Status:
COMPLETED
Study of Heart and Renal Protection
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Schering-Plough
Conditions:
Kidney Disease, Chronic
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
The chief aim of SHARP was to determine whether lowering blood LDL cholesterol with simvastatin (20mg) plus ezetimibe (10mg) daily could safely reduce the risk of coronary heart disease, non-hemorrhag...
Detailed Description
The SHARP (Study of Heart and Renal Protection) was a double-blind placebo-controlled trial which aimed to assess the safety and efficacy of reducing LDL cholesterol in more than 9,000 patients with c...
Eligibility Criteria
Inclusion
- History of chronic kidney disease (CKD): either patients who are pre-dialysis (with a plasma or serum creatinine greater than or equal to 150 micromol/l \[greater than or equal to 1.7 mg/dl\] in men, or greater than or equal to 130 micromol/l \[greater than or equal to 1.5 mg/dl\] in women); or patients on dialysis (hemodialysis or peritoneal dialysis)
- Men or women aged greater than or equal to 40 years
Exclusion
- Definite history of myocardial infarction or coronary revascularization procedure
- Functioning renal transplant, or living donor-related transplant planned
- Less than 2 months since presentation as an acute uraemic emergency (but could be entered later, if appropriate)
- Definite history of chronic liver disease, or abnormal liver function (i.e. alanine aminotransferase \[ALT\] greater than 1.5 x upper limit of normal \[ULN\] or, if ALT not available, aspartate aminotransferase \[AST\] greater than 1.5 x ULN). (Note: Patients with a history of hepatitis were eligible provided these limits were not exceeded.)
- Evidence of active inflammatory muscle disease (e.g. dermatomyositis, polymyositis), or creatine kinase (CK) greater than 3 x ULN
- Definite previous adverse reaction to a statin or to ezetimibe
- Concurrent treatment with a contraindicated drug. (Note: Patients who were temporarily taking such drugs could have been re-screened for participation in the study when they discontinued them, if appropriate.) These contraindicated drugs included: HMG-CoA reductase inhibitor ("statin"); fibric acid derivative ("fibrate"); nicotinic acid; macrolide antibiotic (erythromycin, clarithromycin); systemic use of imidazole or triazole antifungals (e.g. itraconazole, ketoconazole); protease-inhibitors (e.g. antiretroviral drugs for HIV infection); nefazodone; ciclosporin
- Child-bearing potential (i.e. premenopausal woman who was not using a reliable method of contraception)
- Known to be poorly compliant with clinic visits or prescribed medication
- Medical history that might have limited the individual's ability to take trial treatments for the duration of the study (e.g. severe respiratory disease, history of cancer other than non-melanoma skin cancer, or recent history of alcohol or substance misuse)
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
9438 Patients enrolled
Trial Details
Trial ID
NCT00125593
Start Date
June 1 2003
End Date
August 1 2010
Last Update
February 1 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Trial Service Unit & Epidemiological Studies Unit, University of Oxford
Oxford, United Kingdom, OX3 7LF