Phase 4
N=134
A Study Comparing CoQ10 Levels While Taking 3 Different Statins
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT01660191 ↗Enrolled (actual)
134
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Changes in Plasma CoQ10 Levels — -96.70; -110.42; -103.91; -721.09 μg/g
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pitavastin 4mg (Drug); Atorvastatin 20mg (Drug); Rosuvastatin 5mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Plasma CoQ10 Levels |
-96.70; -110.42; -103.91; -721.09; -464.85; -642.43 | — |
| SECONDARY Changes in Major Lipid Parameters - VLDL Size |
0.68; 0.81; 3.17 | — |
| SECONDARY Changes to Glucose Metabolism - HbA1c and Insulin |
0.00; 0.00; 0.00; 0.16; 0.01; 0.17 | — |
| SECONDARY Changes in HDL and LDL Size |
0.23; 0.23; 0.12; -0.02; -0.11; -0.09 | — |
| SECONDARY Changes to Glucose Metabolism - Fructosamine |
1.91; -1.17; -3.07 | — |
| SECONDARY Changes HDL Particle Number and LDL Particle Number |
0.64; 2.55; 2.05; -873.48; -768.26; -626.61 | — |
Summary
The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin or Rosuvastatin.
Eligibility Criteria
Inclusion Criteria
- LDL-C levels of 100-200mg/dl; triglycerides 200mg/dl, Triglycerides >200mg/dl
- History of diabetes mellitus or documented fasting blood glucose >125mg/dl or HbA1c >6.4%
- History of coronary artery disease
- history of chronic renal or hepatic disease
- known sensitivity of intolerance to a statin
- persistent elevated liver enzymes or CPK (>3 x upper normal limit)
- currently taking CoQ10 supplements and unable discontinue for duration of study
Data sourced from ClinicalTrials.gov (NCT01660191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.