Study In Patients With Dyslipidaemia
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
1 other identifier
interventional
290
13 countries
50
Brief Summary
Study in patients with dyslipidaemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2005
Shorter than P25 for phase_2
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 9, 2005
CompletedFirst Posted
Study publicly available on registry
December 13, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedOctober 28, 2016
October 1, 2016
December 9, 2005
October 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of diabetes
- History of cardiovascular disease
- Diagnosis of genetic lipid disorders
- History of muscle pain
- History of cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (50)
GSK Investigational Site
Buenos Aires, Buenos Aires, 1425, Argentina
GSK Investigational Site
Córdoba, Córdoba Province, 5000, Argentina
GSK Investigational Site
Buenos Aires, Argentina
GSK Investigational Site
Córdoba, 5016, Argentina
GSK Investigational Site
San Juan, 5400, Argentina
GSK Investigational Site
Kippa-Ring, Queensland, 4021, Australia
GSK Investigational Site
Meadowbrook, Queensland, 4131, Australia
GSK Investigational Site
Elizabeth Vale, South Australia, 5112, Australia
GSK Investigational Site
Keswick, South Australia, 5035, Australia
GSK Investigational Site
Camperdown, Victoria, 2050, Australia
GSK Investigational Site
Santiago, Región Metro de Santiago, 7510605, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7571831, Chile
GSK Investigational Site
San José, Costa Rica
GSK Investigational Site
Ahmedabad, 380 052, India
GSK Investigational Site
Bangalore, 560 054, India
GSK Investigational Site
Bangalore, 560034, India
GSK Investigational Site
Chennai, 600 116, India
GSK Investigational Site
Mumbai, 400008, India
GSK Investigational Site
Riga, LV 1002, Latvia
GSK Investigational Site
Riga, LV 1012, Latvia
GSK Investigational Site
Riga, LV1005, Latvia
GSK Investigational Site
Riga, LV1038, Latvia
GSK Investigational Site
Durango, Durango, 34000, Mexico
GSK Investigational Site
Pachuca, Hidalgo, 42039, Mexico
GSK Investigational Site
Guadalajara, Jalisco, 44340, Mexico
GSK Investigational Site
Mexico City, 11650, Mexico
GSK Investigational Site
Auckland, 1311, New Zealand
GSK Investigational Site
Christchurch, 8014, New Zealand
GSK Investigational Site
Rotorua, 3201, New Zealand
GSK Investigational Site
Karachi, 74800, Pakistan
GSK Investigational Site
Lahore, 54000, Pakistan
GSK Investigational Site
Brasov, 500366, Romania
GSK Investigational Site
Bucharest, 020045, Romania
GSK Investigational Site
Deva, 330084, Romania
GSK Investigational Site
Moscow, 101990, Russia
GSK Investigational Site
Moscow, 111020, Russia
GSK Investigational Site
Moscow, 121 552, Russia
GSK Investigational Site
S.-Petresburg, 195067, Russia
GSK Investigational Site
Košice, 040 22, Slovakia
GSK Investigational Site
Košice, 041 90, Slovakia
GSK Investigational Site
Alicante, 03114, Spain
GSK Investigational Site
Barcelona, 08022, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Granada, 18003, Spain
GSK Investigational Site
Granada, 18014, Spain
GSK Investigational Site
Madrid, 28037, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Móstoles/Madrid, 28935, Spain
GSK Investigational Site
Santiago de Compostela, 15706, Spain
GSK Investigational Site
Tarrasa, Barcelona, 08221, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2005
First Posted
December 13, 2005
Study Start
December 1, 2005
Study Completion
June 1, 2007
Last Updated
October 28, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.