Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

NCT ID: NCT01784562

Last Updated: 2016-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.

Detailed Description

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Conditions

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Hypertension, Pulmonary

Interventions

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Adempas (Riociguat, BAY63-2521)

Individual dosing of riociguat between 0.5 and 2.5 mg three times daily based on patient's well being and blood pressure. (The individual optimal dose should be determined during the initial 8-week titration phase based on patient's monitoring of systolic blood pressure and well-being.)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery

Exclusion Criteria

* All types of pulmonary hypertension other than Dana Point Classification Group 4
* Operable patients listed for PEA (Pulmonary Endarterectomy)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Tucson, Arizona, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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Aurora, Colorado, United States

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Weston, Florida, United States

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Chicago, Illinois, United States

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Iowa City, Iowa, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Omaha, Nebraska, United States

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Newark, New Jersey, United States

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New York, New York, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Fairfield, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Providence, Rhode Island, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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Houston, Texas, United States

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Graz, Styria, Austria

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Innsbruck, Tyrol, Austria

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Vienna, Vienna, Austria

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Bruxelles - Brussel, , Belgium

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Leuven, , Belgium

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Calgary, Alberta, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Bogotá, Bogota D.C., Colombia

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Bogotá, Cundinamarca, Colombia

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Cali, Valle del Cauca Department, Colombia

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Bogotá, , Colombia

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Santa Fé, , Colombia

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Prague, , Czechia

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Aarhus N, , Denmark

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Besançon, , France

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Brest, , France

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Bron, , France

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Caen, , France

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Le Kremlin-Bicêtre, , France

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Montpellier, , France

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Pessac, , France

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Rouen, , France

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Vandœuvre-lès-Nancy, , France

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Heidelberg, Baden-Wurttemberg, Germany

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München, Bavaria, Germany

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Regensburg, Bavaria, Germany

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Würzburg, Bavaria, Germany

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Hamburg, City state of Hamburg, Germany

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Giessen, Hesse, Germany

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Hanover, Lower Saxony, Germany

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Greifswald, Mecklenburg-Vorpommern, Germany

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Cologne, North Rhine-Westphalia, Germany

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Homburg, Saarland, Germany

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Dresden, Saxony, Germany

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Leipzig, Saxony, Germany

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Pavia, , Italy

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Roma, , Italy

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Trieste, , Italy

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Nagoya, Aichi-ken, Japan

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Chiba, Chiba, Japan

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Sendai, Miyagi, Japan

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Bunkyo-ku, Tokyo, Japan

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Mexico City, Mexico City, Mexico

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México D.F., Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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Amsterdam, , Netherlands

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Nieuwegein, , Netherlands

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Rotterdam, , Netherlands

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Coimbra, Coimbra District, Portugal

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Lisbon, Lisbon District, Portugal

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Almada, , Portugal

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Lisbon, , Portugal

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Novosibirsk, , Russia

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Saint Petersburg, , Russia

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Barcelona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Madrid, Madrid, Spain

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Seville, Sevilla, Spain

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Linköping, , Sweden

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Lund, , Sweden

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Umeå, , Sweden

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Bern, Canton of Bern, Switzerland

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Sankt Gallen, Canton of St. Gallen, Switzerland

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Lausanne, Canton of Vaud, Switzerland

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Zurich, Canton of Zurich, Switzerland

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Ankara, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Cambridge, Cambridgeshire, United Kingdom

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Sheffield, South Yorkshire, United Kingdom

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Newcastle upon Tyne, Tyne and Wear, United Kingdom

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Glasgow, West Dunbartonshire, United Kingdom

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Countries

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United States Austria Belgium Canada Colombia Czechia Denmark France Germany Italy Japan Mexico Netherlands Portugal Russia Spain Sweden Switzerland Turkey (Türkiye) United Kingdom

References

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McLaughlin VV, Jansa P, Nielsen-Kudsk JE, Halank M, Simonneau G, Grunig E, Ulrich S, Rosenkranz S, Gomez Sanchez MA, Pulido T, Pepke-Zaba J, Barbera JA, Hoeper MM, Vachiery JL, Lang I, Carvalho F, Meier C, Mueller K, Nikkho S, D'Armini AM. Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study. BMC Pulm Med. 2017 Dec 28;17(1):216. doi: 10.1186/s12890-017-0563-7.

Reference Type DERIVED
PMID: 29282032 (View on PubMed)

Other Identifiers

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2012-002104-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16097

Identifier Type: -

Identifier Source: org_study_id

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