A Multicenter, Active and Placebo-Controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate Hypercholesteremia - Tabular View

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A Multicenter, Active and Placebo-Controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate Hypercholesteremia (Sevelamer ECS)

This study is currently recruiting participants.

Study NCT00690937. Last updated on August 1, 2008. Information provided by Genzyme

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

A Multicenter, Active and Placebo-Controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate Hypercholesteremia

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 Hypercholesterolemia

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 Description

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

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

The primary safety endpoints are: The type and number of AEs and proportion of patients with AEs. [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
Assessment of clinical laboratory parameters including blood chemistry, liver function tests, and renal function tests and hematology (CBC). [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
The primary efficacy endpoint is: The percent change in LDL cholesterol from baseline. [ Time Frame: From baseline to Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

The secondary efficacy endpoints are: the absolute change in LDL cholesterol from baseline. [ Time Frame: From baseline to Day 42 ] [ Designated as safety issue: No ]
The percent change in total cholesterol, HDL cholesterol and triglycerides from baseline. [ Time Frame: From baseline to Day 42 ] [ Designated as safety issue: No ]

Condition ^†

Hypercholesterolemia

Intervention ^†

Drug: Enteric coated sevelamer
Drug: Colesevelam Cholestagel
Drug: Placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

120

Start Date ^†

February 2008

Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Males and females 18 years of age or older
Clinical diagnosis of mild to moderate hypercholesterolemia 1)LDL cholesterol greater than or equal to 130 mg/dL and less than or equal to 220 mg/dL 2) Triglycerides less than or equal to 300 mg/dL

Exclusion Criteria:

Women who are pregnant or lactating.
Patients using other lipid-lowering medications during .
Patients with unstable medical conditions and/or comorbidities

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Medical Information

617-252-7832

medinfo@genzyme.com

Location Countries ^†

India

Administrative Information Fields

NCT ID ^†

NCT00690937

Organization ID

ECS00107

Secondary IDs ^††

ELLS

Study Sponsor ^†

Genzyme

Collaborators ^††

Manipal AcuNova Limited, Bangalore, India

Investigators ^†

Study Director:

Dr. Jayashee;, MD

Medical Monitor, Manipal AcuNova Limited Bangalore, India (CRO)

Information Provided By

Genzyme

Verification Date

July 2008

First Received Date ^†

June 3, 2008

Last Updated Date

August 1, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.