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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00841217




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

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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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
Other publications