Clinical trial
A Phase 2, Multicenter, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
NCT01225211 is registered in ClinicalTrials.gov with Vertex Pharmaceuticals Incorporated as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- A Phase 2, Multicenter, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Phase
- Phase 2
- Overall status
- Completed
- Start date
- October 31, 2010
- Completion date
- April 30, 2014
- Enrollment
- 312 (actual)
- Sites
- 55
Conditions
As the registry lists them; a condition with its own page is linked.