Back to resultsA Multicenter, Active and Placebo-controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate Hypercholesteremia (Sevelamer ECS)
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Enteric coated sevelamer
Enteric coated sevelamer
Colesevelam Cholestagel
Placebo
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring hypercholesterolemia, bile acid sequestrant, LDL-cholesterol
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
Sites / Locations
- Diacon Hospital and Research Center
- M S Ramaiah Medical College and Memorial Hospital
- Appollo first Med Hospital
- Associates in Clinical Endocronolgy Education & Research (ACEER)
- Care Hospital
- Diabetes Endocrine Nutrition Management and Research Center
- P D Hinduja National Hospital and Medical Research Centre
- Indraprastha Apollo Hospitals
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Placebo Comparator
Arm Label
1 ECS
2 ECS
3 Colesevelam
4 Placebo
5 Placebo
Arm Description
Low dose treatment
High dose treatment
Active control treatment
Placebo matched to low dose treatment
Placebo matched to high dose treatment
Outcomes
Primary Outcome Measures
The primary safety endpoints are: The type and number of AEs and proportion of patients with AEs.
Assessment of clinical laboratory parameters including blood chemistry, liver function tests, and renal function tests and hematology (CBC).
The primary efficacy endpoint is: The percent change in LDL cholesterol from baseline.
Secondary Outcome Measures
The secondary efficacy endpoints are: the absolute change in LDL cholesterol from baseline.
The percent change in total cholesterol, HDL cholesterol and triglycerides from baseline.
Full Information
NCT ID
NCT00690937
First Posted
June 3, 2008
Last Updated
March 17, 2014
Sponsor
Genzyme, a Sanofi Company
Collaborators
Manipal Acunova Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00690937
Brief Title
A Multicenter, Active and Placebo-controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate Hypercholesteremia
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company
Collaborators
Manipal Acunova Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
hypercholesterolemia, bile acid sequestrant, LDL-cholesterol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 ECS
Arm Type
Experimental
Arm Description
Low dose treatment
Arm Title
2 ECS
Arm Type
Experimental
Arm Description
High dose treatment
Arm Title
3 Colesevelam
Arm Type
Active Comparator
Arm Description
Active control treatment
Arm Title
4 Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matched to low dose treatment
Arm Title
5 Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matched to high dose treatment
Intervention Type
Drug
Intervention Name(s)
Enteric coated sevelamer
Other Intervention Name(s)
ECS
Intervention Description
Drug treatment
Intervention Type
Drug
Intervention Name(s)
Enteric coated sevelamer
Intervention Description
Drug treatment
Intervention Type
Drug
Intervention Name(s)
Colesevelam Cholestagel
Intervention Description
Drug comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
The primary safety endpoints are: The type and number of AEs and proportion of patients with AEs.
Time Frame
throughout study
Title
Assessment of clinical laboratory parameters including blood chemistry, liver function tests, and renal function tests and hematology (CBC).
Time Frame
throughout study
Title
The primary efficacy endpoint is: The percent change in LDL cholesterol from baseline.
Time Frame
From baseline to Day 42
Secondary Outcome Measure Information:
Title
The secondary efficacy endpoints are: the absolute change in LDL cholesterol from baseline.
Time Frame
From baseline to Day 42
Title
The percent change in total cholesterol, HDL cholesterol and triglycerides from baseline.
Time Frame
From baseline to Day 42
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Diacon Hospital and Research Center
City
Bangalore
Country
India
Facility Name
M S Ramaiah Medical College and Memorial Hospital
City
Bangalore
Country
India
Facility Name
Appollo first Med Hospital
City
Chennai
Country
India
Facility Name
Associates in Clinical Endocronolgy Education & Research (ACEER)
City
Chennai
Country
India
Facility Name
Care Hospital
City
Hyderabad
Country
India
Facility Name
Diabetes Endocrine Nutrition Management and Research Center
City
Mumbai
Country
India
Facility Name
P D Hinduja National Hospital and Medical Research Centre
City
Mumbai
Country
India
Facility Name
Indraprastha Apollo Hospitals
City
New Delhi
Country
India
12. IPD Sharing Statement
Learn more about this trial
A Multicenter, Active and Placebo-controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate Hypercholesteremia
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