Early Signs of Efficacy Study With Riociguat in Adult Homozygous Delta F508 Cystic Fibrosis Patients

PHASE2TerminatedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

January 17, 2017

Study Completion Date

September 22, 2017

Conditions
Cystic Fibrosis
Interventions
DRUG

Riociguat (Adempas, BAY63-2521)

Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient.

DRUG

Placebo

Participants received matching placebo tid.

Trial Locations (10)

1090

Bruxelles - Brussel

13353

Berlin

63110

St Louis

75674

Paris

80206

Denver

35233-1711

Birmingham

M5B 1W8

Toronto

3015 CE

Rotterdam

BT12 7AB

Belfast

SW3 6NP

London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Bayer

INDUSTRY