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

Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730390
• Other study ID #: 009-PPA-1001
• Status: Completed
• Phase: Phase 4
• First received: March 28, 2016
• Last updated: March 31, 2016
• Start date: December 2009
• Est. completion date: August 2013

Study information

• Verified date: March 2016
• Source: Otsuka Pharmaceutical, Inc., Philippines
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and DrugsPhilippines: Department of Health
• Study type: Observational

Clinical 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3087
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Diagnosed with hyperlipidemia including familial hypercholesterolemia and xanthoma.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical, Inc., Philippines

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Efficacy - Improvement in serum lipids.	Percentage changes in total cholesterol and triglycerides from	values will be calculated at Day 60	No
Secondary	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	No
Secondary	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	No