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| Tracking Information | |||||
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| First Received Date ICMJE | December 20, 2005 | ||||
| Last Updated Date | August 3, 2009 | ||||
| Start Date ICMJE | January 2006 | ||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00267514 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
1. Compare the effects of sevelamer carbonate powder to sevelamer hydrochloride tablets when dosed three times a day with meals on: A) serum calcium-phosphorus product B) serum lipid profile (total cholesterol, HDL and LDL). | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis Patients | ||||
| Official Title ICMJE | A Randomized, Cross-over Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer Hydrochloride Tablets Dosed Three Times Per Day in Haemodialysis Patients | ||||
| Brief Summary | The purpose of this study is to determine if sevelamer carbonate powder is an effective treatment for the control of serum phosphorous levels in patients on dialysis when compared to sevelamer hydrochloride tablets. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Randomized Control: Active Control Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Chronic Kidney Disease | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 31 | ||||
| Completion Date | May 2007 | ||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00267514 | ||||
| Responsible Party | Medical Monitor, Genzyme Corporation | ||||
| Study ID Numbers ICMJE | SVCARB00205 | ||||
| Study Sponsor ICMJE | Genzyme | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Genzyme | ||||
| Verification Date | May 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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