drugset / Trial / NCT01704079

Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency

NCT01704079

Phase 3 Completed 216 enrolled OPKO IP Holdings II, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated

Timeline

Start
2012-11
Primary completion
2014-08
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Calcifediol Unknown 30 ug
Comparator Calcifediol Unknown 60 ug