Improving Tolerability of Statins - ITS-SGH
- Conditions
- Subjects for whom statin intake is a necessary therapeutic intervention i.e diabetics, dyslipidemics and patients with ischaemic heart disease.
- Registration Number
- EUCTR2006-001198-18-IE
- Lead Sponsor
- Sligo General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
a. Individuals for whom intake of statin (ATORVASTATIN) is necessary as therapeutic intervention
b. Age 18 – 80 years old
c. Previous history of muscular related adverse reactions excluding rhabdomyolysis
d. Females: Post-menopausal, otherwise female using effective barrier contraception or is surgically sterilised
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
a. Previous history of rhabdomyolysis/angioedema associated with statin therapy
b. Hepatic and renal failure
c. Females who are pregnant or are planning pregnancy or are breastfeeding
d. Alcohol abuse
e. Patients who are enrolled in another clinical trial or who have been enrolled in a clinical trial in the 12 weeks preceding the study
f. Patients on acid lowering drugs (H2 antagonistis/proton pump inhibitor) or an antacids
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