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CompletedNCT02730390Updated Apr 6, 2016

Study on the Efficacy and Safety of Oral Probucol Tablets in Patients With Hyperlipidemia - Post-Marketing Surveillance

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,087
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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

  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)
02

Conditions studied

  • Hyperlipidemia
03

In context

Hyperlipidemias

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A total of 3,000 patients in the Philippines with hyperlipidemia (including familial hypercholesterolemia and xanthoma).

Inclusion criteria

Diagnosed with hyperlipidemia including familial hypercholesterolemia and xanthoma.

Exclusion criteria

Exclusion Criteria:

None

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,087 participants (actual)

Groups and cohorts

  • Probucol Tablets

    Target is 3,000 patients in the Philippines diagnosed with hyperlipidemia (including familial hypercholesterolemia and xanthoma).

06

What researchers measure

Primary outcomes

  1. 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

  2. Efficacy - Improvement in serum lipids.

    Percentage changes in total cholesterol and triglycerides from

    Time frame: values will be calculated at Day 60

Secondary outcomes

  1. 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

  2. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02730390
Lead sponsor
Otsuka Pharmaceutical, Inc., Philippines
Responsible party
Sponsor
First posted
Apr 6, 2016
Start date
Dec 2009
Primary completion
Jul 2013
Completion
Aug 2013
Last update
Apr 6, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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