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Study In Patients With Dyslipidaemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00264667
First received: December 9, 2005
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
Study in patients with dyslipidaemia.

Condition Intervention Phase
Metabolic Syndrome X Drug: GW677954 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percentage change from baseline in non-HDL-C based on log-transformed data at week 24.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 290
Study Start Date: December 2005
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • History of diabetes
  • History of cardiovascular disease
  • Diagnosis of genetic lipid disorders
  • History of muscle pain
  • History of cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264667

  Hide Study Locations
Locations
Argentina
GSK Investigational Site
Cordoba, Córdova, Argentina, 5000
GSK Investigational Site
Córdoba, Córdova, Argentina, 5000
GSK Investigational Site
Buenos Aires, Argentina, 1425
GSK Investigational Site
Buenos Aires, Argentina
GSK Investigational Site
Cordoba, Argentina, 5016
GSK Investigational Site
San Juan, Argentina, 5400
Australia, Queensland
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
GSK Investigational Site
Meadowbrook, Queensland, Australia, 4131
Australia, South Australia
GSK Investigational Site
Elizabeth Vale, South Australia, Australia, 5112
GSK Investigational Site
Keswick, South Australia, Australia, 5035
Australia, Victoria
GSK Investigational Site
Camperdown, Victoria, Australia, 2050
Chile
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7510605
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7571831
Costa Rica
GSK Investigational Site
San Jose, Costa Rica
India
GSK Investigational Site
Ahmedabad, India, 380 052
GSK Investigational Site
Bangalore, India, 560 054
GSK Investigational Site
Bangalore, India, 560034
GSK Investigational Site
Chennai, India, 600 116
GSK Investigational Site
Mumbai, India, 400008
Latvia
GSK Investigational Site
Riga, Latvia, LV 1002
GSK Investigational Site
Riga, Latvia, LV 1012
GSK Investigational Site
Riga, Latvia, LV1005
GSK Investigational Site
Riga, Latvia, LV1038
Mexico
GSK Investigational Site
Pachuca, Hidalgo, Mexico, 42039
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44340
GSK Investigational Site
Durango, Mexico, 34000
GSK Investigational Site
Mexico, D.F., Mexico, 11650
New Zealand
GSK Investigational Site
Auckland, New Zealand, 1311
GSK Investigational Site
Christchurch, New Zealand, 8014
GSK Investigational Site
Rotorua, New Zealand, 3201
Pakistan
GSK Investigational Site
Karachi, Pakistan, 74800
GSK Investigational Site
Lahore, Pakistan, 54000
Romania
GSK Investigational Site
Brasov, Romania, 500366
GSK Investigational Site
Bucharest, Romania, 020045
GSK Investigational Site
Deva, Romania, 330084
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 101990
GSK Investigational Site
Moscow, Russian Federation, 111020
GSK Investigational Site
Moscow, Russian Federation, 121 552
GSK Investigational Site
S.-Petresburg, Russian Federation, 195067
Slovakia
GSK Investigational Site
Kosice, Slovakia, 040 22
GSK Investigational Site
Kosice, Slovakia, 041 90
Spain
GSK Investigational Site
Alicante, Spain, 03114
GSK Investigational Site
Barcelona, Spain, 08022
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Granada, Spain, 18003
GSK Investigational Site
Granada, Spain, 18014
GSK Investigational Site
Madrid, Spain, 28037
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Móstoles/Madrid, Spain, 28935
GSK Investigational Site
Santiago de Compostela, Spain, 15706
GSK Investigational Site
Tarrasa, Barcelona, Spain, 08221
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: ADG103440
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: ADG103440
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: ADG103440
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: ADG103440
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: ADG103440
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: ADG103440
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: ADG103440
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00264667     History of Changes
Other Study ID Numbers: ADG103440
Study First Received: December 9, 2005
Last Updated: October 26, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Dyslipidaemia

Additional relevant MeSH terms:
Metabolic Syndrome X
Dyslipidemias
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on August 18, 2017