RecruitingPhase 2Phase 3ACTRN12616001544460

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


Sponsor

Dr Gregory Szto

Enrollment

20 participants

Start Date

Nov 4, 2016

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking a cholesterol-lowering statin (rosuvastatin) under the tongue — instead of swallowing it — reduces the muscle aches, memory problems, and other side effects that caused the person to stop taking statins in the first place. People who need statins for heart disease but can't tolerate them may benefit from this alternative way of taking the medication. You may be eligible if: - You are 18 years of age or older - You have had side effects from statins such as muscle pain or memory changes - You stopped taking statins more than 1 month ago - You have a history of heart disease or coronary artery disease - Your total cholesterol is above 5.5 mmol/L and has not reached the target level You may NOT be eligible if: - You have uncontrolled diabetes (HbA1c above 9%) - You have abnormal liver enzymes or elevated creatine kinase - You have significant kidney impairment - You have a history of drug or alcohol dependency - You are a woman using hormonal therapy or oral contraceptives - You are pregnant or breastfeeding Talk to your doctor about whether this trial might be right for you.

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 ano

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)

VIC, Australia

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ACTRN12616001544460


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