Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Brief Summary: The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.


Options:
A: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: 150 mg Ivacaftor q12h; Type: EXPERIMENTAL; Interventions: Drug: Ivacaftor | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): 150 mg Ivacaftor q12h | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: LUM 600 mg qd/IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination, Drug: Ivacaftor | Arm Label: LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Lumacaftor Plus Ivacaftor Combination; Assigned to Arm(s): LUM 400 mg q12h/ IVA 250 mg q12h, LUM 600 mg qd/IVA 250 mg q12h | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): LUM 600 mg qd/IVA 250 mg q12h
C: Arm Label: Part A: VX-659 or Matching Placebo; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: VX-659 Matching Placebo | Arm Label: Part B: VX-659 or Matching Placebo; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: VX-659 Matching Placebo | Arm Label: Part C: VX-659 in TC with TEZ/IVA or Matching Triple Placebo; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: Tezacaftor, Drug: Ivacaftor, Drug: Triple Combination (TC) Matching Placebos | Arm Label: Part D: VX-659 in TC with TEZ/IVA or Matching Triple Placebo; Type: EXPERIMENTAL; Interventions: Drug: VX-659, Drug: Tezacaftor, Drug: Ivacaftor, Drug: Triple Combination (TC) Matching Placebos | Intervention Type: DRUG; Name: VX-659; Assigned to Arm(s): Part A: VX-659 or Matching Placebo, Part B: VX-659 or Matching Placebo, Part C: VX-659 in TC with TEZ/IVA or Matching Triple Placebo, Part D: VX-659 in TC with TEZ/IVA or Matching Triple Placebo | Intervention Type: DRUG; Name: Tezacaftor; Assigned to Arm(s): Part C: VX-659 in TC with TEZ/IVA or Matching Triple Placebo, Part D: VX-659 in TC with TEZ/IVA or Matching Triple Placebo | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): Part C: VX-659 in TC with TEZ/IVA or Matching Triple Placebo, Part D: VX-659 in TC with TEZ/IVA or Matching Triple Placebo | Intervention Type: DRUG; Name: VX-659 Matching Placebo; Assigned to Arm(s): Part A: VX-659 or Matching Placebo, Part B: VX-659 or Matching Placebo | Intervention Type: DRUG; Name: Triple Combination (TC) Matching Placebos; Assigned to Arm(s): Part C: VX-659 in TC with TEZ/IVA or Matching Triple Placebo, Part D: VX-659 in TC with TEZ/IVA or Matching Triple Placebo
D: Arm Label: VX-661/IVA; Type: EXPERIMENTAL; Interventions: Drug: VX-661 plus ivacaftor combination, Drug: Ivacaftor | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo (matched to VX-661 plus ivacaftor combination), Drug: Placebo (matched to ivacaftor) | Intervention Type: DRUG; Name: VX-661 plus ivacaftor combination; Assigned to Arm(s): VX-661/IVA | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): VX-661/IVA | Intervention Type: DRUG; Name: Placebo (matched to VX-661 plus ivacaftor combination); Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Placebo (matched to ivacaftor); Assigned to Arm(s): Placebo

Answer: B