EUCTR2005-001558-26-ES
Active, not recruiting
Phase 1
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 WEEKS IN OVERWEIGHT DYSLIPIDAEMIC SUBJECTS
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Dyslipidaemia and overweight
- Sponsor
- GlaxoSmithKline, S.A.
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Waist circumference \=102cm (men) or \=88cm (women) at visit 1
- •2\. Fasting plasma HDL\-C \=40mg/dL (1\.03mmol/L) (men) or \=50mg/dL (1\.29mmol/L)
- •(women) at Screening Visit 1
- •3\. Fasting TGs \=150mg/dL (1\.69mmol/L) and \=800mg/dL (8\.96mmol/L) at Screening
- •4\. Subjects whose plasma LDL\-C concentration does not require treatment according to the NCEP ATP III guidelines at Screening Visit 1
- •Plasma LDL\-C concentration \=190mg/dL (\=4\.91mmol/L) if no more than one
- •cardiovascular risk factor, or
- •Plasma LDL\-C concentration \=160mg/dL (\=4\.13mmol/L) if two or more
- •cardiovascular risk factors, and a 10\-year congestive heart failure (CHF) risk
- •\=10% (Framingham Point Scores), or
Exclusion Criteria
- •1\. Metabolic Disease including:
- •Diagnosis of Type 1 or Type 2 diabetes mellitus, or FPG at Screening, and at Visit 2 both \>126mg/dL (\>7\.0mmol/L);
- •Uncorrected thyroid dysfunction;
- •Significant weight gain or loss within the 3 months prior to Screening (Visit 1\).
- •2\. History of recent clinically significant cardiovascular disease at Visit 2 including:
- •History or ECG evidence of prior myocardial infarction
- •Current unstable angina or history of unstable angina
- •Coronary revascularization including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery that is either planned or occurred in the 6 months prior to Screening.
- •Clinically significant arrhythmia or valvular heart disease.
- •Congestive heart failure with NYHA Class II\-IV symptoms.
Outcomes
Primary Outcomes
Not specified
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