HypercholesterolemiaPhase 2Sevelamer ECSNCT00690937
A Multicenter, Active and Placebo-controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate Hypercholesteremia
A Phase 2 study testing Enteric coated sevelamer and Colesevelam Cholestagel in people with Hypercholesterolemia, run by Genzyme, a Sanofi Company at 8 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Enteric coated sevelamer and Colesevelam Cholestagel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 8 sitesIndia
- Study dates
- Feb 2008to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women who are pregnant or lactating.
- Patients using other lipid-lowering medications during .
- Patients with unstable medical conditions and/or comorbidities
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
India8 sites
Diacon Hospital and Research Center
Bangalore
M S Ramaiah Medical College and Memorial Hospital
Bangalore
Appollo first Med Hospital
Chennai
Associates in Clinical Endocronolgy Education & Research (ACEER)
Chennai
Care Hospital
Hyderabad
Diabetes Endocrine Nutrition Management and Research Center
Mumbai
P D Hinduja National Hospital and Medical Research Centre
Mumbai
Indraprastha Apollo Hospitals
New Delhi
About this 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
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.
Read the 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
- Conditions
- Hypercholesterolemia
- Being tested
- Enteric coated sevelamer, Colesevelam Cholestagel, Placebo
- Keywords
- hypercholesterolemia, bile acid sequestrant, LDL-cholesterol
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteric coated sevelamerDrug
Also called ECS
Drug treatment
Enteric coated sevelamerDrug
Drug treatment
Colesevelam CholestagelDrug
Drug comparator
PlaceboDrug
Placebo
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 ECS | Experimental | Low dose treatment Receives: Drug: Enteric coated sevelamer |
| 2 ECS | Experimental | High dose treatment Receives: Drug: Enteric coated sevelamer |
| 3 Colesevelam | Active comparator | Active control treatment Receives: Drug: Colesevelam Cholestagel |
| 4 Placebo | Placebo comparator | Placebo matched to low dose treatment Receives: Drug: Placebo |
| 5 Placebo | Placebo comparator | Placebo matched to high dose treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary safety endpoints are: The type and number of AEs and proportion of patients with AEs.
Measured: throughout study
Assessment of clinical laboratory parameters including blood chemistry, liver function tests, and renal function tests and hematology (CBC).
Measured: throughout study
The primary efficacy endpoint is: The percent change in LDL cholesterol from baseline.
Measured: From baseline to Day 42
Secondary outcomes (2)
The secondary efficacy endpoints are: the absolute change in LDL cholesterol from baseline.
Measured: From baseline to Day 42
The percent change in total cholesterol, HDL cholesterol and triglycerides from baseline.
Measured: From baseline to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Manipal Acunova Ltd.
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690937
- Sponsor's protocol ID
- ECS00107
- Other IDs
- ELLS
- Acronym
- Sevelamer ECS
- Status last verified
- Mar 2014
- First submitted
- 3 Jun 2008
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00690937
- Acronym / sponsor ID
- Sevelamer ECS / ECS00107
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, bile acid sequestrant, LDL-cholesterol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Manipal Acunova Ltd.
- Study start
- Feb 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 ECS | Experimental | Drug: Enteric coated sevelamerLow dose treatment |
| 2 ECS | Experimental | Drug: Enteric coated sevelamerHigh dose treatment |
| 3 Colesevelam | Active comparator | Drug: Colesevelam CholestagelActive control treatment |
| 4 Placebo | Placebo comparator | Drug: PlaceboPlacebo matched to low dose treatment |
| 5 Placebo | Placebo comparator | Drug: PlaceboPlacebo matched to high dose treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Women who are pregnant or lactating.
- Patients using other lipid-lowering medications during .
- Patients with unstable medical conditions and/or comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteric coated sevelamerAlso: ECSDrug treatment | Drug | 1 ECS |
| Enteric coated sevelamerDrug treatment | Drug | 2 ECS |
| Colesevelam CholestagelDrug comparator | Drug | 3 Colesevelam |
| PlaceboPlacebo | Drug | 4 Placebo |
| PlaceboPlacebo | Drug | 5 Placebo |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Genzyme, a Sanofi Company
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enteric coated sevelamer and Colesevelam Cholestagel in people with Hypercholesterolemia, run by Genzyme, a Sanofi Company at 8 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary safety endpoints are: The type and number of AEs and proportion of patients with AEs. (time frame: throughout study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2014.