A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.

NCT00855465 | Completed Phase 3 Results DMC

• 2 other identifiers: 113482007-000072-16
• Study Type: interventional
• Target: 262
• Locations: 25 countries
• Sites: 88

Brief Summary

The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

Conditions

Pulmonary Hypertension

Keywords

Chronic thromboembolic pulmonary hypertension; PH; soluble Guanylate Cyclase Stimulator; sGC

Outcome Measures

Primary Outcomes (1)

• 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16

  6-minute walking distance (6MWD) is a measure for the objective evaluation of a participant's functional exercise capacity.

  Baseline and week 16

Secondary Outcomes (7)

• Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16

  Baseline and week 16

• N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 16

  Baseline and week 16

• World Health Organization (WHO) Functional Class - Change From Baseline to Week 16

  Baseline and week 16

• Percentage of Participants With Clinical Worsening

  At week 16

• Borg CR 10 Scale - Change From Baseline to Week 16

  Baseline and week 16

Other Outcomes (34)

• All Caused Mortality

  At visit 6 (week 16)

• Mean Pulmonary Artery Pressure (PAPmean) - Change From Baseline to Week 16

  Baseline and week 16

• Cardiac Index (CI) - Change From Baseline to Week 16

  Baseline and week 16

Study Arms (2)

Riociguat (Adempas, BAY63-2521)_individual dose titration

EXPERIMENTAL

Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks

Drug: Riociguat (Adempas, BAY63-2521)

Placebo

PLACEBO COMPARATOR

Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks

Drug: Placebo

Interventions

Riociguat (Adempas, BAY63-2521) DRUG

BAY63-2521: 1 mg tid - 2,5 mg tid orally for 16 weeks.

Riociguat (Adempas, BAY63-2521)_individual dose titration

Placebo DRUG

Matching Placebo tid orally for 16 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

• Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery.

You may not qualify if:

• All types of pulmonary hypertension except subtypes 4.1 and 4.2 of the Venice Clinical Classification of Pulmonary Hypertension.

Sponsors & Collaborators

• Bayer: lead

Study Sites (89)

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La Jolla, California, 92093, United States

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Sacramento, California, 95817, United States

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Miami, Florida, 33136, 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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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, 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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Qingdao, Shandong, 266003, China

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Beijing, 100020, China

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Beijing, 100037, China

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Beijing, 100038, China

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Shanghai, 200433, China

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Vseobecna fakultni nemocnice

Prague, 12808, Czechia

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Aarhus N, 8200, Denmark

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Brest, F-29609, France

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Caen, 14033, France

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Hopital Antoine Beclere

Clamart, 92141, France

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Lille, 59037, France

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Nice, 06200, France

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Pessac, 33604, France

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Rouen, 76031, France

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Vandœuvre-lès-Nancy, F-54500, France

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Heidelberg, Baden-Wurttemberg, 69120, Germany

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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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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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Hamburg, 20251, Germany

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Pavia, Lombardy, 27100, Italy

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Nagoya, Aichi-ken, 467-8602, Japan

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Seto, Aichi-ken, 489-8642, 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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Suita, Osaka, 565-8565, Japan

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Bunkyo-ku, Tokyo, 113-8655, Japan

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Mitaka, Tokyo, 181-8611, Japan

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Shinjuku-ku, Tokyo, 160-8582, 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, 64020, Mexico

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Monterrey, Nuevo León, 64460, Mexico

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Mexico City, 14080, Mexico

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Querétaro, 38000, Mexico

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Amsterdam, 1081 HV, Netherlands

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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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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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Madrid, 28041, 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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London, W12 0HS, United Kingdom

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Related Publications (11)

• 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 RESULT

• Archer SL. Riociguat for pulmonary hypertension--a glass half full. N Engl J Med. 2013 Jul 25;369(4):386-8. doi: 10.1056/NEJMe1306684. No abstract available.

  PMID: 23883383 RESULT

• 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 RESULT

• Wang C, Jing ZC, Huang YG, Zhou DX, Liu ZH, Meier C, Nikkho S, Curram J, Zhang P, He JG. Riociguat for the treatment of pulmonary hypertension: Chinese subgroup analyses and comparison. Heart Asia. 2016 May 17;8(1):74-82. doi: 10.1136/heartasia-2015-010712. eCollection 2016.

  PMID: 27326239 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

• Kim DY, Kim HJ, Han KH, Han SY, Heo J, Woo HY, Um SH, Kim YH, Kweon YO, Lim HY, Yoon JH, Lee WS, Lee BS, Lee HC, Ryoo BY, Yoon SK. Real-Life Experience of Sorafenib Treatment for Hepatocellular Carcinoma in Korea: From GIDEON Data. Cancer Res Treat. 2016 Oct;48(4):1243-1252. doi: 10.4143/crt.2015.278. Epub 2016 Feb 24.

  PMID: 26910470 RESULT

• Kudo M, Ikeda M, Takayama T, Numata K, Izumi N, Furuse J, Okusaka T, Kadoya M, Yamashita S, Ito Y, Kokudo N. Safety and efficacy of sorafenib in Japanese patients with hepatocellular carcinoma in clinical practice: a subgroup analysis of GIDEON. J Gastroenterol. 2016 Dec;51(12):1150-1160. doi: 10.1007/s00535-016-1204-2. Epub 2016 Apr 22.

  PMID: 27106231 RESULT

• 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 RESULT

• 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 RESULT

• Kim NH, D'Armini AM, Grimminger F, Grunig E, Hoeper MM, Jansa P, Mayer E, Neurohr C, Simonneau G, Torbicki A, Wang C, Fritsch A, Davie N, Ghofrani HA. Haemodynamic effects of riociguat in inoperable/recurrent chronic thromboembolic pulmonary hypertension. Heart. 2017 Apr;103(8):599-606. doi: 10.1136/heartjnl-2016-309621. Epub 2016 Dec 23.

  PMID: 28011757 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

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

clinical-trials-contact@bayerhealthcare.com

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: March 4, 2009
• Study Start: February 23, 2009
• Primary Completion: June 27, 2012
• Study Completion: June 27, 2012
• Last Updated: November 21, 2023
• Results First Posted: March 11, 2014

Record last verified: 2023-11

Locations

GB (3); CA (5); NL (1); PL (2); DK (1); PT (1); ME (4); KR (2); ES (2); CH (1); RU (2); CN (5); DE (12); US (9); CZ (1); BR (3); AU (2); FR (8); JP (15); BE (2); SL (1); IT (1); AR (1); TU (3); TW (1)