Clinical trial NCT02730390: Study on the Efficacy and Safety of Oral Probucol Tablets in Patients With Hyperlipidemia - Post-Marketing Surveillance
Official title: Study on the Efficacy and Safety of Oral Probucol Tablets in Patients With Hyperlipidemia - Post-Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperlipidemia
Lead sponsor: Otsuka Pharmaceutical, Inc., Philippines
Sponsor class: INDUSTRY
First posted: 2016-04-06
Enrollment: 3087
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 3,000 patients in the Philippines with hyperlipidemia (including familial hypercholesterolemia and xanthoma).

Brief 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.

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

1. Markedly reduced
2. Moderately reduced
3. Slightly reduced
4. Unchanged
5. 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:

1. Markedly Improved
2. Improved
3. Slightly Improved
4. Unchanged
5. Aggravated
6. 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:

1. Very useful
2. Useful
3. Somewhat useful
4. Not useful
5. Unfavorable
6. Unknown (not assessable)

Eligibility criteria: Inclusion Criteria:

Diagnosed with hyperlipidemia including familial hypercholesterolemia and xanthoma.

Exclusion Criteria:

None

Primary outcomes:
measure: Efficacy - Improvement in serum lipids.
timeFrame: values will be calculated at Day 30
measure: Efficacy - Improvement in serum lipids.
timeFrame: values will be calculated at Day 60
Secondary outcomes:
measure: Efficacy - Changes in symptoms and vital signs.
timeFrame: overall 60 days
measure: Safety - Overall Safety will be evaluated to assess the usefulness of the study drug
timeFrame: overall 60 days
Other outcomes:
Locations:
Study officials:
References: