| Trial ID: | L1351 |
| Source ID: | NCT02282813
|
| Associated Drug: |
Ctap101 Capsules
|
| Title: |
Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02282813/results
|
| Conditions: |
Chronic Kidney Disease|Hyperparathyroidism, Secondary|Vitamin D Deficiency
|
| Interventions: |
DRUG: CTAP101 Capsules|DRUG: Calcitriol|DRUG: Doxercalciferol|DRUG: Paricalcitol
|
| Outcome Measures: |
Primary: Number of Participants in the Intent to Treat Population With a Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT), Number of subjects in the intent to treat population with a mean reduction in plasma intact parathyroid hormone (iPTH) of \>/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders, up to 6 months | Secondary: Number of Participants in the Per Protocol Population With Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT), Number of subjects in the per protocol population with a mean reduction in plasma intact parathyroid hormone (iPTH) of \>/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders, up to 6 months|Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT), Number of Participants in the Intent to Treat Population with serum 25-hydroxyvitamin D \>/= 30 ng/mL at End of Treatment (EOT), up to 6 months|Number of Participants in the Per Protocol Population With NormalSerum 25-hydroxyvitamin D at End of Treatment (EOT), Number of Participants in the per protocol population with serum 25-hydroxyvitamin D \>/= 30 ng/mL at End of Treatment (EOT), up to 6 months
|
| Sponsor/Collaborators: |
Sponsor: OPKO Health, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
298
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-04
|
| Completion Date: |
2015-05
|
| Results First Posted: |
2016-08-17
|
| Last Update Posted: |
2016-09-29
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT02282813
|
