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| ID | Type | Description | Link |
|---|---|---|---|
| ELLS |
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| Name | Class |
|---|---|
| Manipal Acunova Ltd. | NETWORK |
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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.
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:
The efficacy parameters include a fasting lipid profile:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 ECS | Experimental | Low dose treatment |
|
| 2 ECS | Experimental | High dose treatment |
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| 3 Colesevelam | Active Comparator | Active control treatment |
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| 4 Placebo | Placebo Comparator | Placebo matched to low dose treatment |
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| 5 Placebo | Placebo Comparator | Placebo matched to high dose treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteric coated sevelamer | Drug | Drug treatment |
|
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| Measure | Description | Time Frame |
|---|---|---|
| The primary safety endpoints are: The type and number of AEs and proportion of patients with AEs. | throughout study | |
| Assessment of clinical laboratory parameters including blood chemistry, liver function tests, and renal function tests and hematology (CBC). | throughout study | |
| The primary efficacy endpoint is: The percent change in LDL cholesterol from baseline. | From baseline to Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary efficacy endpoints are: the absolute change in LDL cholesterol from baseline. | From baseline to Day 42 | |
| The percent change in total cholesterol, HDL cholesterol and triglycerides from baseline. | From baseline to Day 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diacon Hospital and Research Center | Bangalore | India | ||||
| M S Ramaiah Medical College and Memorial Hospital |
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| Enteric coated sevelamer | Drug | Drug treatment |
|
| Colesevelam Cholestagel | Drug | Drug comparator |
|
| Placebo | Drug | Placebo |
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| Placebo | Drug | Placebo |
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| Bangalore |
| India |
| Appollo first Med Hospital | Chennai | India |
| Associates in Clinical Endocronolgy Education & Research (ACEER) | Chennai | India |
| Care Hospital | Hyderabad | India |
| Diabetes Endocrine Nutrition Management and Research Center | Mumbai | India |
| P D Hinduja National Hospital and Medical Research Centre | Mumbai | India |
| Indraprastha Apollo Hospitals | New Delhi | India |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069472 | Colesevelam Hydrochloride |
| ID | Term |
|---|---|
| D000499 | Allylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000498 | Allyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
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