HyperlipidemiaPhase 2NCT00810979
Comparison of SLx-4090 Combined With Statin Therapy Versus Statin Alone in Reducing LDL-C in Patients With Hyperlipidemia
A Phase 2 study testing SLx-4090 and Statin in people with Hyperlipidemia, run by Response Pharmaceuticals at 19 sites in United States.
Trial summary
The purpose of this study is to determine whether SLx-4090 in combination with statin therapy will reduce LDL-C in patients with hyperlipidemia more effectively than statin therapy alone. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- SLx-4090 and Statin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 19 sitesUnited States
- Study dates
- Jan 2009to Sep 2009
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LDL-C > or = 100 mg/dL
- On stable statin therapy for at least 6 weeks
Who cannot join
- Coronary heart disease or risk factors for CHD
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Study site
Addison, Illinois, 60101
Study site
Atlanta, Georgia, 30342
Study site
Birmingham, Alabama, 35209
Study site
Chicago, Illinois, 60611
Study site
Chicago, Illinois, 60654
Study site
Cincinnati, Ohio, 45212
Study site
Cincinnati, Ohio, 45219
Study site
Cleveland, Ohio, 44122
Study site
Edina, Minnesota, 55435
Study site
Indianapolis, Indiana, 46260
Study site
Jacksonville, Florida, 32205
Study site
Louisville, Kentucky, 40213
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Raleigh, North Carolina, 27609
Study site
Richmond, Virginia, 23294
Study site
Rochester, New York, 14609
Study site
St Louis, Missouri, 63141
Study site
Tempe, Arizona, 85282
Study site
Tucson, Arizona, 85710
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Different Doses of SLx-4090 in Combination With a Statin vs. Statin Mono-therapy in Patients With Hyperlipidemia
The purpose of this study is to determine whether SLx-4090 in combination with statin therapy will reduce LDL-C in patients with hyperlipidemia more effectively than statin therapy alone.
Read the detailed description
- LDL-C after 12 weeks of treatment
- Safety and tolerability
- Plasma levels of SLx-4090
- Conditions
- Hyperlipidemia
- Being tested
- SLx-4090, Placebo, Statin
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLx-4090Drug
tablet
SLx-4090Drug
tablet
PlaceboOther
matching tablet
StatinDrug
Subjects were dosed with the statin prescribed specifically by their prescribing physician.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SLx-4090 dose #1 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician. Receives: Drug: SLx-4090; Drug: Statin |
| 2 | Experimental | SLx-4090 dose #2 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician. Receives: Drug: SLx-4090; Drug: Statin |
| 3 | Other | Placebo in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician. Receives: Other: Placebo; Drug: Statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in LDL-C
Measured: 12 weeks
Secondary outcomes (1)
Adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionSep 2009
- Study completionSep 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Response Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810979
- Sponsor's protocol ID
- SLx-4090-08-06
- Status last verified
- Apr 2023
- First submitted
- 17 Dec 2008
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Different Doses of SLx-4090 in Combination With a Statin vs. Statin Mono-therapy in Patients With Hyperlipidemia
- ClinicalTrials.gov ID
- NCT00810979
- Acronym / sponsor ID
- SLx-4090-08-06
- Conditions
- Hyperlipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Response PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 18 Dec 2008 (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 determine whether SLx-4090 in combination with statin therapy will reduce LDL-C in patients with hyperlipidemia more effectively than statin therapy alone.
Detailed description
- LDL-C after 12 weeks of treatment
- Safety and tolerability
- Plasma levels of SLx-4090
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SLx-4090, Drug: StatinSLx-4090 dose #1 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician. |
| 2 | Experimental | Drug: SLx-4090, Drug: StatinSLx-4090 dose #2 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician. |
| 3 | Other | Other: Placebo, Drug: StatinPlacebo in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- LDL-C > or = 100 mg/dL
- On stable statin therapy for at least 6 weeks
Key exclusion criteria (1 listed)
- Coronary heart disease or risk factors for CHD
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 |
|---|---|---|
| SLx-4090tablet | Drug | 1 |
| SLx-4090tablet | Drug | 2 |
| Placebomatching tablet | Other | 3 |
| StatinSubjects were dosed with the statin prescribed specifically by their prescribing physician. | Drug | 1, 2, 3 |
Primary outcome
Reduction in LDL-C
Time frame: 12 weeks
1 secondary outcome
Adverse events
Time frame: 12 weeks
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 18 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SLx-4090 and Statin in people with Hyperlipidemia, run by Response Pharmaceuticals at 19 sites in United States.
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 2 inclusion and 1 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Reduction in LDL-C (time frame: 12 weeks). 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 18 Nov 2023.