EUCTR2006-002911-28-CZ
Active, not recruiting
Not Applicable
A multicentre, randomized, double-blind, parallel-group, placebo-controlled, dose-ranging study to evaluate the efficacy, safety and tolerability of once daily oral dosing of GW501516 (2.5 mg, 5 mg and 10 mg) over 12 weeks in subjects withprimary hypercholesterolemia on background statin therapy.
GlaxoSmithKline R&D0 sites192 target enrollmentSeptember 25, 2006
Conditionsprimary hypercholesterolemiaMedDRA version: 8.1Level: LLTClassification code 10020604Term: Hypercholesterolemia
DrugsN/A
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- primary hypercholesterolemia
- Sponsor
- GlaxoSmithKline R&D
- Enrollment
- 192
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female subjects aged 18\-70 years (inclusive at the time of Pre\- Screening
- •2\. Subjects who are on stable, approved dose of Simvastatin (20, 40 or 80 mg) or
- •Atorvastatin (10, 20, 40 or 80 mg) for a minimum of 8 Weeks prior to the prescreening visit 1\.
- •3\. Subjects with stable LDL\-C \=100 mg/dl (2\.59 mmol/L) and \=160 mg/dL (4\.14
- •mmol/L) at Visits 1 and 2
- •4\. Females, to be eligible to enter and participate in this study must be:
- •of non –child bearing potential ( i.e. physiologically incapable of becoming
- •pregnant (tubal ligation, documented hysterectomy), including any female who
- •is post\-menopausal \[\> 1 year without menstrual period and FSH/estradiol
- •concentrations are consistent with postmenopausal state]. Other reasons for
Exclusion Criteria
- •1\. Metabolic Disease including:
- •Diagnosis of Type 1 or Type 2 diabetes mellitus, or FPG \>126mg/dL(\>7\.0mmol/L)
- •Uncorrected thyroid dysfunction
- •Significant weight gain or loss within the past 3 months prior to Screening Visit 2\.
- •2\. History of recent clinically significant cardiovascular disease at Visit 2 including:
- •CHD, CHF (NYHA Class II\-IV), stroke, peripheral vascular disease.
- •History or ECG evidence of prior myocardial infarction in the past 6 months.
- •Current unstable angina or history of unstable angina in the past 6 months.
- •Coronary revascularization including percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery
- •Clinically significant arrhythmia or valve heart disease.
Outcomes
Primary Outcomes
Not specified
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