AzTrials
AzTrials

Hypertension, PulmonaryPhase 3PATENT-2NCT00863681

BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension

A Phase 3 study testing Riociguat (BAY63-2521) in people with Hypertension, Pulmonary, run by Bayer at 99 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hypertension, Pulmonary
What is being tested?
Riociguat (BAY63-2521)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
396 participants
Where
99 sitesin 27 countries
Study dates
12 Mar 2009to 19 Aug 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who have completed 12 weeks of treatment in the double blind trial PATENT 1

Who cannot join

  • Patients who have an ongoing serious adverse event from PATENT 1 that is assessed as related to BAY63-2521 are not allowed to participate in the extension trial.

Trial locations and contacts

99 sites in 27 countries.

99 sites in 27 countries

Japan13 sites

  • Study site

    Bunkyo-ku, Tokyo, 113-8655

  • Study site

    Hiroshima, 734-8551

  • Study site

    Kanazawa, Ishikawa-ken, 920-8641

  • Study site

    Kobe, Hyōgo, 650-0017

  • Study site

    Mitaka, Tokyo, 181-8611

  • Study site

    Nagoya, Aichi-ken, 467-8602

  • Study site

    Okayama, 701-1192

  • Study site

    Ōta-ku, Tokyo, 143-8541

  • Study site

    Sendai, Miyagi, 980-8574

  • Study site

    Shinjuku-ku, Tokyo, 160-8582

  • Study site

    Tomigusuku, Okinawa, 901-0243

  • Study site

    Toride, Ibaraki, 302-0022

  • Study site

    Tsukuba, Ibaraki, 305-8576

Other trials in Japan

United States11 sites

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Boston, Massachusetts, 02111

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Columbus, Ohio, 43221

  • Study site

    Dallas, Texas, 75390-9252

  • Study site

    El Paso, Texas, 79902

  • Study site

    Fairfield, Ohio, 45014

  • Study site

    Los Angeles, California, 90073

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Sacramento, California, 95817

Other trials in United States

Germany9 sites

  • Study site

    Cologne, North Rhine-Westphalia, 50924

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Giessen, Hesse, 35392

  • Study site

    Greifswald, Mecklenburg-Vorpommern, 17475

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Heidelberg, Baden-Wurttemberg, 69126

  • Study site

    Homburg, Saarland, 66421

  • Study site

    Leipzig, Saxony, 04103

  • Study site

    München, Bavaria, 81377

Other trials in Germany

France7 sites

  • Study site

    Besançon, 25030

  • Study site

    Brest, F-29609

  • Study site

    Grenoble, 38043

  • Study site

    Lille, 59037

  • Study site

    Montpellier, 34059

  • Study site

    Pessac, 33604

  • Study site

    Rouen, 76031

Other trials in France

Mexico6 sites

  • Study site

    Culiacán, Sinaloa, 80020

  • Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

    Guadalajara, Jalisco, 44280

  • Pulmocritic

    Guadalajara, Jalisco, 44670

  • Study site

    Mexico City, 14080

  • Study site

    Monterrey, Nuevo León, 64020

  • Study site

    Querétaro, 38000

Other trials in Mexico

Australia5 sites

  • Study site

    Auchenflower, Queensland, 4066

  • Study site

    Darlinghurst, New South Wales, 2010

  • Study site

    Herston, Queensland, 4029

  • Study site

    Hobart, Tasmania, 7000

  • Study site

    Prahran, Victoria, 3181

Other trials in Australia

China5 sites

  • Study site

    Beijing, 100020

  • Study site

    Beijing, 100037

  • Study site

    Guangzhou, Guangdong, 510100

  • Study site

    Shanghai, 200032

  • Study site

    Shanghai, 200433

Other trials in China

Brazil4 sites

  • Study site

    Porto Alegre, Rio Grande do Sul, 90020 090

  • Study site

    Rio de Janeiro, 21941-913

  • Study site

    São Paulo, São Paulo, 04012 180

  • Study site

    São Paulo, São Paulo, 04020-050

Other trials in Brazil

Italy4 sites

  • Study site

    Milan, Lombardy, 20123

  • Study site

    Pavia, Lombardy, 27100

  • Study site

    Rome, Lazio, 00161

  • Study site

    Trieste, Friuli Venezia Giulia, 34149

Other trials in Italy

Austria3 sites

  • Study site

    Innsbruck, 6020

  • Study site

    Linz, Upper Austria, 4020

  • Study site

    Vienna, 1090

Other trials in Austria

Portugal3 sites

  • Study site

    Coimbra, 3000-075

  • Study site

    Lisbon, 1169-024

  • Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

    Lisbon, 1649-035

Other trials in Portugal

South Korea3 sites

  • Study site

    Seoul, 03722

  • Study site

    Seoul, 05505

  • Study site

    Seoul, 06351

Other trials in South Korea

Taiwan3 sites

  • Study site

    Kaohsiung City, 813414

  • Study site

    Taipei, 100

  • Study site

    Taipei, 11217

Other trials in Taiwan

Turkey (Türkiye)3 sites

  • Study site

    Ankara

  • Study site

    Istanbul, 34098

  • Study site

    Izmir, 35-100

Other trials in Turkey (Türkiye)

United Kingdom3 sites

  • Study site

    Cambridge, Cambridgeshire, CB23 3RE

  • Study site

    Clydebank, West Dunbartonshire, G81 4DY

  • Study site

    London, NW3 2QG

Other trials in United Kingdom

Belgium2 sites

  • Study site

    Bruxelles - Brussel, 1070

  • Study site

    Leuven, 3000

Other trials in Belgium

Canada2 sites

  • Study site

    Calgary, Alberta, T1Y 6J4

  • Study site

    Montreal, Quebec, H3T 1E2

Other trials in Canada

Russia2 sites

  • Study site

    Moscow, 121552

  • Study site

    Saint Petersburg, 197341

Other trials in Russia

Singapore2 sites

  • Study site

    Singapore, 119228

  • Study site

    Singapore, 168752

Other trials in Singapore

Thailand2 sites

  • Study site

    Bangkok, 10330

  • Study site

    Chiang Mai, 50200

Other trials in Thailand

Argentina1 site

  • Study site

    Capital Federal

Other trials in Argentina

Czechia1 site

  • Study site

    Prague, 12808

Other trials in Czechia

Denmark1 site

  • Study site

    Aarhus N, 8200

Other trials in Denmark

Greece1 site

  • Study site

    Chaïdári, 124 62

Other trials in Greece

Poland1 site

  • Study site

    Otwock, 05-400

Other trials in Poland

Sweden1 site

  • Study site

    Umeå, 901 85

Other trials in Sweden

Switzerland1 site

  • Study site

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: Long-term Extension, Multicentre, Multi-national Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg,1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)

Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521.

Being tested
Riociguat (BAY63-2521)
Keywords
Pulmonary arterial hypertension, PH, Stimulator
Medical subject headings
Hypertension, Pulmonary, Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Riociguat (BAY63-2521)Drug

    BAY63-2521: 1mg tid -2.5 mg tid oral until end of study

Study groups in NCT00863681
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Riociguat (BAY63-2521)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-emergent Adverse Events (TEAE)

    Analyses of drug-related TEAEs were based on the assessment of causal relationship to study medication.

    Measured: From administration of first dose of study medication in PATENT-2 up to 2 days after end of treatment with study medication, up to 10 years and 5 months.

  2. Number of Participant With Death

    Analyses of deaths were based on the assessment of causal relationship to study medication. The safety follow-up visit was to be performed 30 days after the last dose of riociguat.

    Measured: From baseline to end of safety follow-up visit, up to 10 years and 6 months (1 month more than End of study visit)

Secondary outcomes (4)

  1. Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Hematology and Coagulation

    Percentage of participants only with a treatment-emergent shift in hematology and coagulation parameters from normal or low at baseline to a high value at a timepoint after the start of treatment. The percentage was calculated by comparing the number of participants with a normal or low value at baseline who had at least one high value after the start of treatment with the number of participants with a normal or low value at baseline who also had at least one valid value after start of treatment.

    A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.

    Measured: From baseline to termination visit, up to 10 years

  2. Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Hematology and Coagulation

    Percentage of participants only with a treatment-emergent shift in hematology and coagulation parameters from normal or high at baseline to a low value at a timepoint after the start of treatment. The percentage was calculated by comparing the number of participants with a normal or high value at baseline who had at least one low value after the start of treatment with the number of participants with a normal or high value at baseline who also had at least one valid value after start of treatment.

    A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.

    Measured: From baseline to termination visit, up to 10 years

  3. Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Clinical Chemistry

    Percentage of participants per treatment group only with a treatment-emergent shift in clinical chemistry parameters from normal or low at baseline to a high value at a timepoint after the start of treatment. The percentage was calculated by comparing the number of participants with a normal or low value at baseline who had at least one high value after the start of treatment with the number of participants with a normal or low value at baseline who also had at least one valid value after start of treatment.

    A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.

    Measured: From baseline to termination visit, up to 10 years

  4. Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Clinical Chemistry

    Percentage of participants per treatment group only with a treatment-emergent shift in clinical chemistry parameters from normal or high at baseline to a low value at a timepoint after the start of treatment. The percentage was calculated by comparing the number of participants with a normal or high value at baseline who had at least one low value after the start of treatment with the number of participants with a normal or high value at baseline who also had at least one valid value after start of treatment.

    A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.

    Measured: From baseline to termination visit, up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2009 (estimated)
  2. Study start12 Mar 2009
  3. Primary completion19 Aug 2019
  4. Study completion19 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
396 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00863681
Sponsor's protocol ID
12935
Other IDs
2008-003610-94, 2008
Acronym
PATENT-2
Status last verified
Nov 2023
First submitted
13 Mar 2009
Last updated
7 Nov 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Benza RL, Boucly A, Farber HW, Frost AE, Ghofrani HA, Hoeper MM, Lambelet M, Rahner C, Bansilal S, Nikkho S, Meier C, Sitbon O. Change in REVEAL Lite 2 risk score predicts outcomes in patients with pulmonary arterial hypertension in the PATENT study. J Heart Lung Transplant. 2022 Mar;41(3):411-420. doi: 10.1016/j.healun.2021.10.013. Epub 2021 Oct 28.

    PubMed 34848133

  • Benza RL, Farber HW, Frost AE, Ghofrani HA, Corris PA, Lambelet M, Nikkho S, Meier C, Hoeper MM. Application of the REVEAL risk score calculator 2.0 in the CHEST study. Respir Med. 2022 Apr-May;195:106783. doi: 10.1016/j.rmed.2022.106783. Epub 2022 Mar 1.

    PubMed 35256218

  • Ghofrani HA, Grimminger F, Grunig E, Huang Y, Jansa P, Jing ZC, Kilpatrick D, Langleben D, Rosenkranz S, Menezes F, Fritsch A, Nikkho S, Humbert M. Predictors of long-term outcomes in patients treated with riociguat for pulmonary arterial hypertension: data from the PATENT-2 open-label, randomised, long-term extension trial. Lancet Respir Med. 2016 May;4(5):361-71. doi: 10.1016/S2213-2600(16)30019-4. Epub 2016 Apr 8.

    PubMed 27067479

  • Ghofrani HA, Humbert M, Langleben D, Schermuly R, Stasch JP, Wilkins MR, Klinger JR. Riociguat: Mode of Action and Clinical Development in Pulmonary Hypertension. Chest. 2017 Feb;151(2):468-480. doi: 10.1016/j.chest.2016.05.024. Epub 2016 Jun 2.

    PubMed 27263466

  • Benza RL, Ghofrani HA, Grunig E, Hoeper MM, Jansa P, Jing ZC, Kim NH, Langleben D, Simonneau G, Wang C, Busse D, Meier C, Ghio S. Effect of riociguat on right ventricular function in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. J Heart Lung Transplant. 2021 Oct;40(10):1172-1180. doi: 10.1016/j.healun.2021.06.020. Epub 2021 Jul 10.

    PubMed 34353714

  • Humbert M, Coghlan JG, Ghofrani HA, Grimminger F, He JG, Riemekasten G, Vizza CD, Boeckenhoff A, Meier C, de Oliveira Pena J, Denton CP. Riociguat for the treatment of pulmonary arterial hypertension associated with connective tissue disease: results from PATENT-1 and PATENT-2. Ann Rheum Dis. 2017 Feb;76(2):422-426. doi: 10.1136/annrheumdis-2015-209087. Epub 2016 Jul 25.

    PubMed 27457511

  • Saleh S, Becker C, Frey R, Muck W. Population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of riociguat in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulm Circ. 2016 Mar;6(Suppl 1):S86-96. doi: 10.1086/685404.

    PubMed 27162632

  • Rosenkranz S, Ghofrani HA, Beghetti M, Ivy D, Frey R, Fritsch A, Weimann G, Saleh S, Apitz C. Riociguat for pulmonary arterial hypertension associated with congenital heart disease. Heart. 2015 Nov;101(22):1792-9. doi: 10.1136/heartjnl-2015-307832. Epub 2015 Jul 1.

    PubMed 26135803

  • Rubin LJ, Galie N, Grimminger F, Grunig E, Humbert M, Jing ZC, Keogh A, Langleben D, Fritsch A, Menezes F, Davie N, Ghofrani HA. Riociguat for the treatment of pulmonary arterial hypertension: a long-term extension study (PATENT-2). Eur Respir J. 2015 May;45(5):1303-13. doi: 10.1183/09031936.00090614. Epub 2015 Jan 22.

    PubMed 25614164

  • Ghofrani HA, Galie N, Grimminger F, Grunig E, Humbert M, Jing ZC, Keogh AM, Langleben D, Kilama MO, Fritsch A, Neuser D, Rubin LJ; PATENT-1 Study Group. Riociguat for the treatment of pulmonary arterial hypertension. N Engl J Med. 2013 Jul 25;369(4):330-40. doi: 10.1056/NEJMoa1209655.

    PubMed 23883378

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Riociguat (BAY63-2521) in people with Hypertension, Pulmonary, run by Bayer at 99 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in Japan, United States, Germany, France, Mexico and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-emergent Adverse Events (TEAE) (time frame: From administration of first dose of study medication in PATENT-2 up to 2 days after end of treatment with study medication, up to 10 years and 5 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00863681, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in