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Study In Patients With Dyslipidaemia

Primary Purpose

Metabolic Syndrome X

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GW677954
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome X focused on measuring Dyslipidaemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

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.

Full Information

First Posted
December 9, 2005
Last Updated
October 26, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00264667
Brief Title
Study In Patients With Dyslipidaemia
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 Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Study in patients with dyslipidaemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
Keywords
Dyslipidaemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
290 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW677954
Primary Outcome Measure Information:
Title
Percentage change from baseline in non-HDL-C based on log-transformed data at week 24.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Cordoba
State/Province
Córdova
ZIP/Postal Code
5000
Country
Argentina
Facility Name
GSK Investigational Site
City
Córdoba
State/Province
Córdova
ZIP/Postal Code
5000
Country
Argentina
Facility Name
GSK Investigational Site
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
GSK Investigational Site
City
Buenos Aires
Country
Argentina
Facility Name
GSK Investigational Site
City
Cordoba
ZIP/Postal Code
5016
Country
Argentina
Facility Name
GSK Investigational Site
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Facility Name
GSK Investigational Site
City
Kippa Ring
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
Facility Name
GSK Investigational Site
City
Meadowbrook
State/Province
Queensland
ZIP/Postal Code
4131
Country
Australia
Facility Name
GSK Investigational Site
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
GSK Investigational Site
City
Keswick
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
GSK Investigational Site
City
Camperdown
State/Province
Victoria
ZIP/Postal Code
2050
Country
Australia
Facility Name
GSK Investigational Site
City
Santiago
State/Province
Región Metro De Santiago
ZIP/Postal Code
7510605
Country
Chile
Facility Name
GSK Investigational Site
City
Santiago
State/Province
Región Metro De Santiago
ZIP/Postal Code
7571831
Country
Chile
Facility Name
GSK Investigational Site
City
San Jose
Country
Costa Rica
Facility Name
GSK Investigational Site
City
Ahmedabad
ZIP/Postal Code
380 052
Country
India
Facility Name
GSK Investigational Site
City
Bangalore
ZIP/Postal Code
560 054
Country
India
Facility Name
GSK Investigational Site
City
Bangalore
ZIP/Postal Code
560034
Country
India
Facility Name
GSK Investigational Site
City
Chennai
ZIP/Postal Code
600 116
Country
India
Facility Name
GSK Investigational Site
City
Mumbai
ZIP/Postal Code
400008
Country
India
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV 1002
Country
Latvia
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV 1012
Country
Latvia
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV1005
Country
Latvia
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV1038
Country
Latvia
Facility Name
GSK Investigational Site
City
Pachuca
State/Province
Hidalgo
ZIP/Postal Code
42039
Country
Mexico
Facility Name
GSK Investigational Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Facility Name
GSK Investigational Site
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
GSK Investigational Site
City
Mexico, D.F.
ZIP/Postal Code
11650
Country
Mexico
Facility Name
GSK Investigational Site
City
Auckland
ZIP/Postal Code
1311
Country
New Zealand
Facility Name
GSK Investigational Site
City
Christchurch
ZIP/Postal Code
8014
Country
New Zealand
Facility Name
GSK Investigational Site
City
Rotorua
ZIP/Postal Code
3201
Country
New Zealand
Facility Name
GSK Investigational Site
City
Karachi
ZIP/Postal Code
74800
Country
Pakistan
Facility Name
GSK Investigational Site
City
Lahore
ZIP/Postal Code
54000
Country
Pakistan
Facility Name
GSK Investigational Site
City
Brasov
ZIP/Postal Code
500366
Country
Romania
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
020045
Country
Romania
Facility Name
GSK Investigational Site
City
Deva
ZIP/Postal Code
330084
Country
Romania
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
101990
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
111020
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
121 552
Country
Russian Federation
Facility Name
GSK Investigational Site
City
S.-Petresburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Kosice
ZIP/Postal Code
040 22
Country
Slovakia
Facility Name
GSK Investigational Site
City
Kosice
ZIP/Postal Code
041 90
Country
Slovakia
Facility Name
GSK Investigational Site
City
Alicante
ZIP/Postal Code
03114
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
GSK Investigational Site
City
Granada
ZIP/Postal Code
18003
Country
Spain
Facility Name
GSK Investigational Site
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28037
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
GSK Investigational Site
City
Móstoles/Madrid
ZIP/Postal Code
28935
Country
Spain
Facility Name
GSK Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
GSK Investigational Site
City
Tarrasa, Barcelona
ZIP/Postal Code
08221
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
ADG103440
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
ADG103440
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
ADG103440
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
ADG103440
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
ADG103440
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
ADG103440
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
ADG103440
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Study In Patients With Dyslipidaemia

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