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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00690937
Recruitment Status : Completed
First Posted : June 5, 2008
Last Update Posted : March 19, 2014
Sponsor:
Collaborator:
Manipal Acunova Ltd.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE June 3, 2008
First Posted Date  ICMJE June 5, 2008
Last Update Posted Date March 19, 2014
Study Start Date  ICMJE February 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2008)
  • The primary safety endpoints are: The type and number of AEs and proportion of patients with AEs. [ Time Frame: throughout study ]
  • Assessment of clinical laboratory parameters including blood chemistry, liver function tests, and renal function tests and hematology (CBC). [ Time Frame: throughout study ]
  • The primary efficacy endpoint is: The percent change in LDL cholesterol from baseline. [ Time Frame: From baseline to Day 42 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00690937 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2008)
  • The secondary efficacy endpoints are: the absolute change in LDL cholesterol from baseline. [ Time Frame: From baseline to Day 42 ]
  • The percent change in total cholesterol, HDL cholesterol and triglycerides from baseline. [ Time Frame: From baseline to Day 42 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter, Active and Placebo-controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate Hypercholesteremia
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Drug: Enteric coated sevelamer
    Drug treatment
    Other Name: ECS
  • Drug: Enteric coated sevelamer
    Drug treatment
  • Drug: Colesevelam Cholestagel
    Drug comparator
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: 1 ECS
    Low dose treatment
    Intervention: Drug: Enteric coated sevelamer
  • Experimental: 2 ECS
    High dose treatment
    Intervention: Drug: Enteric coated sevelamer
  • Active Comparator: 3 Colesevelam
    Active control treatment
    Intervention: Drug: Colesevelam Cholestagel
  • Placebo Comparator: 4 Placebo
    Placebo matched to low dose treatment
    Intervention: Drug: Placebo
  • Placebo Comparator: 5 Placebo
    Placebo matched to high dose treatment
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2008)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00690937
Other Study ID Numbers  ICMJE ECS00107
ELLS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Genzyme, a Sanofi Company )
Study Sponsor  ICMJE Genzyme, a Sanofi Company
Collaborators  ICMJE Manipal Acunova Ltd.
Investigators  ICMJE
Study Director: Medical Monitor Genzyme, a Sanofi Company
PRS Account Sanofi
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP