| Trial ID: | L1717 |
| Source ID: | NCT03588884
|
| Associated Drug: |
Calcifediol Oral Capsule
|
| Title: |
Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03588884/results
|
| Conditions: |
Secondary Hyperparathyroidism Due to Renal Causes|Vitamin D Insufficiency|CKD Stage 3|CKD Stage 4
|
| Interventions: |
DRUG: Calcifediol Oral Capsule|DRUG: Calcifediol Oral Product|DRUG: Cholecalciferol|DRUG: Paricalcitol Oral Capsule
|
| Outcome Measures: |
Primary: Incidence and Severity of Treatment-Emergent Adverse Events (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0., This study is descriptive and no primary or secondary efficacy endpoints are defined., 5 months |
|
| Sponsor/Collaborators: |
Sponsor: OPKO Health, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
69
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2018-06-08
|
| Completion Date: |
2020-04-24
|
| Results First Posted: |
2022-12-09
|
| Last Update Posted: |
2022-12-09
|
| Locations: |
National Institute of Clinical Research, Inc., Garden Grove, California, 92844, United States|Research by Design, LLC, Chicago, Illinois, 60643, United States|Spaulding Clinical Research, West Bend, Wisconsin, 53095, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03588884
|
