An observational study in Hyperlipidemia, sponsored by Otsuka Pharmaceutical, Inc., Philippines. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-04-06.
Sponsored by Otsuka Pharmaceutical, Inc., Philippines · Observational
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.
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
The secondary outcome is measured by the changes in symptoms and vital signs. Using the following scale:
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:
821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.
This study's enrollment of 3,087 is above the median of 302 across 101 observational studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →Otsuka Pharmaceutical, Inc., Philippines is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
A total of 3,000 patients in the Philippines with hyperlipidemia (including familial hypercholesterolemia and xanthoma).
Diagnosed with hyperlipidemia including familial hypercholesterolemia and xanthoma.
Exclusion Criteria:
None
Target is 3,000 patients in the Philippines diagnosed with hyperlipidemia (including familial hypercholesterolemia and xanthoma).
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.
Time frame: values will be calculated at Day 30
Efficacy - Improvement in serum lipids.
Percentage changes in total cholesterol and triglycerides from
Time frame: values will be calculated at Day 60
Efficacy - Changes in symptoms and vital signs.
Assessed by investigator using following scale: 1. Markedly Improved 2. Improved 3. Slightly Improved 4. Unchanged 5. Aggravated 6. Unknown (not assessable)
Time frame: 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
Time frame: overall 60 days
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Otsuka Pharmaceutical, Inc., Philippines