stop_circleTerminated/Withdrawn

Cystic fibrosis

Early signs of efficacy study with Riociguat in adult homozygous delta F508 Cystic Fibrosis patients

Trial purpose

Assessment of the safety, tolerability and early signs of efficacy of three times a day orally administered BAY63-2521 in adult delta F508 homozygous Cystic Fibrosis patients not on treatment with Orkambi

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
21
Trial Dates
September 2014 - September 2017
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Toronto, M5B 1W8, Canada
Terminated
Berlin, 13353, Germany
Terminated
London, SW3 6NP, United Kingdom
Terminated
Belfast, BT12 7AB, United Kingdom
Completed
Birmingham, 35233-1711, United States
Withdrawn
Cincinnati, 45229, United States
Withdrawn
Iowa City, 52242-1089, United States
Completed
Saint Louis, 63110, United States
Completed
Denver, 80206, United States
Terminated
PARIS, 75674, France
Terminated
ROTTERDAM, 3015 CE, Netherlands
Withdrawn
PARIS, 75015, France
Withdrawn
Verona, 37126, Italy
Terminated
BRUXELLES - BRUSSEL, 1090, Belgium
Withdrawn
Boston, 2115, United States
Withdrawn
Dresden, 01307, Germany
Withdrawn
Essen, 45239, Germany
Withdrawn
Hannover, 30625, Germany
Withdrawn
Chicago, 60611, United States
Withdrawn
Falls Church, 22042-3300, United States
Withdrawn
Thessaloniki, 54642, Greece
Withdrawn
Quebec City, G1V 4G5, Canada
Withdrawn
EDEGEM, 2650, Belgium

Primary Outcome

  • Change of sweat chloride content from baseline
    Sweat chloride samples were obtained by using a Macroduct induction and collection device according to standard procedures.
    date_rangeTime Frame:
    Baseline, at day 14 and day 28 in study part 1

Trial design

Multi-center phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult delta F508 homozygous Cystic Fibrosis patients
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2