BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension

NCT00910429 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 113492008-003539-19
• Study Type: interventional
• Target: 237
• Locations: 25 countries
• Sites: 72

Brief Summary

Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.

Conditions

Pulmonary Hypertension

Keywords

Chronic thromboembolic Hypertension; PH; soluble Guanylate Cyclase Stimulator; sGC

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 up to 2 days after end of treatment with study medication, up to 10 years

• Number of Participants 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 (1 month more than End of study visit)

Secondary Outcomes (6)

• 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

• Change From Baseline of Hemoglobin 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 (Adempas, BAY63-2521)

Interventions

Riociguat (Adempas, BAY63-2521) DRUG

BAY63-2521 - 1 mg tid - 2,5 mg tid orally 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 16 weeks of treatment in the double blind trial CHEST 1

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (73)

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La Jolla, California, 92093, United States

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Sacramento, California, 95817, United States

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Iowa City, Iowa, 52242, United States

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Baltimore, Maryland, 21205, United States

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Boston, Massachusetts, 02118, United States

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Cleveland, Ohio, 44195, United States

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Columbus, Ohio, 43221, United States

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Dallas, Texas, 75390, United States

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Corrientes, 3400, Argentina

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Prahran, Victoria, 3181, Australia

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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, 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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London, Ontario, N6A 4G5, Canada

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Ottawa, Ontario, K1Y 4W7, Canada

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Toronto, Ontario, M5G 2N2, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Beijing, 100020, China

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Beijing, 100037, 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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Brest, F-29609, France

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Le Kremlin-Bicêtre, 94275, France

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Rouen, 76031, France

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Vandœuvre-lès-Nancy, 54511, France

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Heidelberg, Baden-Wurttemberg, 69126, Germany

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München, Bavaria, 81377, Germany

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Würzburg, Bavaria, 97074, Germany

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Giessen, Hesse, 35392, Germany

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Hanover, Lower Saxony, 30625, 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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Hamburg, 20251, Germany

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Rabin Medical Center - Beilinson Campus

Petah Tikva, Israel

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Pavia, Lombardy, 27100, Italy

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Nagoya, Aichi-ken, 467-8602, Japan

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Kitakyushu, Fukuoka, 802-8555, Japan

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Komatsu, Ishikawa-ken, 923-8560, Japan

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Fujisawa, Kanagawa, 251-0041, Japan

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Kawasaki, Kanagawa, 216-8511, Japan

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Sendai, Miyagi, 980-8574, Japan

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Suwa, Nagano, 392-8510, Japan

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Bunkyo-ku, Tokyo, 113-8655, Japan

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Shinjuku-ku, Tokyo, 162-8655, Japan

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Chiba, 260-8677, Japan

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Fukuoka, 812-8582, Japan

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Monterrey, Nuevo León, 64718, Mexico

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Mexico City, 14080, Mexico

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Querétaro, 38000, Mexico

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Krakow, 31-202, Poland

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Otwock, 05-400, Poland

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Coimbra, 3000-075, Portugal

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Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

Lisbon, 1649-035, Portugal

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Novosibirsk, 630055, Russia

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Saint Petersburg, 197341, Russia

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Bratislava, 833 48, Slovakia

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Seoul, 06351, South Korea

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Seoul, 138-736, South Korea

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Barcelona, 08036, Spain

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Zurich, 8091, Switzerland

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Taipei, 100, Taiwan

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Ankara, Turkey (Türkiye)

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Istanbul, 34093, Turkey (Türkiye)

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Izmir, 35040, Turkey (Türkiye)

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Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

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Glasgow, West Dunbartonshire, G81 4DY, United Kingdom

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Related Publications (6)

• 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

• 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

• 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

• Simonneau G, D'Armini AM, Ghofrani HA, Grimminger F, Jansa P, Kim NH, Mayer E, Pulido T, Wang C, Colorado P, Fritsch A, Meier C, Nikkho S, Hoeper MM. Predictors of long-term outcomes in patients treated with riociguat for chronic thromboembolic pulmonary hypertension: data from the CHEST-2 open-label, randomised, long-term extension trial. Lancet Respir Med. 2016 May;4(5):372-80. doi: 10.1016/S2213-2600(16)30022-4. Epub 2016 Apr 8.

  PMID: 27067478 DERIVED

• Ghofrani HA, D'Armini AM, Grimminger F, Hoeper MM, Jansa P, Kim NH, Mayer E, Simonneau G, Wilkins MR, Fritsch A, Neuser D, Weimann G, Wang C; CHEST-1 Study Group. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl J Med. 2013 Jul 25;369(4):319-29. doi: 10.1056/NEJMoa1209657.

  PMID: 23883377 DERIVED

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe
• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Hypertension, Pulmonary

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: May 27, 2009
• First Posted: May 29, 2009
• Study Start: July 1, 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

DE (10); PL (2); AU (1); SL (1); PT (2); CH (1); CZ (1); JP (11); KR (2); BE (2); FR (4); TW (1); RU (2); DK (1); BR (3); ES (1); TU (3); IL (1); GB (2); IT (1); CA (5); CN (3); AR (1); ME (3); US (8)