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

NCT00863681 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 129352008-003610-94
• Study Type: interventional
• Target: 396
• Locations: 26 countries
• Sites: 96

Brief 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.

Conditions

Hypertension, Pulmonary

Keywords

Pulmonary arterial hypertension; PH; Stimulator

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

• 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.

  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)

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

  From baseline to termination visit, up to 10 years

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

  From baseline to termination visit, up to 10 years

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

  From baseline to termination visit, up to 10 years

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

  From baseline to termination visit, up to 10 years

Other Outcomes (20)

• Change of Systolic Blood Pressure (SBP)

  From baseline to termination visit, up to 10 years

• Change of Diastolic Blood Pressure (DBP)

  From baseline to termination visit, up to 10 years

• Change of Heart Rate

  From baseline to termination visit, up to 10 years

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Riociguat (BAY63-2521)

Interventions

Riociguat (BAY63-2521) DRUG

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

Arm 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (99)

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Los Angeles, California, 90073, United States

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Sacramento, California, 95817, United States

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Aurora, Colorado, 80045, United States

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Boston, Massachusetts, 02111, United States

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Boston, Massachusetts, 02114, United States

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Omaha, Nebraska, 68131, United States

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Cleveland, Ohio, 44195, United States

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Columbus, Ohio, 43221, United States

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Fairfield, Ohio, 45014, United States

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Dallas, Texas, 75390-9252, United States

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El Paso, Texas, 79902, United States

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Capital Federal, Argentina

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Darlinghurst, New South Wales, 2010, Australia

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Auchenflower, Queensland, 4066, Australia

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Herston, Queensland, 4029, Australia

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Hobart, Tasmania, 7000, Australia

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Prahran, Victoria, 3181, Australia

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Linz, Upper Austria, 4020, Austria

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Innsbruck, 6020, Austria

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Vienna, 1090, Austria

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Bruxelles - Brussel, 1070, Belgium

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Leuven, 3000, Belgium

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Porto Alegre, Rio Grande do Sul, 90020 090, Brazil

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São Paulo, São Paulo, 04012 180, Brazil

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São Paulo, São Paulo, 04020-050, Brazil

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Rio de Janeiro, 21941-913, Brazil

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Calgary, Alberta, T1Y 6J4, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Guangzhou, Guangdong, 510100, China

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Beijing, 100020, China

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Beijing, 100037, China

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Shanghai, 200032, China

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Shanghai, 200433, China

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Prague, 12808, Czechia

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Aarhus N, 8200, Denmark

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Besançon, 25030, France

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Brest, F-29609, France

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Grenoble, 38043, France

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Lille, 59037, France

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Montpellier, 34059, France

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Pessac, 33604, France

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Rouen, 76031, France

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Heidelberg, Baden-Wurttemberg, 69126, Germany

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München, Bavaria, 81377, Germany

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Giessen, Hesse, 35392, Germany

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Hanover, Lower Saxony, 30625, Germany

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Greifswald, Mecklenburg-Vorpommern, 17475, Germany

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Cologne, North Rhine-Westphalia, 50924, Germany

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Homburg, Saarland, 66421, Germany

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Dresden, Saxony, 01307, Germany

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Leipzig, Saxony, 04103, Germany

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Chaïdári, 124 62, Greece

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Trieste, Friuli Venezia Giulia, 34149, Italy

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Rome, Lazio, 00161, Italy

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Milan, Lombardy, 20123, Italy

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Pavia, Lombardy, 27100, Italy

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Nagoya, Aichi-ken, 467-8602, Japan

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Kobe, Hyōgo, 650-0017, Japan

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Toride, Ibaraki, 302-0022, Japan

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Tsukuba, Ibaraki, 305-8576, Japan

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Kanazawa, Ishikawa-ken, 920-8641, Japan

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Sendai, Miyagi, 980-8574, Japan

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Tomigusuku, Okinawa, 901-0243, Japan

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Bunkyo-ku, Tokyo, 113-8655, Japan

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Mitaka, Tokyo, 181-8611, Japan

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Ōta-ku, Tokyo, 143-8541, Japan

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Shinjuku-ku, Tokyo, 160-8582, Japan

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Hiroshima, 734-8551, Japan

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Okayama, 701-1192, Japan

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Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco, 44280, Mexico

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Pulmocritic

Guadalajara, Jalisco, 44670, Mexico

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Monterrey, Nuevo León, 64020, Mexico

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Culiacán, Sinaloa, 80020, Mexico

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Mexico City, 14080, Mexico

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Querétaro, 38000, Mexico

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Otwock, 05-400, Poland

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Coimbra, 3000-075, Portugal

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Lisbon, 1169-024, Portugal

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Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

Lisbon, 1649-035, Portugal

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Moscow, 121552, Russia

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Saint Petersburg, 197341, Russia

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Singapore, 119228, Singapore

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Singapore, 168752, Singapore

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Seoul, 03722, South Korea

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Seoul, 05505, South Korea

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Seoul, 06351, South Korea

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Umeå, 901 85, Sweden

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Zurich, 8091, Switzerland

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Kaohsiung City, 813414, Taiwan

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Taipei, 100, Taiwan

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Taipei, 11217, Taiwan

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Bangkok, 10330, Thailand

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Chiang Mai, 50200, Thailand

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Ankara, Turkey (Türkiye)

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Istanbul, 34098, Turkey (Türkiye)

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Izmir, 35-100, Turkey (Türkiye)

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Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

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Clydebank, West Dunbartonshire, G81 4DY, United Kingdom

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London, NW3 2QG, United Kingdom

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Related Publications (10)

• 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.

  PMID: 34848133 BACKGROUND

• 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.

  PMID: 35256218 BACKGROUND

• 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.

  PMID: 27067479 RESULT

• 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.

  PMID: 27263466 RESULT

• 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.

  PMID: 34353714 DERIVED

• 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.

  PMID: 27457511 DERIVED

• 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.

  PMID: 27162632 DERIVED

• 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.

  PMID: 26135803 DERIVED

• 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.

  PMID: 25614164 DERIVED

• 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.

  PMID: 23883378 DERIVED

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MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Interventions

riociguat

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer AG

clinical-trials-contact@bayer.com

(+) 1-888-8422937

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2009
• First Posted: March 18, 2009
• Study Start: March 12, 2009
• Primary Completion: August 19, 2019
• Study Completion: August 19, 2019
• Last Updated: November 7, 2023
• Results First Posted: October 22, 2020

Record last verified: 2023-11

Locations

IT (4); GB (3); AU (5); BE (2); US (11); DE (9); SG (2); KR (3); TW (3); GR (1); FR (7); DK (1); CA (2); AR (1); BR (4); JP (13); PT (3); PL (1); CZ (1); RU (2); SE (1); CH (1); TH (2); CN (5); ME (6); TU (3)