None listed
Conditions
Brief summary
The purpose of the study is to determine if the daily administration of sublingual (under the tongue) Rosuvastatin (cholesterol drug) is effective in reducing cholesterol level and the side effects of muscle aches and or memory changes in subjects with coronary artery disease & cardiovascular risk factors who are not yet at optimal cholesterol levels.
Interventions
The trial involves the sublingual administration of 5mg Rosuvastatin and placebo on a daily nocturnal basis in the subjects home. The trial drug is administered for 6 weeks with 2 week washout and another 6 weeks of matching placebo (or visa versa depending on randomisation schedule. Demonstration using sublingual placebo administration will occur at randomisation visit and subject compliance will be assessed at each visit by way of counting the number of tablets returned : number of days since
The trial involves the sublingual administration of 5mg Rosuvastatin and placebo on a daily nocturnal basis in the subjects home. The trial drug is administered for 6 weeks with 2 week washout and another 6 weeks of matching placebo (or visa versa depending on randomisation schedule. Demonstration using sublingual placebo administration will occur at randomisation visit and subject compliance will be assessed at each visit by way of counting the number of tablets returned : number of days since randomisation. Fasting blood tests will also be taken prior to each visit to monitor safety + progress of cholesterol levels
Sponsors
Dr Gregory Szto
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Has suffered side effects attributable to the statin including myalgia, abnormal liver function tests, and/or memory problems. Has stopped taking statins more than 1 month prior to enrolment Has existing total cholesterol of > 5.5 mmol/L Has a history of cardiovascular ischaemic heart disease and is not yet at target levels TC< 4.0mmol/L
Exclusion criteria
1. Has uncontrolled diabetes, defined by a HbA1c > 9% as measured at visit 1 2. Has alanine aminotransferase (ALT) > 1.5 times ULN as measured at visit 1 3. Has aspartate aminotransferase (AST) > 1.5 times ULN as measured at visit 1 4. Has creatine kinase (CK) > 1.5 times ULN as measured at visit 1 5. Has triglycerides (TG) > 4.5 mmol/L as measured at visit 1 6. Has evidence of renal impairment with a serum creatinine of > 200 µmol/L as measured at visit 1 7. Has known drug or alcohol dependency within 6 months of visit 1 8. A woman receiving hormonal therapy, including hormone replacement, any oestrogen agonist/antagonist, or oral contraceptives 9. A woman of childbearing potential not using a an acceptable method of birth control (e.g. hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) 10. Woman who is pregnant or breast feeding 11. Any condition or situation which, in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study.
Outcome results
None listed