Clinical Trial Details
| Trial ID: | L0542 |
| Source ID: | NCT01069692 |
| Associated Drug: | Sbr759a |
| Title: | Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients |
| Acronym: | SBR759 |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Hyperphosphatemia|Chronic Kidney Disease |
| Interventions: | DRUG: SBR759A|DRUG: SBR759A|DRUG: SBR759A|DRUG: SBR759A|DRUG: SBR759A |
| Outcome Measures: | Primary: Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment, 6 weeks | Secondary: Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment, 6 weeks|Evaluate dose-dependent efficacy of SBR759, 6 weeks|Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo, 6 weeks |
| Sponsor/Collaborators: | Sponsor: Novartis |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 115 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2010-02 |
| Completion Date: | |
| Results First Posted: | |
| Last Update Posted: | 2020-12-19 |
| Locations: | Novartis Investigative Site, Jette, 1090, Belgium|Novartis Investigative Site, Liege, 4000, Belgium|Novartis Investigative Site, Roeselare, 8800, Belgium|Novartis Investigative Site, Brescia, 25123, Italy|Novartis Investigative Site, Lecco, 23900, Italy|Novartis Investigator Site, Lucca, 55100, Italy|Novartis Investigative Site, Napoli, 80131, Italy|Novartis Investigative Site, Pavia, 27100, Italy|Novartis Investigative Site, Siena, 53100, Italy |
| URL: | https://clinicaltrials.gov/show/NCT01069692 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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