DyslipidaemiasPhase 2NCT00158899
GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol
A Phase 2 study testing GW501516 oral tablets in people with Dyslipidaemias and Dyslipidaemia, run by GlaxoSmithKline at 64 sites in 11 countries.
Trial summary
The purpose of this clinical research study is to compare up to 3 doses of an investigational drug GW501516 to placebo (an inactive pill that looks like GW501516) to see if it is safe, well tolerated and effective in improving (raising) low levels of "good cholesterol", high-density lipoprotein cholesterol (HDLc), as… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyslipidaemias, Dyslipidaemia
- What is being tested?
- GW501516 oral tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 424 participants
- Where
- 64 sitesin 11 countries
- Study dates
- Aug 2004to Jun 2006
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a fasting plasma HDLc concentration <=45mg/dL (<=1.16mmol/L), plasma LDLc levels that do not require treatment according to the National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATPÂ III) guidelines.
- Have a fasting plasma TG concentration =500mg/dL (=5.65mmol/L).
Who cannot join
- Coronary heart disease.
- Diabetes mellitus.
- Atherosclerotic disease.
Trial locations and contacts
64 sites in 11 countries.
64 sites in 11 countries
Germany27 sites
GSK Investigational Site
Beckum, North Rhine-Westphalia, 59269
GSK Investigational Site
Berlin, 10117
GSK Investigational Site
Berlin, 10559
GSK Investigational Site
Berlin, 10787
GSK Investigational Site
Berlin, 12524
GSK Investigational Site
Berlin, 13055
GSK Investigational Site
Berlin, 13125
GSK Investigational Site
Berlin, 13158
GSK Investigational Site
Berlin, 13347
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069
GSK Investigational Site
Gelnhausen, Hesse, 63571
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574
GSK Investigational Site
Haag, Bavaria, 83527
GSK Investigational Site
Hamburg, 20246
GSK Investigational Site
Hamburg, 22525
GSK Investigational Site
Höhenkirchen-Siegertsbrunn, Bavaria, 85635
GSK Investigational Site
Koenigslutter, Lower Saxony, 38154
GSK Investigational Site
Leipzig, Saxony, 04103
GSK Investigational Site
Leipzig, Saxony, 04107
GSK Investigational Site
Leipzig, Saxony, 04229
GSK Investigational Site
Leipzig, Saxony, 04315
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39120
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116
GSK Investigational Site
Schmiedeberg, Saxony, 01762
GSK Investigational Site
Viersen, North Rhine-Westphalia, 41749
GSK Investigational Site
Winsen/Lohe, Lower Saxony, 21423
GSK Investigational Site
Wolmirstedt, Saxony-Anhalt, 39326
Netherlands9 sites
GSK Investigational Site
Almere Stad, 1311 RL
GSK Investigational Site
Deurne, 5751 XJ
GSK Investigational Site
Etten-Leur, 4872 LA
GSK Investigational Site
Nijverdal, 7442 LS
GSK Investigational Site
Rijswijk, 2281 AK
GSK Investigational Site
Roelofarendsveen, 2371 RB
GSK Investigational Site
Rotterdam, 3045 PM
GSK Investigational Site
Soerendonk, 6027 RN
GSK Investigational Site
The Hague, 2582 LJ
Norway9 sites
GSK Investigational Site
Bekkestua, N-1357
GSK Investigational Site
Fredrikstad, N-1601
GSK Investigational Site
Hamar, 2317
GSK Investigational Site
Oslo, 0160
GSK Investigational Site
Oslo, 0176
GSK Investigational Site
Oslo, 0319
GSK Investigational Site
Paradis, 5231
GSK Investigational Site
Soerumsand, N-1920
GSK Investigational Site
Stavanger, N-4011
France6 sites
GSK Investigational Site
Caen, 14052
GSK Investigational Site
Créteil, 94000
GSK Investigational Site
Gières, 38610
GSK Investigational Site
Lagord, 17140
GSK Investigational Site
Poitiers, 86000 cedex
GSK Investigational Site
Toulouse, 31300
Estonia3 sites
GSK Investigational Site
Tallinn, 10614
GSK Investigational Site
Tallinn, 11312
GSK Investigational Site
Tallinn, 13419
Lithuania3 sites
GSK Investigational Site
Kaunas, LT-50009
GSK Investigational Site
Vilnius, LT-08314
GSK Investigational Site
Vilnius, LT-08661
Belgium2 sites
GSK Investigational Site
Brussels, 1200
GSK Investigational Site
Liège, 4000
Finland2 sites
GSK Investigational Site
Kuopio, 70210
GSK Investigational Site
Tampere, 33200
About this study
Official title: A Multi-center, Three-staged With Interim Analyses, Parallel, Randomized, Double-blind, fenofibrate-and Placebo-controlled Proof of Concept and Dose-response Evaluation of the Safety, Tolerability, and Effects on Plasma High-density Lipoprotein Cholesterol (HDLc) and Triglycerides of Eight Weeks Treatment With GW501516 in Otherwise Healthy Patients With Low HDLc, Mildly to Moderately Elevated Triglycerides, and Normal Low-density Lipoprotein Cholesterol (LDLc)
The purpose of this clinical research study is to compare up to 3 doses of an investigational drug GW501516 to placebo (an inactive pill that looks like GW501516) to see if it is safe, well tolerated and effective in improving (raising) low levels of "good cholesterol", high-density lipoprotein cholesterol (HDLc), as compared to placebo.
Read the detailed description
A multicentre, two-staged with interim analysis, parallel, randomised, double blind, placebo-controlled, dose-ranging study of the safety, tolerability, and effects on plasma high-density lipoprotein cholesterol (HDLc) of 12 weeks treatment with 2.5mg, 5mg and 10mg daily doses of GW501516 in subjects with low HDLc
- Conditions
- Dyslipidaemias, Dyslipidaemia
- Being tested
- GW501516 oral tablets
- Keywords
- HDLc, high-density lipoprotein, Dyslipidemia
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW501516 oral tabletsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in fasting plasma HDLc concentration at the end of 12 weeks of double-blind treatment.
Measured: 12 Weeks
Secondary outcomes (1)
Changes from baseline at the end of 12 weeks of double-blind treatment of total cholesterol and other lipid parameters. Population pharmacokinetic parameters including oral clearance and apparent volume of distribution of GW501516.
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 posted12 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionJun 2006
- Study completionJun 2006
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
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, MA, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158899
- Sponsor's protocol ID
- PAD20001
- Status last verified
- May 2017
- First submitted
- 8 Sep 2005
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Three-staged With Interim Analyses, Parallel, Randomized, Double-blind, fenofibrate-and Placebo-controlled Proof of Concept and Dose-response Evaluation of the Safety, Tolerability, and Effects on Plasma High-density Lipoprotein Cholesterol (HDLc) and Triglycerides of Eight Weeks Treatment With GW501516 in Otherwise Healthy Patients With Low HDLc, Mildly to Moderately Elevated Triglycerides, and Normal Low-density Lipoprotein Cholesterol (LDLc)
- ClinicalTrials.gov ID
- NCT00158899
- Acronym / sponsor ID
- PAD20001
- Conditions
- Dyslipidaemias, Dyslipidaemia
- Keywords
- HDLc, high-density lipoprotein, Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 12 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.
The purpose of this clinical research study is to compare up to 3 doses of an investigational drug GW501516 to placebo (an inactive pill that looks like GW501516) to see if it is safe, well tolerated and effective in improving (raising) low levels of "good cholesterol", high-density lipoprotein cholesterol (HDLc), as compared to placebo.
Detailed description
A multicentre, two-staged with interim analysis, parallel, randomised, double blind, placebo-controlled, dose-ranging study of the safety, tolerability, and effects on plasma high-density lipoprotein cholesterol (HDLc) of 12 weeks treatment with 2.5mg, 5mg and 10mg daily doses of GW501516 in subjects with low HDLc
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a fasting plasma HDLc concentration <=45mg/dL (<=1.16mmol/L), plasma LDLc levels that do not require treatment according to the National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATPÂ III) guidelines.
- Have a fasting plasma TG concentration =500mg/dL (=5.65mmol/L).
Key exclusion criteria (3 listed)
- Coronary heart disease.
- Diabetes mellitus.
- Atherosclerotic disease.
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 |
|---|---|---|
| GW501516 oral tablets | Drug | – |
Primary outcome
The change from baseline in fasting plasma HDLc concentration at the end of 12 weeks of double-blind treatment.
Time frame: 12 Weeks
1 secondary outcome
Changes from baseline at the end of 12 weeks of double-blind treatment of total cholesterol and other lipid parameters. Population pharmacokinetic parameters including oral clearance and apparent volume of distribution of GW501516.
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 30 May 2017.
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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, MA study director
GlaxoSmithKline
64 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW501516 oral tablets in people with Dyslipidaemias and Dyslipidaemia, run by GlaxoSmithKline at 64 sites in 11 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 2 inclusion and 3 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in Germany, Netherlands, Norway, France, Estonia and 6 more countries. 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?
The change from baseline in fasting plasma HDLc concentration at the end of 12 weeks of double-blind treatment. (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 30 May 2017.