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Statins
Rosuvastatin for Statin Adverse Reaction Syndrome
Minneapolis, MN
Phase 4
Recruiting
Research Sponsored by Minneapolis Heart Institute Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Women who are pregnant, nursing or attempting to become pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial tested whether patients who had trouble tolerating a type of medication called statins could tolerate a specific type of statin, rosuvastatin, when they knew they were taking it.
See full description
Who is the study for?
The DESIFOR-EXPAND trial is for adults over 21 who've had to stop taking at least two different statins due to side effects. They can still be on other cholesterol-lowering meds if they've been stable on them for a month. It's not for those with severe past reactions, women who are pregnant or nursing, or anyone not suited for rosuvastatin.Check my eligibility
What is being tested?
This study tests whether patients with previous statin intolerance can tolerate an unblinded dose of Rosuvastatin (Crestor) compared to a placebo. The goal is to see if the n-of-1 trial design helps in managing and understanding individual responses to the drug.See study design
What are the potential side effects?
Possible side effects include muscle pain, weakness, digestive issues, and increased blood sugar levels which are common complaints among those previously intolerant to statins. Severe side effects like rhabdomyolysis are rare but have led to exclusion from this trial.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, nursing, or trying to get pregnant.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Musculoskeletal symptom presence/absence
Statin Tolerance
Variables associated with statin intolerance
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Placebo taken first, drug taken secondExperimental Treatment2 Interventions
The placebo is assigned to the patient first, with the medication taken in the second part of participation.
Group II: Drug taken first, then placebo taken secondExperimental Treatment2 Interventions
The placebo is assigned to the patient first, with the medication taken in the second part of participation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Closest Location:Minneapolis Heart Institute Foundation· Minneapolis, MN· 553 miles
Who is running the clinical trial?
Minneapolis Heart Institute FoundationLead Sponsor
31 Previous Clinical Trials
15,631 Total Patients Enrolled