DESIFOR-EXPAND (MHIF)

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Minneapolis Heart Institute Foundation
Study ID
NCT06804980
Phase
PHASE4
Status
Recruiting
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Conditions

  • Statin
  • Statin Adverse Reaction
  • Statin Therapy

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rosuvastatin (Crestor) — DRUG
    The patient will take 3 28-day packs of placebo and 2 28-day packs of rosuvastatin. The order in which they take the placebo or rosuvastatin will be assigned at random.
  • Placebo — DRUG
    The patient will take 3 28-day packs of placebo and 2 28-day packs of rosuvastatin. The order in which they take the placebo or rosuvastatin will be assigned at random.

Study Details

The DESIFOR pilot study was conducted to determine the feasibility of utilizing an n-of-1 trial to facilitate tolerance of unblinded rosuvastatin in patients with prior statin intolerance

Key Dates

Start date
Feb 1, 2025
Status verified
Jan 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Placebo taken first, drug taken second
    The placebo is assigned to the patient first, with the medication taken in the second part of participation.
  • Other: Drug taken first, then placebo taken second
    The placebo is assigned to the patient first, with the medication taken in the second part of participation.

Primary Outcome Measure

Musculoskeletal symptom presence/absence [ Time Frame: 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407-

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Minneapolis Heart Institute Foundation· Minneapolis, MN

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