Metabolic Syndrome XPhase 2NCT00264667
Study In Patients With Dyslipidaemia
A Phase 2 study testing GW677954 in people with Metabolic Syndrome X, run by GlaxoSmithKline at 50 sites in 13 countries.
Trial summary
Study in patients with dyslipidaemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- GW677954
- How many people
- 290 participants
- Where
- 50 sitesin 13 countries
- Study dates
- Dec 2005to Jun 2007
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Waist circumference =102cm (men) or =88cm (women) at visit 1.
- Fasting plasma HDL C =40mg/dL (1.03mmol/L) (men) or =50mg/dL (1.29mmol/L) (women) at Screening Visit 1.
- Fasting TGs =150mg/dL (1.69mmol/L) and =800mg/dL (8.96mmol/L) at Screening Visit 1.
- Subjects whose plasma LDL C concentration does not require treatment according to the NCEP ATP III guidelines at Screening Visit 1.
Who cannot join
- History of diabetes
- History of cardiovascular disease
- Diagnosis of genetic lipid disorders
- History of muscle pain
- History of cancer
Trial locations and contacts
50 sites in 13 countries.
50 sites in 13 countries
Spain10 sites
GSK Investigational Site
Alicante, 03114
GSK Investigational Site
Barcelona, 08022
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Granada, 18003
GSK Investigational Site
Granada, 18014
GSK Investigational Site
Madrid, 28037
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Móstoles/Madrid, 28935
GSK Investigational Site
Santiago de Compostela, 15706
GSK Investigational Site
Tarrasa, Barcelona, 08221
Argentina5 sites
GSK Investigational Site
Buenos Aires, Buenos Aires, 1425
GSK Investigational Site
Buenos Aires
GSK Investigational Site
Córdoba, Córdoba Province, 5000
GSK Investigational Site
Córdoba, 5016
GSK Investigational Site
San Juan, 5400
Australia5 sites
GSK Investigational Site
Camperdown, Victoria, 2050
GSK Investigational Site
Elizabeth Vale, South Australia, 5112
GSK Investigational Site
Keswick, South Australia, 5035
GSK Investigational Site
Kippa-Ring, Queensland, 4021
GSK Investigational Site
Meadowbrook, Queensland, 4131
India5 sites
GSK Investigational Site
Ahmedabad, 380 052
GSK Investigational Site
Bangalore, 560 054
GSK Investigational Site
Bangalore, 560034
GSK Investigational Site
Chennai, 600 116
GSK Investigational Site
Mumbai, 400008
Latvia4 sites
GSK Investigational Site
Riga, LV 1002
GSK Investigational Site
Riga, LV 1012
GSK Investigational Site
Riga, LV1005
GSK Investigational Site
Riga, LV1038
Mexico4 sites
GSK Investigational Site
Durango, Durango, 34000
GSK Investigational Site
Guadalajara, Jalisco, 44340
GSK Investigational Site
Mexico City, 11650
GSK Investigational Site
Pachuca, Hidalgo, 42039
Russia4 sites
GSK Investigational Site
Moscow, 101990
GSK Investigational Site
Moscow, 111020
GSK Investigational Site
Moscow, 121 552
GSK Investigational Site
S.-Petresburg, 195067
New Zealand3 sites
GSK Investigational Site
Auckland, 1311
GSK Investigational Site
Christchurch, 8014
GSK Investigational Site
Rotorua, 3201
Romania3 sites
GSK Investigational Site
Brasov, 500366
GSK Investigational Site
Bucharest, 020045
GSK Investigational Site
Deva, 330084
Chile2 sites
GSK Investigational Site
Santiago, Región Metro de Santiago, 7510605
GSK Investigational Site
Santiago, Región Metro de Santiago, 7571831
Pakistan2 sites
GSK Investigational Site
Karachi, 74800
GSK Investigational Site
Lahore, 54000
Slovakia2 sites
GSK Investigational Site
Košice, 040 22
GSK Investigational Site
Košice, 041 90
About this study
Official title: A Randomised,Double-blind, Parallel Group, Placebo-controlled, Multicentre Study to Evaluate the Safety, Tolerability and Efficacy of Oral GW677954 Capsules 2.5mg, 5mg, 10mg and 20mg a Day for 24 Weeks in Overweight Dyslipidaemic Subjects
Study in patients with dyslipidaemia.
- Conditions
- Metabolic Syndrome X
- Being tested
- GW677954
- Keywords
- Dyslipidaemia
- Medical subject headings
- Metabolic Syndrome, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW677954Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in non-HDL-C based on log-transformed data at week 24.
Secondary outcomes (1)
Percentage change from baseline in lipids, in Homeostasis Model Assessment-insulin sensitivity (HOMA-S), C-Reactive Protein (CRP), Fasting Plasma Glucose (FPG), body weight and waist circumference.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study startDec 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies 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
- 290 participants
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
- NCT00264667
- Sponsor's protocol ID
- ADG103440
- Status last verified
- Oct 2016
- First submitted
- 9 Dec 2005
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised,Double-blind, Parallel Group, Placebo-controlled, Multicentre Study to Evaluate the Safety, Tolerability and Efficacy of Oral GW677954 Capsules 2.5mg, 5mg, 10mg and 20mg a Day for 24 Weeks in Overweight Dyslipidaemic Subjects
- ClinicalTrials.gov ID
- NCT00264667
- Acronym / sponsor ID
- ADG103440
- Conditions
- Metabolic Syndrome X
- Keywords
- Dyslipidaemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 13 Dec 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.
Study in patients with dyslipidaemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Waist circumference =102cm (men) or =88cm (women) at visit 1.
- Fasting plasma HDL C =40mg/dL (1.03mmol/L) (men) or =50mg/dL (1.29mmol/L) (women) at Screening Visit 1.
- Fasting TGs =150mg/dL (1.69mmol/L) and =800mg/dL (8.96mmol/L) at Screening Visit 1.
- Subjects whose plasma LDL C concentration does not require treatment according to the NCEP ATP III guidelines at Screening Visit 1.
Key exclusion criteria (5 listed)
- History of diabetes
- History of cardiovascular disease
- Diagnosis of genetic lipid disorders
- History of muscle pain
- History of cancer
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 |
|---|---|---|
| GW677954 | Drug | – |
Primary outcome
Percentage change from baseline in non-HDL-C based on log-transformed data at week 24.
1 secondary outcome
Percentage change from baseline in lipids, in Homeostasis Model Assessment-insulin sensitivity (HOMA-S), C-Reactive Protein (CRP), Fasting Plasma Glucose (FPG), body weight and waist circumference.
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 28 Oct 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Related trials for Metabolic Syndrome X
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Recruiting
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Recruiting
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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 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW677954 in people with Metabolic Syndrome X, run by GlaxoSmithKline at 50 sites in 13 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 4 inclusion and 5 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 28 Oct 2016. 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 Spain, Argentina, Australia, India, Latvia and 8 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?
Percentage change from baseline in non-HDL-C based on log-transformed data at week 24.. 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 28 Oct 2016.