| Trial name or title |
Efficacy and safety study of MCI‐196 versus simvastatin for dyslipidaemia in chronic kidney disease (CKD) subjects on dialysis |
| Methods |
Phase III, multicentre, double‐blind, double‐dummy, randomised, flexible‐dose, comparative study of MCI‐196 versus simvastatin |
| Participants |
> 18 years, male or female, stable dialysis, negative pregnancy test and appropriate contraception |
| Interventions |
Simvastatin, MCl‐196, or placebo |
| Outcomes |
Change in LDL cholesterol, change in total cholesterol, HDL cholesterol, triglycerides and additional lipid parameters, change in phosphorus (P), Calcium (Ca), calcium‐phosphorus ion product (PxCa) and parathyroid hormone (PTH), vital signs, adverse events, and laboratory values |
| Starting date |
March 2009 |
| Contact information |
Mitsubishi Tanabe Pharma Corporation |
| Notes |
Unclear contact information |
