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: Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination, Drug: Ivacaftor | Arm Label: Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination, Drug: Ivacaftor | Arm Label: Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Arm Label: Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Arm Label: Arm 5 Part A: Observational Cohort; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Arm Label: Arm 7 Part B: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Intervention Type: DRUG; Name: Lumacaftor Plus Ivacaftor Combination; Assigned to Arm(s): Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h, Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h, Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h, Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h, Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h, Arm 7 Part B: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h, Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: miglustat | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: miglustat; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 2
C: Arm Label: ELX/TEZ/IVA; Type: EXPERIMENTAL; Interventions: Drug: ELX/TEZ/IVA, Drug: IVA | Intervention Type: DRUG; Name: ELX/TEZ/IVA; Assigned to Arm(s): ELX/TEZ/IVA | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): ELX/TEZ/IVA
D: 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

Answer: D