| Trial ID: | L1356 |
| Source ID: | NCT00037635
|
| Associated Drug: |
Amg 073
|
| Title: |
A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Secondary Hyperparathyroidism|End Stage Renal Disease
|
| Interventions: |
DRUG: AMG 073|DRUG: Placebo
|
| Outcome Measures: |
Primary: To evaluate the efficacy of AMG 073 compared with placebo by determining the proportion of subjects with a mean intact parathyroid hormone (iPTH) value <= 250 pg/mL (26.5 pmol/L) during the efficacy assessment phase., efficacy assessment phase (last 14 weeks of treatment) | Secondary: To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in mean calcium x phosphorus product (Ca x P) during the efficacy assessment phase, efficacy assessment phase (last 14 weeks of treatment)|To evaluate the efficacy of AMG 073 compared with placebo by determining: changes in self-reported cognitive function from baseline to the end of the efficacy assessment phase, efficacy assessment phase (last 14 weeks of treatment)|To evaluate the safety of AMG 073 compared with placebo., entire study
|
| Sponsor/Collaborators: |
Sponsor: Amgen
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
400
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2001-12
|
| Completion Date: |
2003-03
|
| Results First Posted: |
|
| Last Update Posted: |
2013-05-08
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00037635
|
