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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Placebo; Drug: Enteric coated sevelamer; Drug: Colesevelam Cholestagel

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1 ECS; Low dose treatment	Drug: Enteric coated sevelamer; Drug treatment; Other Names: ECS
EXPERIMENTAL: 2 ECS; High dose treatment	Drug: Enteric coated sevelamer; Drug treatment; Other Names: ECS
ACTIVE_COMPARATOR: 3 Colesevelam; Active control treatment	Drug: Colesevelam Cholestagel; Drug comparator
PLACEBO_COMPARATOR: 4 Placebo; Placebo matched to low dose treatment	Drug: Placebo; Placebo
PLACEBO_COMPARATOR: 5 Placebo; Placebo matched to high dose treatment	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary efficacy endpoints are: the absolute change in LDL cholesterol from baseline.	From baseline to Day 42
The percent change in total cholesterol, HDL cholesterol and triglycerides from baseline.	From baseline to Day 42

Collaborators and Investigators

• Sponsor: Genzyme, a Sanofi Company
• Collaborators: Manipal Acunova Ltd.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: June 3, 2008
• First Submitted That Met QC Criteria: June 4, 2008
• First Posted (ESTIMATE): June 5, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): March 19, 2014
• Last Update Submitted That Met QC Criteria: March 17, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: hypercholesterolemia, bile acid sequestrant, LDL-cholesterol
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Chelating Agents; Sequestering Agents; Sevelamer; Colesevelam Hydrochloride
• Other Study ID Numbers: ECS00107; ELLS