Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Johnson and Johnson
Moodys
AstraZeneca
Baxter

Last Updated: December 13, 2019

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR IVACAFTOR; LUMACAFTOR

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

All Clinical Trials for ivacaftor; lumacaftor

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01225211 Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation Completed Vertex Pharmaceuticals Incorporated Phase 2 2010-10-01 The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with ivacaftor (VX-770) in participants with cystic fibrosis, homozygous or heterozygous for the F508del-CFTR mutation.
NCT01768663 A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects Completed Vertex Pharmaceuticals Incorporated Phase 1 2013-01-01 The purpose of this study is to examine the drug-drug interaction effects of ciprofloxacin, itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with ivacaftor as well as to evaluate the potential effects of lumacaftor in combination with ivacaftor on lung function.
NCT01807923 A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation Completed Vertex Pharmaceuticals Incorporated Phase 3 2013-05-01 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.
NCT01807949 A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation Completed Vertex Pharmaceuticals Incorporated Phase 3 2013-04-01 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.
NCT01888393 Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects Completed Vertex Pharmaceuticals Incorporated Phase 1 2013-06-01 This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment.
NCT01897233 Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation Completed Vertex Pharmaceuticals Incorporated Phase 3 2013-07-01 This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study to evaluate the pharmacokinetics, safety, and tolerability of lumacaftor in combination with ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the F508del-mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ivacaftor; lumacaftor

Condition Name

Condition Name for ivacaftor; lumacaftor
Intervention Trials
Cystic Fibrosis 28
Diabetes 2
Cystic Fibrosis, Homozygous for the F508del CFTR Mutation 2
Homozygous F508del Mutation 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Condition MeSH

Condition MeSH for ivacaftor; lumacaftor
Intervention Trials
Cystic Fibrosis 31
Fibrosis 24
Lung Diseases 2
Liver Diseases 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Locations for ivacaftor; lumacaftor

Trials by Country

Trials by Country for ivacaftor; lumacaftor
Location Trials
United States 284
Canada 23
France 22
United Kingdom 19
Germany 17
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Trials by US State

Trials by US State for ivacaftor; lumacaftor
Location Trials
Missouri 13
Massachusetts 12
California 12
Colorado 11
Pennsylvania 11
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Progress for ivacaftor; lumacaftor

Clinical Trial Phase

Clinical Trial Phase for ivacaftor; lumacaftor
Clinical Trial Phase Trials
Phase 4 3
Phase 3 11
Phase 2 5
[disabled in preview] 11
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Status

Clinical Trial Status for ivacaftor; lumacaftor
Clinical Trial Phase Trials
Completed 13
Recruiting 9
Not yet recruiting 6
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Sponsors for ivacaftor; lumacaftor

Sponsor Name

Sponsor Name for ivacaftor; lumacaftor
Sponsor Trials
Vertex Pharmaceuticals Incorporated 20
National Heart, Lung, and Blood Institute (NHLBI) 2
Nivalis Therapeutics, Inc. 2
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Sponsor Type

Sponsor Type for ivacaftor; lumacaftor
Sponsor Trials
Industry 23
Other 13
NIH 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Dow
AstraZeneca
Express Scripts
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.