| Trial ID: | L0096 |
| Source ID: | NCT00042432
|
| Associated Drug: |
Cinacalcet (Amg 073)
|
| Title: |
Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00042432/results
|
| Conditions: |
Secondary Hyperparathyroidism|Chronic Renal Insufficiency
|
| Interventions: |
DRUG: cinacalcet (AMG 073)
|
| Outcome Measures: |
Primary: Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase, Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase, Efficacy assessment phase (weeks 12-18) | Secondary: Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase, Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase, Baseline, efficacy assessment phase (weeks 12-18)
|
| Sponsor/Collaborators: |
Sponsor: Amgen
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
54
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2002-06
|
| Completion Date: |
2003-08
|
| Results First Posted: |
2011-03-01
|
| Last Update Posted: |
2013-05-13
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00042432
|
