A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)

NCT00810693 | Completed Phase 3 Results DMC

• 2 other identifiers: 129342008-003482-68
• Study Type: interventional
• Target: 445
• Locations: 29 countries
• Sites: 119

Brief Summary

The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).

Conditions

Pulmonary Hypertension

Keywords

Pulmonary arterial hypertension; PH; Stimulator

Outcome Measures

Primary Outcomes (1)

• 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12

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

  Baseline and week 12

Secondary Outcomes (7)

• Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 12

  Baseline and week 12

• N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 12

  Baseline and week 12

• World Health Organization (WHO) Functional Class - Change From Baseline to Week 12

  Baseline and week 12

• Percentage of Participants With Clinical Worsening

  At week 12

• Borg CR 10 Scale - Change From Baseline to Week 12

  Baseline and week 12

Study Arms (3)

Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT

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 12 weeks

Drug: Riociguat (Adempas, BAY63-2521)

Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT

EXPERIMENTAL

Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks

Drug: Riociguat (Adempas, BAY63-2521)

Placebo

PLACEBO COMPARATOR

Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks

Drug: Placebo

Interventions

Riociguat (Adempas, BAY63-2521) DRUG

BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks

Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT

Placebo DRUG

Matching Placebo tid orally for 12 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 symptomatic PAH (Idiopathic, Familial, Associated PAH due to connective tissue disease, congenital heart disease, portal hypertension with liver cirrhosis, or due to anorexigen or amphetamine use)
• Treatment naive patients and patients pre-treated with an Endothelin Antagonist or a Prostacyclinanalogue (except I.V.).

Sponsors & Collaborators

• Bayer: lead

Study Sites (122)

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Tucson, Arizona, 85724, United States

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La Jolla, California, 92037, United States

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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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Louisville, Kentucky, 40202, United States

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Boston, Massachusetts, 02111, United States

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Boston, Massachusetts, 02115, United States

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Omaha, Nebraska, 68131, United States

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New York, New York, 10032, United States

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Cincinnati, Ohio, 45219, 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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Providence, Rhode Island, 02903, United States

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Dallas, Texas, 75390, United States

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El Paso, Texas, 79902, United States

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Houston, Texas, 77030, United States

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Capital Federal, Argentina

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Darlinghurst, New South Wales, 2010, Australia

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New Lambton Heights, New South Wales, 2305, Australia

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Auchenflower, Queensland, 4066, Australia

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Herston, Queensland, 4029, Australia

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Royal Hobart Hospital

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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Toronto, Ontario, M5G 2N2, 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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Nice, 06200, 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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Petah Tikva, 4941492, Israel

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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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Turin, Piedmont, 10043, Italy

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Nagoya, Aichi-ken, 467-8602, Japan

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Yoshida, Fukui, 910-1193, 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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Sagamihara, Kanagawa, 252-0375, 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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Guadalajara, Jalisco, 44280, Mexico

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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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Christchurch, 8011, New Zealand

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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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Lisbon, 1649-035, Portugal

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Porto, 4099-001, 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, Seoul Teugbyeolsi, 03080, South Korea

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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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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Seville, 41013, Spain

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Linköping, 581 85, Sweden

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Lund, 221 85, Sweden

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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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London, W12 0HS, United Kingdom

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Related Publications (10)

• 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

• 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 RESULT

• 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 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

• 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

• 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

Related Links

• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards

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

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 17, 2008
• First Posted: December 18, 2008
• Study Start: December 17, 2008
• Primary Completion: May 14, 2012
• Study Completion: May 14, 2012
• Last Updated: November 22, 2023
• Results First Posted: February 26, 2014

Record last verified: 2023-11

Locations

GR (1); CZ (1); CN (5); NZ (1); AR (1); BR (4); FR (8); ME (6); PT (4); DE (9); TH (2); TW (3); RU (2); CH (1); BE (2); JP (15); CA (3); AU (6); PL (1); KR (4); DK (1); US (18); IL (1); IT (5); SG (2); ES (3); SE (3); TU (3); GB (4)