Blood pressure drug riociguat tested for Long-Term use in rare lung condition

NCT ID NCT02759419

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety of the drug riociguat (Adempas) in adults with pulmonary arterial hypertension (PAH), a type of high blood pressure in the lungs. It included 18 people who had already taken riociguat in earlier Bayer studies. The main goal was to track side effects and see if continuing the drug was safe over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

18 people

The number who actually took part.

Started

Jun 2016

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hypertension, pulmonary are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Study site

    Besançon, 25030, France

  • Study site

    Brest, F-29609, France

  • Study site

    Le Kremlin-Bicêtre, 94275, France

  • Study site

    Lille, 59037, France

  • Study site

    Rouen, 76031, France

  • Study site

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

  • Study site

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Study site

    Seoul, Seoul Teugbyeolsi, 3080, South Korea

  • Study site

    Seoul, 06351, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.