DyslipidaemiasPhase 2NCT00169559
Dyslipidemia Study Investigating The Increase In "Good Cholesterol"
A Phase 2 study testing GW590735 and fenofibrate in people with Dyslipidaemias, run by GlaxoSmithKline at 50 sites in 2 countries.
Trial summary
An eight week comparison of the investigational drug GW590735, placebo, and the marketed drug fenofibrate intended to increase the levels of "good cholesterol" and decrease levels of "bad cholesterol" in healthy patients with low levels of good cholesterol and high levels of bad cholesterol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidaemias
- What is being tested?
- GW590735 and fenofibrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 50 sitesin 2 countries
- Study dates
- Nov 2003to Apr 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High-density lipoprotein cholesterol less than or equal to 45 mg/dL.
- Triglycerides greater than or equal to 120 mg/dL and less than or equal to 500 mg/dL.
- Women must be surgically sterile or postmenopausal.
Who cannot join
- Heart disease
- Diabetes
Trial locations and contacts
50 sites in 2 countries.
50 sites in 2 countries
United States45 sites
GSK Investigational Site
Allentown, Pennsylvania, 18102
GSK Investigational Site
Auburn, Maine, 04210
GSK Investigational Site
Beverly Hills, California, 90210
GSK Investigational Site
Birmingham, Alabama, 35243
GSK Investigational Site
Bristol, Tennessee, 37620
GSK Investigational Site
Brooklyn Center, Minnesota, 55430
GSK Investigational Site
Bryan, Texas, 77802
GSK Investigational Site
Cincinnati, Ohio, 45219
GSK Investigational Site
Cincinnati, Ohio, 45246
GSK Investigational Site
Conroe, Texas, 77304
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Endwell, New York, 13760
GSK Investigational Site
Erie, Pennsylvania, 16506
GSK Investigational Site
Evansville, Indiana, 47714
GSK Investigational Site
Fort Lauderale, Florida, 33308
GSK Investigational Site
Fort Lauderdale, Florida, 33145
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Healdsburg, California, 95448
GSK Investigational Site
Hollywood, Florida, 33021
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Indianapolis, Indiana, 46260
GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
Jacksonville, Florida, 32205
GSK Investigational Site
Jacksonville, Florida, 32216
GSK Investigational Site
Kingsport, Tennessee, 37660
GSK Investigational Site
Louisville, Kentucky, 40213
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
Norfolk, Virginia, 23502
GSK Investigational Site
Omaha, Nebraska, 68131
GSK Investigational Site
Orange, California, 92868
GSK Investigational Site
Orland Park, Illinois, 60462
GSK Investigational Site
Pembroke Pines, Florida, 33024
GSK Investigational Site
Phoenix, Arizona, 85014
GSK Investigational Site
Phoenix, Arizona, 85050
GSK Investigational Site
Richmond, Virginia, 23294
GSK Investigational Site
Rochester, New York, 14609
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Scottsdale, Arizona, 85251
GSK Investigational Site
Sioux Falls, South Dakota, 57105
GSK Investigational Site
Spring Valley, California, 91978
GSK Investigational Site
Statesville, North Carolina, 28677
GSK Investigational Site
Walnut Creek, California, 94598
GSK Investigational Site
Williamsville, New York, 14221
GSK Investigational Site
Wilmington, North Carolina, 28412
Canada5 sites
GSK Investigational Site
Calgary, Alberta, T2E 7C5
GSK Investigational Site
Laval, Quebec, H7V 2T8
GSK Investigational Site
Québec, Quebec, G1V 4M6
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G2
GSK Investigational Site
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: A Multi-center, Three-staged, Randomized, Parallel Group, Sequential, Double-blind, fenofibrate-and Placebo-controlled Dose-response Evaluation of the Safety, Tolerability, and Effects on Plasma HDLc and TG of Eight Weeks Treatment With 1µg to 20µg Daily Doses of GW590735 in Otherwise Healthy Subjects With Low HDLc, Mildly to Moderately Elevated TG, and Normal LDLc
An eight week comparison of the investigational drug GW590735, placebo, and the marketed drug fenofibrate intended to increase the levels of "good cholesterol" and decrease levels of "bad cholesterol" in healthy patients with low levels of good cholesterol and high levels of bad cholesterol.
Read the detailed description
A multi-center, three-staged, randomized, parallel group, sequential, double-blind, fenofibrate-and placebo-controlled dose-response evaluation of the safety, tolerability, and effects on plasma HDLc and TG of eight weeks treatment with 1µg to 20µg daily doses of GW590735 in otherwise healthy subjects with low HDLc, mildly to moderately elevated TG, and normal LDLc
- Conditions
- Dyslipidaemias
- Being tested
- GW590735, fenofibrate
- Keywords
- triglycerides, Hypertriglyceridemia, cholesterol, LDL, HDL
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW590735Drug
1µg to 20µg daily doses of GW590735
fenofibrateDrug
Marketed Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | Placebo Receives: Drug: GW590735; Drug: fenofibrate |
| Arm 2 | Active comparator | Fenofibrate Receives: Drug: GW590735 |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in fasting plasma HDLc concentration at the end of eight weeks of double blind treatment
Measured: 8 weeks
Secondary outcomes (1)
changes from baseline in: fasting plasma total cholesterol, TG, LDLc, ApoA1, ApoA2, Lipoprotein containing ApoA1 and not ApoA2, Lipoprotein containing both ApoA1 and ApoA2, Apo B100, Apo CIII, Free Fatty Acid, insulin, fibrinogen, and C-reactive protein
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startNov 2003
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidaemiasStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169559
- Sponsor's protocol ID
- PAA20001
- Status last verified
- Oct 2012
- First submitted
- 9 Sep 2005
- Last updated
- 22 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Three-staged, Randomized, Parallel Group, Sequential, Double-blind, fenofibrate-and Placebo-controlled Dose-response Evaluation of the Safety, Tolerability, and Effects on Plasma HDLc and TG of Eight Weeks Treatment With 1µg to 20µg Daily Doses of GW590735 in Otherwise Healthy Subjects With Low HDLc, Mildly to Moderately Elevated TG, and Normal LDLc
- ClinicalTrials.gov ID
- NCT00169559
- Acronym / sponsor ID
- PAA20001
- Conditions
- Dyslipidaemias
- Keywords
- triglycerides, Hypertriglyceridemia, cholesterol, LDL, HDL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 15 Sep 2005 (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.
An eight week comparison of the investigational drug GW590735, placebo, and the marketed drug fenofibrate intended to increase the levels of "good cholesterol" and decrease levels of "bad cholesterol" in healthy patients with low levels of good cholesterol and high levels of bad cholesterol.
Detailed description
A multi-center, three-staged, randomized, parallel group, sequential, double-blind, fenofibrate-and placebo-controlled dose-response evaluation of the safety, tolerability, and effects on plasma HDLc and TG of eight weeks treatment with 1µg to 20µg daily doses of GW590735 in otherwise healthy subjects with low HDLc, mildly to moderately elevated TG, and normal LDLc
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: GW590735, Drug: fenofibratePlacebo |
| Arm 2 | Active comparator | Drug: GW590735Fenofibrate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- High-density lipoprotein cholesterol less than or equal to 45 mg/dL.
- Triglycerides greater than or equal to 120 mg/dL and less than or equal to 500 mg/dL.
- Women must be surgically sterile or postmenopausal.
Key exclusion criteria (2 listed)
- Heart disease
- Diabetes
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 |
|---|---|---|
| GW5907351µg to 20µg daily doses of GW590735 | Drug | Arm 1, Arm 2 |
| fenofibrateMarketed Drug | Drug | Arm 1 |
Primary outcome
change from baseline in fasting plasma HDLc concentration at the end of eight weeks of double blind treatment
Time frame: 8 weeks
1 secondary outcome
changes from baseline in: fasting plasma total cholesterol, TG, LDLc, ApoA1, ApoA2, Lipoprotein containing ApoA1 and not ApoA2, Lipoprotein containing both ApoA1 and ApoA2, Apo B100, Apo CIII, Free Fatty Acid, insulin, fibrinogen, and C-reactive protein
Time frame: 8 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 22 Oct 2012.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
50 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW590735 and fenofibrate in people with Dyslipidaemias, run by GlaxoSmithKline at 50 sites in 2 countries.
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 3 inclusion and 2 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 22 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Canada. 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 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?
change from baseline in fasting plasma HDLc concentration at the end of eight weeks of double blind treatment (time frame: 8 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 22 Oct 2012.