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

Last updated: November 2, 2023
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Diabetes And Hypertension

Pulmonary Arterial Hypertension

High Blood Pressure (Hypertension)

Treatment

Riociguat (Adempas, BAY63-2521)

Clinical Study ID

NCT00910429
11349
2008-003539-19
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 237
Treatment Group(s): 1
Primary Treatment: Riociguat (Adempas, BAY63-2521)
Phase: 3
Study Start date:
July 01, 2009
Estimated Completion Date:
August 19, 2019

Connect with a study center

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    Buenos Aires, Ciudad Auton. de Buenos Aires C1039AAO
    Argentina

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    Capital Federal,
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  • Corrientes, 3400
    Argentina

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    Camperdown, New South Wales 2050
    Australia

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    Auchenflower, Queensland 4066
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    Chermside, Queensland 4032
    Australia

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  • Prahran, Victoria 3181
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    Innsbruck, 6020
    Austria

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  • Wien, 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, Sao Paulo 04020-050
    Brazil

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  • Rio de Janeiro, 21941-913
    Brazil

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    São Paulo, 05403-000
    Brazil

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  • Calgary, Alberta T1Y 6J4
    Canada

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    Hamilton, Ontario L8L 2X2
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    Qingdao, Shandong
    China

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    China

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    China

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    Czechia

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    Denmark

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    Copenhagen, 2100
    Denmark

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    Besancon, 25030
    France

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    France

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    Caen, 14033
    France

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    Clamart Cedex, 92141
    France

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    GRENOBLE Cedex 09, 38043
    France

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    France

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    Lille Cedex, 59037
    France

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    Montpellier, 34059
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    Nice, 06200
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    Pessac, 33604
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    France

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    Strasbourg, 67098
    France

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    Tours, 37000
    France

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    France

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    Germany

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    München, Bayern 81377
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    Germany

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    Regensburg, Bayern 93053
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    Würzburg, Bayern 97074
    Germany

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    Gießen, Hessen 35392
    Germany

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    Germany

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    Greifswald, Mecklenburg-Vorpommern 17475
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    Germany

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    Köln, Nordrhein-Westfalen 50924
    Germany

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    Germany

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    Germany

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    Germany

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    Germany

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    Dublin, DUBLIN 7
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    Petach Tikva,
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    Israel

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    Italy

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    Japan

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    Isehara, Kanagawa 259-1193
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    Suita, Osaka 565-8565
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    Mitaka, Tokyo 181-8611
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    Guadalajara, Jalisco 44670
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    Querétaro, 38000
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    Nieuwegein, 3435 CM
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    Lisboa, 1649-035
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    Porto, 4099-001
    Portugal

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    Russian Federation

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    Russian Federation

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    Spain

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    Turkey

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    Turkey

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    Newcastle, NE7 7DN
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    Birmingham, Alabama 35233
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    Aurora, Colorado 80045
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    Miami, Florida 33136
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    Decatur, Georgia 30030
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    Houston, Texas 77030
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    Murray, Utah 84107
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