Efficacy and tolerability of Ezetimibe in cardiac transplant recipients taking Cyclospori
Phase 1
- Conditions
- Hyperlipidaemia in patients folowing cardiac transplantationMedDRA version: 14.0 Level: PT Classification code 10062060 Term: Hyperlipidaemia System Organ Class: 10027433 - Metabolism and nutrition disorders
- Registration Number
- EUCTR2006-005565-18-GB
- Lead Sponsor
- Research and Development Department, University Hospital of South Manchester NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 76
Inclusion Criteria
Heart transplant recipients at least 3 months post transplant and currently taking cyclosporin, will be included whether they are taking statin therapy or not, regardless of their fasting lipid profile.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Exclusion criteria are:
1. Derangement of liver function tests or creatinine kinase (CK) levels (defined as AST/ALT or CK > 2 x upper limit of normal)
2. Concurrent malignancy
3. Lack of informed consent
4. Previous intolerance or allergy to Ezetimibe
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method