Study To Evaluate The Effects Of GW856553 On Endothelial Function/Vascular Compliance In Subjects… (NCT00474864) | Clinical Trial Compass
CompletedPhase 2
Study To Evaluate The Effects Of GW856553 On Endothelial Function/Vascular Compliance In Subjects With Dyslipidaemia.
United Kingdom66 participantsStarted 2007-07
Plain-language summary
The rationale for this study is to determine whether GW856553 (7.5mg BD for 28 days) has an effect on endothelial function in dyslipidaemic subjects as assessed by venous occlusion plethysmography using brachial artery acetylcholine infusion. This will establish consistency with preclinical findings, as well as confirm a physiologic human response at the current safe maximal dose. Safety (specifically serum liver function testing) and tolerability will also be evaluated in this trial.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy adult male and females between 18 and 75 years of age, inclusive.
* To be eligible, female subjects must have a negative pregnancy test (i.e. Urine or serum β-hCG (for females) and be of:
* non-childbearing potential (i.e. physiologically incapable of becoming pregnant). This includes any female who is post-menopausal.
OR
* childbearing potential and agree to commit to one of the protocol-approved methods of contraception.
* Body weight \> 50 kg and body mass index (BMI) between 19 and 32kg/m2
* Subjects with high LDLc levels, as per NCEP ATPIII criteria:fasting LDLc level \> 4.1 mmol/L (160 mg/dL), inclusive. Fasting TG level should be \< 4.5mmol/L (400 mg/dL)
* A signed and dated written informed consent prior to admission to the study
* The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
The following criteria must apply only for subjects undergoing FDG-PET/CT and MRI
* All diabetics will be excluded from the scanning sub-study involving MRI and FDGPET/CT.
* Subjects will be excluded who have previously participated in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden (a significant radiation burden being defined as ICRP category IIb or above: No more than 10 mSv effective radiation dose in addition to natural background radiation, in the previous 3 years including the dose from …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Forearm blood flow ratio measured at baseline and day 28.