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Drug & research development » Clinical trials » NCT00909532

Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older With the G551D Mutation (STRIVE)

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-770 in Subjects With Cystic Fibrosis and the G551D Mutation

Clinical Trials gov number: NCT00909532

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Purpose: To evaluate the efficacy and safety of ivacaftor in CF patients aged ≥12 years who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Phase: 3

Type: Interventional, randomized, double-blind, parallel assignment

Study sponsor: Vertex Pharmaceuticals Incorporated; Cystic Fibrosis Foundation Therapeutics

  • Confirmed diagnosis of CF and G551D mutation in ≥1 allele
  • Forced expiratory volume in 1 second (FEV1) of 40–90% (inclusive) of predicted normal for age, gender, and height at screening
  • No clinically significant abnormalities that would have interfered with the study assessments, as judged by the investigator
  • Willing to use highly effective birth control methods during the study

Intervention
Ivacaftor

Geographical Location
Australia, Canada, Czech Republic, France, Germany, Ireland, United Kingdom, United States

Number of Participants
101-1000 (≥12 years)

Primary Endpoint

Absolute mean change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) through Week 24

Secondary Endpoint

  • Absolute mean change from baseline (BL) in percent predicted FEV1 through Week 48
  • Absolute change from BL in Cystic Fibrosis Questionnaire-Revised score through Week 24 and Week 48 (Respiratory Domain Score, Pooled)
  • Absolute change from BL in sweat chloride concentration through Week 24 and Week 48
  • Time-to-first pulmonary exacerbation through Week 24 and Week 48
  • Absolute change from BL in weight through Week 24 and Week 48

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  • Placebo Comparator:

     Subjects who received placebo every 12 hours (q12h) for up to 48 weeks.

  • Experimental:

     Subjects who received 150 mg of ivacaftor q12h for up to 48 weeks.

Link:

http://www.ncbi.nlm.nih.gov/pubmed/24461666

Reference:

Ramsey BW, Davies J, McElvaney NG, Tullis E, Bell SC, Dřevínek P, Griese M, McKone EF, Wainwright CE, Konstan MW, Moss R, Ratjen F, Sermet-Gaudelus I, Rowe SM, Dong Q, Rodriguez S, Yen K, Ordoñez C, Elborn JS; VX08-770-102 Study Group. A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. N Engl  J Med. 2011 Nov 3;365(18):1663-72. doi: 10.1056/NEJMoa1105185. PubMed PMID: 22047557; PubMed Central PMCID: PMC3230303.

View Trial Results