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

Hypercholesterolemia Clinical Trial

— Sevelamer ECS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690937
• Other study ID #: ECS00107
• Secondary ID: ELLS
• Status: Completed
• Phase: Phase 2
• First received: June 3, 2008
• Last updated: March 17, 2014
• Start date: February 2008
• Est. completion date: December 2008

Study information

• Verified date: March 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Central Drugs Standard Control Organization
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Enteric coated sevelamer
Drug treatment
• Enteric coated sevelamer
Drug treatment
• Colesevelam Cholestagel
Drug comparator
• Placebo
Placebo
• Placebo
Placebo

Locations

Country	Name	City	State
India	Diacon Hospital and Research Center	Bangalore
India	M S Ramaiah Medical College and Memorial Hospital	Bangalore
India	Appollo first Med Hospital	Chennai
India	Associates in Clinical Endocronolgy Education & Research (ACEER)	Chennai
India	Care Hospital	Hyderabad
India	Diabetes Endocrine Nutrition Management and Research Center	Mumbai
India	P D Hinduja National Hospital and Medical Research Centre	Mumbai
India	Indraprastha Apollo Hospitals	New Delhi

Sponsors (2)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company	Manipal Acunova Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary safety endpoints are: The type and number of AEs and proportion of patients with AEs.		throughout study	Yes
Primary	Assessment of clinical laboratory parameters including blood chemistry, liver function tests, and renal function tests and hematology (CBC).		throughout study	Yes
Primary	The primary efficacy endpoint is: The percent change in LDL cholesterol from baseline.		From baseline to Day 42	No
Secondary	The secondary efficacy endpoints are: the absolute change in LDL cholesterol from baseline.		From baseline to Day 42	No
Secondary	The percent change in total cholesterol, HDL cholesterol and triglycerides from baseline.		From baseline to Day 42	No