Status:
COMPLETED
A Multicenter, Active and Placebo-controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate Hypercholesteremia
Lead Sponsor:
Genzyme, a Sanofi Company
Collaborating Sponsors:
Manipal Acunova Ltd.
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 treatmen...
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...
Eligibility Criteria
Inclusion
- 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
- Women who are pregnant or lactating.
- Patients using other lipid-lowering medications during .
- Patients with unstable medical conditions and/or comorbidities
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00690937
Start Date
February 1 2008
End Date
December 1 2008
Last Update
March 19 2014
Active Locations (8)
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1
Diacon Hospital and Research Center
Bangalore, India
2
M S Ramaiah Medical College and Memorial Hospital
Bangalore, India
3
Appollo first Med Hospital
Chennai, India
4
Associates in Clinical Endocronolgy Education & Research (ACEER)
Chennai, India