Recruitment Complete

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

Inclusion Criteria
- 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.
Exclusion Criteria
- 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

Trial Dates

June 2016 - September 2025

Phase

Phase 4

Could I Receive a placebo

Products

Adempas (Riociguat, BAY63-2521)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
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Withdrawn		Roma, 00161, Italy
Withdrawn		Pavia, 27100, Italy
Active, not recruiting		Seoul, 03722, Korea,_republic_of
Active, not recruiting		Seoul, 3080, Korea,_republic_of
Withdrawn		Bangkok, 10330, Thailand
Active, not recruiting		Seoul, 06351, Korea,_republic_of
Completed		Seoul, 05505, 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
Time Frame:
Up to approx. 3 years
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

Additional Information

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