Hyperlipidemia Clinical Trial
Official title:
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.
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: |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Otsuka Pharmaceutical, Inc., Philippines |
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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