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NCT03588884 · ClinicalTrials.gov registry record · Phase 4
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
A Phase 4 study, sponsored by OPKO Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 69
- Enrollment target
NCT03588884: Completed Phase 4 study, sponsored by OPKO Health.
NCT03588884 is a Phase 4 study that has completed, run by OPKO Health. The registered enrollment target is 69 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03588884, a Phase 4 study, has completed, sponsored by OPKO Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 69 participants
- Enrollment target
Study Summary
An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency
Primary Outcome
This study is descriptive and no primary or secondary efficacy endpoints are defined.
Interventions
- DRUG Cholecalciferol
- DRUG Calcifediol Oral Capsule
- DRUG Calcifediol Oral Product
- DRUG Paricalcitol Oral Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2018-06-08 |
| Est. Completion | 2020-04-24 |
| Phase | Phase 4 |
What the finished NCT03588884 record still lists
NCT03588884 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 4 interventions - of which Cholecalciferol is the first listed.
NCT03588884 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03588884 about?
NCT03588884 is a clinical study titled "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". An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidne...
What is the current status of trial NCT03588884?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 69 participants. The study started on 2018-06-08. Estimated completion is 2020-04-24.
What interventions are being tested in trial NCT03588884?
The interventions under investigation include: Cholecalciferol (DRUG), Calcifediol Oral Capsule (DRUG), Calcifediol Oral Product (DRUG), Paricalcitol Oral Capsule (DRUG).
Who is sponsoring clinical trial NCT03588884?
This trial is sponsored by OPKO Health, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03588884's enrollment target sits among peer trials
69 1070th of 2000 higher than 925 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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