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Clinical Trial Details

Trial ID: L0908
Source ID: NCT00110890
Associated Drug: Cinacalcet
Title: A Research Study for Patients With End-Stage Renal Disease (ESRD)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00110890/results
Conditions: End Stage Renal Disease
Interventions: DRUG: cinacalcet|OTHER: Standard of care
Outcome Measures: Primary: Number of Participants With Mean PTH ≤ 300 pg/mL, Number of participants with mean parathyroid hormone (PTH) ≤ 300 pg/mL during the efficacy assessment phase, Efficacy Assessment Phase (weeks 17 to 23) | Secondary: Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL, Number of participants with mean calcium x phosphorus (Ca x P) \< 55 mg\^2/dL\^2 and intact parathyroid hormone (iPTH) ≤ 300 pg/mL during the efficacy assessment phase, Efficacy Assesment Phase (weeks 17-23)|Number of Participants With Mean Ca x P < 55 mg^2/dL^2, Number of participants with mean calcium x phosphorus (Ca x P) \< 55 mg\^2/dL\^2 during the efficacy assessment phase, Efficacy Assessment Phase (weeks 17 to 23)|Number of Participants With Mean Serum Ca < 9.5 mg/dL, Number of participants with mean serum calcium (Ca) \< 9.5 mg/dL during the efficacy assessment phase, Efficacy Assessment Phase (weeks 17-23)|Number of Participants With Mean Serum P < 5.5 mg/dL, Number of participants with mean serum phosphorus (P) \< 5.5 mg/dL during the efficacy assessment phase, Efficacy Assessment Phase (weeks 17 to 23)
Sponsor/Collaborators: Sponsor: Amgen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 552
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2004-05
Completion Date: 2007-09
Results First Posted: 2011-03-07
Last Update Posted: 2011-03-07
Locations:
URL: https://clinicaltrials.gov/show/NCT00110890