NCT00841217

CompletedPhase 4

Regulation of Lipoprotein Transport in Metabolic Syndrome

The University of Western Australia Source

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Other study identifiers

Sponsor study identifier

UWA_PHR022009

Study Type

interventional

Actual enrollment (reported)

13

Locations

1 country

Sites

1

Timeline

Study Start

April 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2005

Actual (reported)

Study Completion

December 2008

Actual (reported)

Brief Summary

The purpose of this study is to determine whether PPAR-delta agonist (GW5015156)had favorable effect on lipoprotein metabolism.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 13 participants
Study completion date: December 2008
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2003
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
August 2005
Actual (reported)
Study Completion
December 2008
Actual (reported)
First Submitted
February 10, 2009
Actual (reported)
First Posted
February 11, 2009
Actual (reported)

Last Updated: February 11, 2009
Status Verified: February 2009
Last Update Submitted: February 10, 2009

Conditions

Cardiovascular Disease Lipid Disorders Obesity

Keywords

Drug treatment

Outcome Measures

Primary Outcomes (1)

ApoB transport rate
5 weeks

Secondary Outcomes (1)

ApoA and C-III transport rate
5 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

placebo group

Drug: placebo pill

2

ACTIVE COMPARATOR

GW501516, 2.5mg

Drug: GW501516

Interventions

GW501516Drug

2.5mg/day

2

placebo pillDrug

1

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Any three of the following:
Waist circumference \> 102 cm

Sponsors & Collaborators

National Heart Foundation, Australia
Othercollaborator
The University of Western Australia
Otherlead

Study Sites (1)

University of Western Australia

Perth, Western Australia, 6000, Australia

Related Publications (1)

Ooi EM, Watts GF, Sprecher DL, Chan DC, Barrett PH. Mechanism of action of a peroxisome proliferator-activated receptor (PPAR)-delta agonist on lipoprotein metabolism in dyslipidemic subjects with central obesity. J Clin Endocrinol Metab. 2011 Oct;96(10):E1568-76. doi: 10.1210/jc.2011-1131. Epub 2011 Aug 3.
PMID: 21816786DERIVED

MeSH Terms

Conditions

ObesityLipid Metabolism DisordersCardiovascular Diseases

Interventions

GW 501516

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMetabolic Diseases

Enrollment

13 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

April 2003

Date type not reported

This date has not been verified as actual or estimated.

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Triglycerides \> 150 mg/dL

HDL-cholesterol \< 40 mg/dL

Blood glucose \> 110 mhg/dL

Blood pressures \> 130/85 mmHg

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

August 2005

Actual (reported)

Study Completion

December 2008

Actual (reported)

Last Updated

February 11, 2009

Record last verified: 2009-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00841217
Data provider: ClinicalTrials.gov
Source updated: 2009-02-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:53 UTC

Locations

AU(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations