drugset / Trial / NCT01651000

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

NCT01651000

Phase 3 Completed 213 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
2012-09
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Calcifediol Unknown 30 ug