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

This study has been completed.
Sponsor:
Collaborator:
Manipal Acunova Ltd.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00690937
First received: June 3, 2008
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Drug: Enteric coated sevelamer
Drug: Colesevelam Cholestagel
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Enrollment: 120
Study Start Date: February 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 ECS
Low dose treatment
Drug: Enteric coated sevelamer
Drug treatment
Other Name: ECS
Experimental: 2 ECS
High dose treatment
Drug: Enteric coated sevelamer
Drug treatment
Other Name: Enteric coated sevelamer
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690937

Locations
India
M S Ramaiah Medical College and Memorial Hospital
Bangalore, India
Diacon Hospital and Research Center
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, India
Sponsors and Collaborators
Genzyme, a Sanofi Company
Manipal Acunova Ltd.
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00690937     History of Changes
Other Study ID Numbers: ECS00107, ELLS
Study First Received: June 3, 2008
Last Updated: March 17, 2014
Health Authority: India: Central Drugs Standard Control Organization

Keywords provided by Sanofi:
hypercholesterolemia, bile acid sequestrant, LDL-cholesterol

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Sevelamer
Colesevelam
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014