Clinical Trial: A Multicenter, Active and Placebo-controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate Hypercholesteremia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Single-blind, Active and Placebo-controlled, Parallel-group, Randomized Study of Two Dosing Regimens of Enteric Coated Sevelamer in Patients With Mild to Moderate
Brief Summary: A total of 120 patients will be entered in this study to assess the safety and efficacy of enteric coated sevelamer (ECS) to lower LDL cholesterol. Patients will be randomized into two active treatment groups, two placebo groups and one active control group.
Detailed Summary:
This is a prospective, randomized, single blind, active and placebo-controlled, parallel-group, multi-center study.
Two groups of ECS consisting of 3 and 6 tablets/day (n=30), two placebo groups of 3 and 6 tablets/day (n=15 each) and one active control group of colesevelam 6 tablets/day (n=30). The study is being conducted solely in India and there will be a total of 6-8 sites.
The safety parameters are:
- Serious adverse events SAEs
- Treatment and non-treatment emergent AEs
- Physical exams and vital signs
- Clinical safety laboratories
The efficacy parameters include a fasting lipid profile:
- Low density lipoproteins (LDL)
- Total cholesterol
- High density lipoproteins (HDL)
- Triglycerides
Sponsor: Genzyme, a Sanofi Company
Current Primary Outcome:
- The primary safety endpoints are: The type and number of AEs and proportion of patients with AEs. [ Time Frame: throughout study ]
- Assessment of clinical laboratory parameters including blood chemistry, liver function tests, and renal function tests and hematology (CBC). [ Time Frame: throughout study ]
- The primary efficacy endpoint is: The percent change in LDL cholesterol from baseline. [ Time Frame: From baseline to Day 42 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The secondary efficacy endpoints are: the absolute change in LDL cholesterol from baseline. [ Time Frame: From baseline to Day 42 ]
- The percent change in total cholesterol, HDL cholesterol and triglycerides from baseline. [ Time Frame: From baseline to Day 42 ]
Original Secondary Outcome: Same as current
Information By: Sanofi
Dates:
Date Received: June 3, 2008
Date Started: February 2008
Date Completion:
Last Updated: March 17, 2014
Last Verified: March 2014