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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00264667




Registration number
NCT00264667
Ethics application status
Date submitted
9/12/2005
Date registered
13/12/2005
Date last updated
28/10/2016

Titles & IDs
Public title
Study In Patients With Dyslipidaemia
Scientific 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
Secondary ID [1] 0 0
ADG103440
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome X 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GW677954

Treatment: Drugs: GW677954
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage change from baseline in non-HDL-C based on log-transformed data at week 24.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of diabetes

- History of cardiovascular disease

- Diagnosis of genetic lipid disorders

- History of muscle pain

- History of cancer

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [2] 0 0
GSK Investigational Site - Meadowbrook
Recruitment hospital [3] 0 0
GSK Investigational Site - Elizabeth Vale
Recruitment hospital [4] 0 0
GSK Investigational Site - Keswick
Recruitment hospital [5] 0 0
GSK Investigational Site - Camperdown
Recruitment postcode(s) [1] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [2] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
5035 - Keswick
Recruitment postcode(s) [5] 0 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Córdova
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Cordoba
Country [4] 0 0
Argentina
State/province [4] 0 0
San Juan
Country [5] 0 0
Chile
State/province [5] 0 0
Región Metro De Santiago
Country [6] 0 0
Costa Rica
State/province [6] 0 0
San Jose
Country [7] 0 0
India
State/province [7] 0 0
Ahmedabad
Country [8] 0 0
India
State/province [8] 0 0
Bangalore
Country [9] 0 0
India
State/province [9] 0 0
Chennai
Country [10] 0 0
India
State/province [10] 0 0
Mumbai
Country [11] 0 0
Latvia
State/province [11] 0 0
Riga
Country [12] 0 0
Mexico
State/province [12] 0 0
Hidalgo
Country [13] 0 0
Mexico
State/province [13] 0 0
Jalisco
Country [14] 0 0
Mexico
State/province [14] 0 0
Durango
Country [15] 0 0
Mexico
State/province [15] 0 0
Mexico, D.F.
Country [16] 0 0
New Zealand
State/province [16] 0 0
Auckland
Country [17] 0 0
New Zealand
State/province [17] 0 0
Christchurch
Country [18] 0 0
New Zealand
State/province [18] 0 0
Rotorua
Country [19] 0 0
Pakistan
State/province [19] 0 0
Karachi
Country [20] 0 0
Pakistan
State/province [20] 0 0
Lahore
Country [21] 0 0
Romania
State/province [21] 0 0
Brasov
Country [22] 0 0
Romania
State/province [22] 0 0
Bucharest
Country [23] 0 0
Romania
State/province [23] 0 0
Deva
Country [24] 0 0
Russian Federation
State/province [24] 0 0
Moscow
Country [25] 0 0
Russian Federation
State/province [25] 0 0
S.-Petresburg
Country [26] 0 0
Slovakia
State/province [26] 0 0
Kosice
Country [27] 0 0
Spain
State/province [27] 0 0
Alicante
Country [28] 0 0
Spain
State/province [28] 0 0
Barcelona
Country [29] 0 0
Spain
State/province [29] 0 0
Granada
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid
Country [31] 0 0
Spain
State/province [31] 0 0
Móstoles/Madrid
Country [32] 0 0
Spain
State/province [32] 0 0
Santiago de Compostela
Country [33] 0 0
Spain
State/province [33] 0 0
Tarrasa, Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Study in patients with dyslipidaemia.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00264667
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00264667