Subjects for whom statin intake is a necessary therapeutic intervention i.e diabetics, dyslipidemics and patients with ischaemic heart disease.
Conditions
Interventions
Trade Name: LIPITOR
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: atorvastatin calcium
CAS Number: 134523-03-8
Current Sponsor code: n/a
Other descriptive name: n/a
Concentration unit:
Sponsors
Sligo General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Individuals for whom intake of statin (ATORVASTATIN) is necessary as therapeutic intervention b. Age 18 – 80 years old c. Previous history of muscular related adverse reactions excluding rhabdomyolysis d. Females: Post-menopausal, otherwise female using effective barrier contraception or is surgically sterilised Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. Previous history of rhabdomyolysis/angioedema associated with statin therapy b. Hepatic and renal failure c. Females who are pregnant or are planning pregnancy or are breastfeeding d. Alcohol abuse e. Patients who are enrolled in another clinical trial or who have been enrolled in a clinical trial in the 12 weeks preceding the study f. Patients on acid lowering drugs (H2 antagonistis/proton pump inhibitor) or an antacids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether or not the intake of ubiquinone with result in the resolution of fatigue and myopathy (muscle pain, tiredness, weakness or cramps) associated with atorvastatin ;Secondary Objective: a. Evaluation of pyruvate / lactate ratio in relation to fatique and myopathy b. Evaluate safety and toleratbility of coadminstration of atorvastatin with ubiquione ;Primary end point(s): Resolution of fatigue and myopathy (muscle pain, tiredness, weakness or cramps) associated with atorvastatin intake by ubiquinone | — |
Countries
Ireland
Outcome results
None listed