:
- Markedly Improved
- Improved
- Slightly Improved
- Unchanged
- Aggravated
- Unknown (not assessable)
Safety will be measured by the incidence of adverse events to be collected.
Overall efficacy and safety will be evaluated to assess the usefulness of Lorelco using the following scale:
- Very useful
- Useful
- Somewhat useful
- Not useful
- Unfavorable
- Unknown (not assessable)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probucol Tablets | – | –Target is 3,000 patients in the Philippines diagnosed with hyperlipidemia (including familial hypercholesterolemia and xanthoma). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 3,000 patients in the Philippines with hyperlipidemia (including familial hypercholesterolemia and xanthoma).
Key inclusion criteria (1 listed)
- Diagnosed with hyperlipidemia including familial hypercholesterolemia and xanthoma.
Key exclusion criteria (1 listed)
- None
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
Efficacy - Improvement in serum lipids.
Time frame: values will be calculated at Day 30
Percentage changes in total cholesterol and triglycerides from baseline (Day 0) values will be calculated at Day 30 and Day 60.
Efficacy - Improvement in serum lipids.
Time frame: values will be calculated at Day 60
Percentage changes in total cholesterol and triglycerides from
2 secondary outcomes
Efficacy - Changes in symptoms and vital signs.
Time frame: overall 60 days
Safety - Overall Safety will be evaluated to assess the usefulness of the study drug
Time frame: overall 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Hyperlipidemia
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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 Hyperlipidemia, run by Otsuka Pharmaceutical, Inc., Philippines.
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 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: finished, as of the sponsor's last update on 6 Apr 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy - Improvement in serum lipids. (time frame: values will be calculated at Day 30). 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 6 Apr 2016.