A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension.

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02759419
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bayer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bayer Study Director
Principal Investigator Affiliation Bayer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries France, Italy, Korea, Republic of, Poland, Thailand
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hypertension, Pulmonary
Arms & Interventions

Arms

Experimental: BAY63-2521

Single-arm, uncontrolled

Interventions

Drug: - Adempas (Riociguat, BAY63-2521)

0.5 to 2.5 mg in 0.5 mg increments (according to individual adapted optimal dose determined in originating study) administered three times daily (tid)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Besancon, France

Status

Completed

Address

Besancon, , 25030

Brest, France

Status

Completed

Address

Brest, , F-29609

Le Kremlin Bicetre Cedex, France

Status

Completed

Address

Le Kremlin Bicetre Cedex, , 94275

Lille Cedex, France

Status

Completed

Address

Lille Cedex, , 59037

Rouen, France

Status

Completed

Address

Rouen, , 76031

Roma, Lazio, Italy

Status

Withdrawn

Address

Roma, Lazio, 00161

Pavia, Lombardia, Italy

Status

Withdrawn

Address

Pavia, Lombardia, 27100

Seoul, Seoul Teugbyeolsi, Korea, Republic of

Status

Recruiting

Address

Seoul, Seoul Teugbyeolsi, 03080

Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul, , 03722

Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul, , 05505

Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul, , 06351

Krakow, Poland

Status

Withdrawn

Address

Krakow, , 31-202

Lodz, Poland

Status

Withdrawn

Address

Lodz, , 91-347

Otwock, Poland

Status

Withdrawn

Address

Otwock, , 05-400

Wroclaw, Poland

Status

Withdrawn

Address

Wroclaw, , 51-124

Bangkok, Thailand

Status

Withdrawn

Address

Bangkok, , 10330

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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