Effect of Sublingual (under the tongue) Rosuvastatin/Crestor (cholesterol/statin medication) in reducing the side effects experienced in subjects with high cholesterol & a history of cardiovascular disease (heart attack, coronary artery disease) with a known statin intolerance.
Clinical effects of Sublingually Administered Rosuvastatin in subjects who are Statin Intolerant - SARSI -001
Dr Gregory Szto
20 participants
Nov 4, 2016
Interventional
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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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 randomisation. Fasting blood tests will also be taken prior to each visit to monitor safety + progress of cholesterol levels
Locations(1)
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ACTRN12616001544460