Who is sponsoring Sevelamer ECS?

Sevelamer ECS is sponsored by Genzyme, a Sanofi Company.

What condition does Sevelamer ECS study?

Sevelamer ECS studies Hypercholesterolemia.

What drugs are being tested in Sevelamer ECS?

Interventions: Enteric coated sevelamer, Enteric coated sevelamer, Colesevelam Cholestagel, Placebo, Placebo.

What is the status of Sevelamer ECS?

Sevelamer ECS is currently COMPLETED.

Last reviewed 2014-03-17 · How we verify

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 Hypercholesterolemia (Sevelamer ECS)

NCT00690937 Phase 2 COMPLETED

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.

Details

Lead sponsor	Genzyme, a Sanofi Company
Phase	Phase 2
Status	COMPLETED
Enrolment	120
Start date	2008-02
Completion	2008-12

Conditions

Hypercholesterolemia

Interventions

Enteric coated sevelamer
Enteric coated sevelamer
Colesevelam Cholestagel
Placebo
Placebo

Primary outcomes

The primary safety endpoints are: The type and number of AEs and proportion of patients with AEs. — throughout study
Assessment of clinical laboratory parameters including blood chemistry, liver function tests, and renal function tests and hematology (CBC). — throughout study
The primary efficacy endpoint is: The percent change in LDL cholesterol from baseline. — From baseline to Day 42

Countries

India