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
2 other identifiers
interventional
120
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2008
Shorter than P25 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 3, 2008
CompletedFirst Posted
Study publicly available on registry
June 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedMarch 19, 2014
March 1, 2014
10 months
June 3, 2008
March 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
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
Study Arms (5)
1 ECS
EXPERIMENTALLow dose treatment
2 ECS
EXPERIMENTALHigh dose treatment
3 Colesevelam
ACTIVE COMPARATORActive control treatment
4 Placebo
PLACEBO COMPARATORPlacebo matched to low dose treatment
5 Placebo
PLACEBO COMPARATORPlacebo matched to high dose treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Women who are pregnant or lactating.
- Patients using other lipid-lowering medications during .
- Patients with unstable medical conditions and/or comorbidities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genzyme, a Sanofi Companylead
- Manipal Acunova Ltd.collaborator
Study Sites (8)
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, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2008
First Posted
June 5, 2008
Study Start
February 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
March 19, 2014
Record last verified: 2014-03