| Trial ID: | L1491 |
| Source ID: | NCT00990704
|
| Associated Drug: |
Paricalcitol
|
| Title: |
Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00990704/results
|
| Conditions: |
Secondary Hyperparathyroidism|Hemodialysis
|
| Interventions: |
DRUG: paricalcitol|DRUG: maxacalcitol
|
| Outcome Measures: |
Primary: The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks., Baseline and the last 3 weeks (Weeks 11, 12, and 13) | Secondary: The Percentage of Participants With iPTH Within Target Range of 60-180 pg/mL, Based on the Average iPTH Obtained in the Last 3 Weeks, During the last 3 weeks (Weeks 11, 12, and 13)|Mean iPTH at Each Visit, Screening (up to 2 weeks before Baseline) to Week 13|Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks, Baseline and the last 3 weeks (Weeks 11, 12, and 13)|Percentage of Participants With a >= 50% Reduction in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks and Without Hypercalcemia During Treatment, Hypercalcemia was defined as at least 1 corrected calcium \> 11.5 mg/dL or at least 2 consecutive corrected calcium \>= 11.0 mg/dL., Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia|Percentage of Participants With iPTH Within the Target Range of 60-180 pg/mL Based on the Average iPTH Obtained in the Last 3 Weeks of the Study and Without Hypercalcemia Anytime During Treatment, Hypercalcemia was defined as at least 1 corrected calcium \> 11.5 mg/dL or at least 2 consecutive corrected calcium \>= 11.0 mg/dL., Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia|Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline, Over the 12-week treatment period|Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH, Over the 12-week treatment period
|
| Sponsor/Collaborators: |
Sponsor: Abbott
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
47
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-10
|
| Completion Date: |
2010-05
|
| Results First Posted: |
2011-06-17
|
| Last Update Posted: |
2011-07-11
|
| Locations: |
Site Ref # / Investigator 53794, Anjo, Japan|Site Ref # / Investigator 53787, Chiba, Japan|Site Ref # / Investigator 53786, Kumagaya, Japan|Site Ref # / Investigator 53792, Matsumoto, Japan|Site Ref # / Investigator 53784, Mito, Japan|Site Ref # / Investigator 53796, Nagasaki, Japan|Site Ref # / Investigator 53795, Osaka, Japan|Site Ref # / Investigator 21561, Sapporo, Japan|Site Ref # / Investigator 53789, Tokyo, Japan|Site Ref # / Investigator 53790, Tokyo, Japan|Site Ref # / Investigator 53793, Toyohashi, Japan|Site Ref # / Investigator 53785, Tsuchiura, Japan|Site Ref # / Investigator 53788, Yachiyo, Japan|Site Ref # / Investigator 53791, Yokosuka, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT00990704
|
