A Multicenter, Active and Placebo-Controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate Hypercholesteremia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: Enteric coated sevelamer Drug: Colesevelam Cholestagel Drug: Placebo	Phase II

Genetics Home Reference related topics:

hypercholesterolemia

MedlinePlus related topics:

Cholesterol

ChemIDplus related topics:

Sevelamer Sevelamer carbonate Sevelamer hydrochloride Cholest-5-en-3-ol (3beta)- Colesevelam GT31-104

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Genzyme:

Primary Outcome Measures:

The primary safety endpoints are: The type and number of AEs and proportion of patients with AEs. [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
Assessment of clinical laboratory parameters including blood chemistry, liver function tests, and renal function tests and hematology (CBC). [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
The primary efficacy endpoint is: The percent change in LDL cholesterol from baseline. [ Time Frame: From baseline to Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary efficacy endpoints are: the absolute change in LDL cholesterol from baseline. [ Time Frame: From baseline to Day 42 ] [ Designated as safety issue: No ]
The percent change in total cholesterol, HDL cholesterol and triglycerides from baseline. [ Time Frame: From baseline to Day 42 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	February 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 ECS: Experimental Low dose treatment	Drug: Enteric coated sevelamer Drug treatment
2 ECS: Experimental High dose treatment	Drug: Enteric coated sevelamer Drug treatment
3 Colesevelam: Active Comparator Active control treatment	Drug: Colesevelam Cholestagel Drug comparator
4 Placebo: Placebo Comparator Placebo matched to low dose treatment	Drug: Placebo Placebo
5 Placebo: Placebo Comparator Placebo matched to high dose treatment	Drug: Placebo Placebo

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690937

Contacts


Contact: Medical Information	617-252-7832	medinfo@genzyme.com

Locations


India
	Appollo first Med Hospital	Recruiting
	Chennai, India
	Contact: Dr. TV Devarajan, M.B.B.S 044-2829333 scrc@vsnl.net
	Contact: Ms. Mythili, Masters in Microbiology 044-2829333 aherf_chennai@appollohospitals.com
	Diabetes Endocrine Nutrition Management and Research Center	Recruiting
	Mumbai, India
	Contact: Dr. HB Chandalia, M.B.B.S 022-22840244/ 22840255 denmarc100@rediffmail.com
	Contact: Ms. Rishika Jain, Masters in Microbiology 022-22840244 denmarc100@rediffmail.com
	P D Hinduja National Hospital and Medical Research Centre	Recruiting
	Mumbai, India
	Contact: Dr. Phulrenu Chauhan, M.B.B.S 022-24440425 chauhanph@rediffmail.com
	Contact: Dr. Girish, M.B.B.S 022-24440425
	Care Hospital	Recruiting
	Hyderabad, India
	Contact: Dr. Bipin Kumar Sethi, M.B.B.S 040-66668888 ext 125/123
	Contact: Mr. Mithelesh, Masters in Biochemistry 040-66668888 mmithilesh@gmail.com
	Associates in Clinical Endocronolgy Education & Research (ACEER)	Recruiting
	Chennai, India
	Contact: Dr. V. Kumaravel 044-24460762 aceer_chennai@yahoo.com
	Contact: Dr. Rekha V. Bhat 9840976248 aceergroup@gmail.com
	M S Ramaiah Medical College and Memorial Hospital	Recruiting
	Bangalore, India
	Contact: Dr. Mala Dharmalingam, M.B.B.S 080-40149999 mala_endo@rediffmail.com
	Contact: Mr. Gururaj, Masters in Microbiology 080-40149999 gururaj.gm@metropolisindia.com
	Diacon Hospital and Research Center	Recruiting
	Bangalore, India
	Contact: Dr. Aravind S. R. 080-23131166 diaconhospital@gmail.com
	Contact: Dr. Sunitha 080-23124404, 9845824181
	Indraprastha Apollo Hospitals	Recruiting
	New Delhi, India
	Contact: Dr. SK Wangnoo, M.B.B.S 011-26925025 subhashwang@hotmail.com
	Contact: Ms. Shaveta Gupta, Masters in Clinical Research 011-26925825 aherfdelhi@gmail.com

Sponsors and Collaborators

Genzyme

Manipal AcuNova Limited, Bangalore, India

Investigators


Study Director:	Dr. Jayashee;, MD	Medical Monitor, Manipal AcuNova Limited Bangalore, India (CRO)

More Information

Responsible Party:	Genzyme Corporation ( Medical Monitor )
Study ID Numbers:	ECS00107, ELLS
First Received:	June 3, 2008
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00690937
Health Authority:	India: Central Drugs Standard Control Organization

Keywords provided by Genzyme:

hypercholesterolemia, bile acid sequestrant, LDL-cholesterol

Study placed in the following topic categories:

Sevelamer

Colesevelam

Metabolic Diseases

Hyperlipidemias

Metabolic disorder

Hypercholesterolemia

Dyslipidemias

Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Anticholesteremic Agents

Chelating Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Genzyme Manipal AcuNova Limited, Bangalore, India
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00690937