Clinical trial NCT00690937: A Multicenter, Active and Placebo-controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate Hypercholesteremia
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Keywords: hypercholesterolemia, bile acid sequestrant, LDL-cholesterol
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Manipal Acunova Ltd.
First posted: 2008-06-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: The primary safety endpoints are: The type and number of AEs and proportion of patients with AEs.
timeFrame: throughout study
measure: Assessment of clinical laboratory parameters including blood chemistry, liver function tests, and renal function tests and hematology (CBC).
timeFrame: throughout study
measure: The primary efficacy endpoint is: The percent change in LDL cholesterol from baseline.
timeFrame: From baseline to Day 42
Secondary outcomes:
measure: The secondary efficacy endpoints are: the absolute change in LDL cholesterol from baseline.
timeFrame: From baseline to Day 42
measure: The percent change in total cholesterol, HDL cholesterol and triglycerides from baseline.
timeFrame: From baseline to Day 42
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Diacon Hospital and Research Center
city: Bangalore
country: India
facility: M S Ramaiah Medical College and Memorial Hospital
city: Chennai
country: India
facility: Appollo first Med Hospital
city: Chennai
country: India
facility: Associates in Clinical Endocronolgy Education & Research (ACEER)
city: Hyderabad
country: India
facility: Care Hospital
city: Mumbai
country: India
facility: Diabetes Endocrine Nutrition Management and Research Center
city: Mumbai
country: India
facility: P D Hinduja National Hospital and Medical Research Centre
city: New Delhi
country: India
facility: Indraprastha Apollo Hospitals
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: