Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT01032993
Eligibility Criteria:
Inclusion Criteria:
* Patients with a history of muscle symptoms (such as aches, pains, cramps and/or weakness) while taking a statin drug that persisted for at least 2 weeks on a statin
Exclusion Criteria:
* Plasma creatine kinase levels \> 3 times the upper normal limit
* Liver enzymes, alanine transferase (ALT) or aspartate transferase (AST) \> 2 times the upper normal limit
* Pregnancy or breastfeeding (a contraindication for statin use)
* Severe renal impairment, defined as glomerular filtration rate (GFR) \< 30 ml/min/1.73 m2
* Bleeding disorder, current use of warfarin, an international normalized ratio (INR) greater than 1.5, or a platelet count less than 100,000 mm3
* Contraindication to strength testing, including myocardial infarction, unstable angina, or revascularization procedure within the past six weeks, a history of brain aneurysm or stroke
* Chest or abdominal surgery within the past six weeks
* Severe persistent pain related to other causes
* Unable to complete self-administered questionnaires, or unable to read or converse in English
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01032993
Study Brief:
Protocol Section:
NCT01032993