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NCT Number: NCT00690937

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

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Diacon Hospital and Research Center, Bangalore, India

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enteric coated sevelamer

Drug

Drug treatment

Other names: ECS

Colesevelam Cholestagel

Drug

Drug comparator

Placebo

Drug

Placebo

Primary outcomes

  1. The primary safety endpoints are: The type and number of AEs and proportion of patients with AEs.

    Time frame: throughout study

  2. Assessment of clinical laboratory parameters including blood chemistry, liver function tests, and renal function tests and hematology (CBC).

    Time frame: throughout study

  3. The primary efficacy endpoint is: The percent change in LDL cholesterol from baseline.

    Time frame: From baseline to Day 42

Secondary outcomes

  1. The secondary efficacy endpoints are: the absolute change in LDL cholesterol from baseline.

    Time frame: From baseline to Day 42

  2. The percent change in total cholesterol, HDL cholesterol and triglycerides from baseline.

    Time frame: From baseline to Day 42

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Collaborators

  • Manipal Acunova Ltd.

Registry information

Official study 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

Acronym: Sevelamer ECS

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 5, 2008
Registry last updated
Mar 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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