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
Phase of Trial: Phase IV
Latest Information Update: 24 Sep 2019
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At a glance
- Drugs Calcifediol (Primary) ; Colecalciferol; Paricalcitol
- Indications Secondary hyperparathyroidism
- Focus Adverse reactions
- Sponsors OPKO Renal
- 31 May 2019 Planned End Date changed from 4 Aug 2019 to 22 May 2020.
- 31 May 2019 Planned primary completion date changed from 4 Jun 2019 to 17 Mar 2020.
- 18 Jan 2019 Planned End Date changed from 4 Dec 2018 to 4 Aug 2019.