account_circleRecruiting

Hypertension, Pulmonary

Bayer Identifier:

18694

ClinicalTrials.gov Identifier:

NCT02759419

EudraCT Number:

2016-000501-36

EU CT Number:

Not Available
A long-term extension study of riociguat in patients with symptomatic pulmonary arterial hypertension.

Trial purpose

To provide riociguat therapy to eligible patients with PAH originating from Bayer-sponsored trials with BAY63-2521/ Riociguat / Adempas® who are currently or recently treated in these trials until lack of patient benefit as assessed by investigator, or commercial availability and reimbursement.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Patients diagnosed with Pulmonary Arterial Hypertension (PAH) participating or having participated in the Bayer-sponsored studies 12935, 16719 or 18588, who have completed the main study phase and are still being treated with riociguat (either while still being on treatment with the respective study drug or by commercial means with Adempas) and who, in the opinion of the investigator, are expected to continue to have an overall positive benefit/risk from continuing treatment.
    - Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and 30 days after the last administration of study drug.
  • - Ongoing serious adverse event (SAE) from originating study that is assessed as related to riociguat
    - Pregnant women or breast-feeding women
    - Any contra-indication to Adempas treatment listed in the BAY63-2521 / Riociguat Investigators's Brochure
    - Concomitant participation in another clinical study with the study drug
    - Patients with pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP)

Trial summary

Enrollment Goal
25
Trial Dates
June 2016 - December 2025
Phase
Phase 4
Could I Receive a placebo
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Lille Cedex, 59037, France
Completed
BREST, F-29609, France
Completed
Rouen, 76031, France
Completed
BESANCON, 25030, France
Completed
LE KREMLIN-BICETRE, 94275, France
Withdrawn
Roma, 00161, Italy
Withdrawn
Pavia, 27100, Italy
Recruiting
Seoul, 03722, Korea,_republic_of
Active, not recruiting
Seoul, 3080, Korea,_republic_of
Withdrawn
Bangkok, 10330, Thailand
Recruiting
Seoul, 6351, Korea,_republic_of
Completed
Seoul, 138-736, Korea,_republic_of
Withdrawn
Otwock, 05-400, Poland
Withdrawn
Lodz, 91-347, Poland
Withdrawn
Krakow, 31-202, Poland
Withdrawn
Wroclaw, 51-124, Poland

Primary Outcome

  • Number of patients with treatment-emergent adverse events (TEAEs) as measure of safety and tolerability
    date_rangeTime Frame:
    Up to approx. 3 years
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

An open-label, multi-national, multi-center, single-arm, uncontrolled, long-term extension study of orally administered riociguat in patients with symptomatic pulmonary arterial hypertension (PAH) who received riociguat in a Bayer clinical trial
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

Click here to find further information and, after study completion, the study results according to Bayer's transparency standards