A study to determine whether myalgia is due to statin use

Phase 4

Active, not recruiting

• Conditions: Statin-induced myalgia; Cardiovascular - Other cardiovascular diseases; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12616001168448
• Lead Sponsor: The George Institue for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Has indication for statin therapy;
History of intolerance of both atorvastatin 10 mg AND rosuvastatin 5 mg monotherapy;
History of statin-related myalgia occuring within three weeks of starting statin therapy and consequently discontinued statin use;
Without clinically significant CK elevations, <3x the upper limit of normal or <3x times the baseline value
Willing to restart statin therapy.

Exclusion Criteria

Pregnancy;
History of alcohol and/or drug abuse;
Hypothyroidism;
Renal function impairment;
Liver obstructions, patients with elevated liver enzymes (up to 3 times)
History of rhabdomyolysis;
History of metabolic or inflammatory myopathy;
History of neuropathy;
Unlikely to comply with the demands of N-of-1 trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified