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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/NCT00841217




Registration number
NCT00841217
Ethics application status
Date submitted
10/02/2009
Date registered
11/02/2009
Date last updated
11/02/2009

Titles & IDs
Public title
Regulation of Lipoprotein Transport in Metabolic Syndrome
Scientific title
Effect of PPAR-Delta Agonist on Lipoprotein Kinetics in Metabolic Syndrome
Secondary ID [1] 0 0
UWA_PHR022009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Lipid Disorders 0 0
Cardiovascular Disease 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 - GW501516
Treatment: Drugs - placebo pill

Placebo Comparator: 1 - placebo group

Active Comparator: 2 - GW501516, 2.5mg


Treatment: Drugs: GW501516
2.5mg/day

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

Outcomes
Primary outcome [1] 0 0
ApoB transport rate
Timepoint [1] 0 0
5 weeks
Secondary outcome [1] 0 0
ApoA and C-III transport rate
Timepoint [1] 0 0
5 weeks

Eligibility
Key inclusion criteria
- Any three of the following:

- Waist circumference > 102 cm

- Triglycerides > 150 mg/dL

- HDL-cholesterol < 40 mg/dL

- Blood glucose > 110 mhg/dL

- Blood pressures > 130/85 mmHg
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Triglycerides > 500 mg/dL

- Diabetes mellitus

- CVD

- Consumption of > 30 g alcohol/day

- Use of agents affecting lipid metabolism

- APOE2/E2 genotype

- Creatinemia (> 120 umol/L)

- Hypothyroidism

- Abnormal liver and muscle enzymes

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?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 4
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
1/04/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
University of Western Australia - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Western Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Heart Foundation, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether PPAR-delta agonist (GW5015156)had favorable
effect on lipoprotein metabolism.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00841217
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT00841217