HyperlipidemiaPhase 3NCT01349010
Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia
A Phase 3 study testing Probucol in people with Hyperlipidemia, run by Otsuka Beijing Research Institute at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of imported Probucol in hyperlipidemia patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Probucol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to Feb 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing Informed Content Form;
- Age >= 20 (the age at the time of signing ICF; both gender);
- hyperlipidemia patients who meet the following criteria:
- 4.14 mmol/L (160mg/dL) =< LDL-C (Serum low density lipoprotein-cholesterol) < 6 mmol/L (232mg/dL)
- TG (Serum triglycerides) < 4.5 mmol/L (398mg/dL);
- Framingham: Coronary Heart Disease 2-year risk probabilities < 10%.
Who cannot join
- Subjects who receive antilipemic agents within 1 month prior to the pre-screening period;
- Subjects who receive Probucol within 6 months prior to the pre-screening period;
- Coronary Heart Disease subjects;
- Subjects being treated with cyclosporine;
- Subjects with a history of hypersensitivity to Probucol;
- QTc interval > 450ms (male); QTc interval > 470ms (female);
Show all 12Show fewer
- Subjects with impaired hepatic and renal function, who meet any of the following abnormal value:
- AST >= 100IU/L
- ALT >= 100IU/L
- Serum creatinine >= 1.5mg/dL
- Female subjects who are pregnant, lactating, or who plan to conceive;
- Subjects who are considered by the investigator to be inappropriate to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The Sencond Xiangya Hospital of Central South University
Changsha, Hunan, 410011
About this study
Official title: A Randomized, Double Blind, Placebo Control, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Imported Probucol in Hyperlipidemia Patients
The purpose of this study is to evaluate the efficacy and safety of imported Probucol in hyperlipidemia patients.
Read the detailed description
This is a randomized, double blind, placebo control, multi-centre clinical study in hyperlipidemia patients.
Enrolled subjects will be randomized to the treatment group or control group, and receive Probucol or placebo continuously for 8 weeks; Treatment group: Imported Probucol 250 mg (1 tablet) bid. p.o Control group: Placebo 1 tablet bid. p.o
- Conditions
- Hyperlipidemia
- Being tested
- Probucol, Placebo
- Keywords
- hyperlipidemia
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbucolDrug
Also called Lorelco
250mg (1 tablet) bid. p.o for 8 weeks
PlaceboDrug
1 tablet bid. p.o for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Arm: Placebo 1 tablet bid. p.o Receives: Drug: Placebo |
| Probucol | Active comparator | Probucol Arm: Imported Probucol 250 mg (1 tablet) bid. p.o Receives: Drug: Probucol |
What is being measured
The primary outcome is the main question the study is designed to answer.
TC and LDL-C
Changes of TC and LDL-C from the baseline after 8-week treatment;
Measured: 8-week
Secondary outcomes (1)
oxLDL and MCP-1
Changes of oxLDL and MCP-1 from the baseline after 8-week treatment;
Measured: 8-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shuiping Zhao, MD, Principal investigator, The Sencond Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349010
- Sponsor's protocol ID
- 009-10-802-01
- Status last verified
- Jun 2013
- First submitted
- 24 Mar 2011
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Control, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Imported Probucol in Hyperlipidemia Patients
- ClinicalTrials.gov ID
- NCT01349010
- Acronym / sponsor ID
- 009-10-802-01
- Conditions
- Hyperlipidemia
- Keywords
- hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 6 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of imported Probucol in hyperlipidemia patients.
Detailed description
This is a randomized, double blind, placebo control, multi-centre clinical study in hyperlipidemia patients.
Enrolled subjects will be randomized to the treatment group or control group, and receive Probucol or placebo continuously for 8 weeks; Treatment group: Imported Probucol 250 mg (1 tablet) bid. p.o Control group: Placebo 1 tablet bid. p.o
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Arm: Placebo 1 tablet bid. p.o |
| Probucol | Active comparator | Drug: ProbucolProbucol Arm: Imported Probucol 250 mg (1 tablet) bid. p.o |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signing Informed Content Form;
- Age >= 20 (the age at the time of signing ICF; both gender);
- hyperlipidemia patients who meet the following criteria:
- Framingham: Coronary Heart Disease 2-year risk probabilities < 10%.
Key exclusion criteria (12 listed)
- Subjects who receive antilipemic agents within 1 month prior to the pre-screening period;
- Subjects who receive Probucol within 6 months prior to the pre-screening period;
- Coronary Heart Disease subjects;
- Subjects being treated with cyclosporine;
- Subjects with a history of hypersensitivity to Probucol;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbucolAlso: Lorelco250mg (1 tablet) bid. p.o for 8 weeks | Drug | Probucol |
| Placebo1 tablet bid. p.o for 8 weeks | Drug | Placebo |
Primary outcome
TC and LDL-C
Time frame: 8-week
Changes of TC and LDL-C from the baseline after 8-week treatment;
1 secondary outcome
oxLDL and MCP-1
Time frame: 8-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuiping Zhao, MD principal investigator
The Sencond Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probucol in people with Hyperlipidemia, run by Otsuka Beijing Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TC and LDL-C (time frame: 8-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013.