NCT02730390

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,087

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2009

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
Last Updated

April 6, 2016

Status Verified

March 1, 2016

Enrollment Period

3.6 years

First QC Date

March 28, 2016

Last Update Submit

March 31, 2016

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Efficacy - Changes in symptoms and vital signs.

    overall 60 days

  • Safety - Overall Safety will be evaluated to assess the usefulness of the study drug

    overall 60 days

Study Arms (1)

Probucol Tablets

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Diagnosed with hyperlipidemia including familial hypercholesterolemia and xanthoma.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2016

First Posted

April 6, 2016

Study Start

December 1, 2009

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

April 6, 2016

Record last verified: 2016-03