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

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.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemia

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)

• Study Type: Observational
• Enrollment (Actual): 3087

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

Diagnosed with hyperlipidemia including familial hypercholesterolemia and xanthoma.

Exclusion Criteria:

None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Probucol Tablets; Target is 3,000 patients in the Philippines diagnosed with hyperlipidemia (including familial hypercholesterolemia and xanthoma).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	values will be calculated at Day 30
Efficacy - Improvement in serum lipids.	Percentage changes in total cholesterol and triglycerides from	values will be calculated at Day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy - Changes in symptoms and vital signs.	Assessed by investigator using following scale: Markedly Improved; Improved; Slightly Improved; Unchanged; Aggravated; Unknown (not assessable)	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	overall 60 days

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical, Inc., Philippines

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: March 28, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: March 31, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: 009-PPA-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED