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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02730390
Other study ID # 009-PPA-1001
Secondary ID
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


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
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