BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension

Study Purpose

Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients who have completed 12 weeks of treatment in the double blind trial PATENT 1

    Exclusion Criteria:

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00863681
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bayer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bayer Study Director
Principal Investigator Affiliation Bayer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Italy, Japan, Korea, Republic of, Mexico, Poland, Portugal, Russian Federation, Singapore, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hypertension, Pulmonary

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Omaha, Nebraska

Status

Address

Omaha, Nebraska, 68131

Cleveland, Ohio

Status

Address

Cleveland, Ohio, 44195

Columbus, Ohio

Status

Address

Columbus, Ohio, 43221

Boston, Massachusetts

Status

Address

Boston, Massachusetts, 02111

Boston, Massachusetts

Status

Address

Boston, Massachusetts, 02114

Los Angeles, California

Status

Address

Los Angeles, California, 90073

Sacramento, California

Status

Address

Sacramento, California, 95817

Aurora, Colorado

Status

Address

Aurora, Colorado, 80045

Fairfield, Ohio

Status

Address

Fairfield, Ohio, 45014

Dallas, Texas

Status

Address

Dallas, Texas, 75390-9252

El Paso, Texas

Status

Address

El Paso, Texas, 79902

International Sites

Leuven, Belgium

Status

Address

Leuven, , 3000

Hiroshima, Japan

Status

Address

Hiroshima, , 734-8511

Capital Federal, Argentina

Status

Address

Capital Federal, ,

Darlinghurst, New South Wales, Australia

Status

Address

Darlinghurst, New South Wales, 2010

Auchenflower, Queensland, Australia

Status

Address

Auchenflower, Queensland, 4066

Chermside, Queensland, Australia

Status

Address

Chermside, Queensland, 4032

Hobart, Tasmania, Australia

Status

Address

Hobart, Tasmania, 7000

Prahran, Victoria, Australia

Status

Address

Prahran, Victoria, 3181

Linz, Oberösterreich, Austria

Status

Address

Linz, Oberösterreich, 4020

Innsbruck, Austria

Status

Address

Innsbruck, , 6020

Wien, Austria

Status

Address

Wien, , 1090

Bruxelles - Brussel, Belgium

Status

Address

Bruxelles - Brussel, , 1070

Porto Alegre, Rio Grande Do Sul, Brazil

Status

Address

Porto Alegre, Rio Grande Do Sul, 90020 090

São Paulo, Sao Paulo, Brazil

Status

Address

São Paulo, Sao Paulo, 04012 180

São Paulo, Sao Paulo, Brazil

Status

Address

São Paulo, Sao Paulo, 04020-050

Rio de Janeiro, Brazil

Status

Address

Rio de Janeiro, , 21941-913

Calgary, Alberta, Canada

Status

Address

Calgary, Alberta, T1Y 6J4

Montreal, Quebec, Canada

Status

Address

Montreal, Quebec, H3T 1E2

Guangzhou, Guangdong, China

Status

Address

Guangzhou, Guangdong, 510100

Beijing, China

Status

Address

Beijing, , 100020

Beijing, China

Status

Address

Beijing, , 100037

Shanghai, China

Status

Address

Shanghai, , 200032

Shanghai, China

Status

Address

Shanghai, , 200433

Praha 2, Czechia

Status

Address

Praha 2, , 12808

Aarhus N, Denmark

Status

Address

Aarhus N, , 8200

Besancon, France

Status

Address

Besancon, , 25030

Brest, France

Status

Address

Brest, , F-29609

GRENOBLE Cedex 09, France

Status

Address

GRENOBLE Cedex 09, , 38043

Lille Cedex, France

Status

Address

Lille Cedex, , 59037

Montpellier, France

Status

Address

Montpellier, , 34059

Pessac, France

Status

Address

Pessac, , 33604

Rouen, France

Status

Address

Rouen, , 76031

Heidelberg, Baden-Württemberg, Germany

Status

Address

Heidelberg, Baden-Württemberg, 69126

München, Bayern, Germany

Status

Address

München, Bayern, 81377

Gießen, Hessen, Germany

Status

Address

Gießen, Hessen, 35392

Greifswald, Mecklenburg-Vorpommern, Germany

Status

Address

Greifswald, Mecklenburg-Vorpommern, 17475

Hannover, Niedersachsen, Germany

Status

Address

Hannover, Niedersachsen, 30625

Köln, Nordrhein-Westfalen, Germany

Status

Address

Köln, Nordrhein-Westfalen, 50924

Homburg, Saarland, Germany

Status

Address

Homburg, Saarland, 66421

Dresden, Sachsen, Germany

Status

Address

Dresden, Sachsen, 01307

Leipzig, Sachsen, Germany

Status

Address

Leipzig, Sachsen, 04103

Chaidari, Greece

Status

Address

Chaidari, , 124 62

Trieste, Friuli-Venezia Giulia, Italy

Status

Address

Trieste, Friuli-Venezia Giulia, 34149

Roma, Lazio, Italy

Status

Address

Roma, Lazio, 00161

Milano, Lombardia, Italy

Status

Address

Milano, Lombardia, 20123

Pavia, Lombardia, Italy

Status

Address

Pavia, Lombardia, 27100

Nagoya, Aichi, Japan

Status

Address

Nagoya, Aichi, 467-8602

Kobe, Hyogo, Japan

Status

Address

Kobe, Hyogo, 650-0017

Toride, Ibaraki, Japan

Status

Address

Toride, Ibaraki, 302-0022

Tsukuba, Ibaraki, Japan

Status

Address

Tsukuba, Ibaraki, 305-8576

Kanazawa, Ishikawa, Japan

Status

Address

Kanazawa, Ishikawa, 920-8641

Sendai, Miyagi, Japan

Status

Address

Sendai, Miyagi, 980-8574

Tomigusuku, Okinawa, Japan

Status

Address

Tomigusuku, Okinawa, 901-0243

Bunkyo-ku, Tokyo, Japan

Status

Address

Bunkyo-ku, Tokyo, 113-8655

Mitaka, Tokyo, Japan

Status

Address

Mitaka, Tokyo, 181-8611

Ota-ku, Tokyo, Japan

Status

Address

Ota-ku, Tokyo, 143-8541

Shinjuku-ku, Tokyo, Japan

Status

Address

Shinjuku-ku, Tokyo, 160-8582

Okayama, Japan

Status

Address

Okayama, , 701-1192

Seoul, Korea, Republic of

Status

Address

Seoul, , 03722

Seoul, Korea, Republic of

Status

Address

Seoul, , 05505

Seoul, Korea, Republic of

Status

Address

Seoul, , 06351

Guadalajara, Jalisco, Mexico

Status

Address

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco, 44280

Pulmocritic, Guadalajara, Jalisco, Mexico

Status

Address

Pulmocritic

Guadalajara, Jalisco, 44670

Monterrey, Nuevo Leon, Mexico

Status

Address

Monterrey, Nuevo Leon, 64020

Culiacan, Sinaloa, Mexico

Status

Address

Culiacan, Sinaloa, 80020

Mexico D.F., Mexico

Status

Address

Mexico D.F., , 14080

Querétaro, Mexico

Status

Address

Querétaro, , 38000

Otwock, Poland

Status

Address

Otwock, , 05-400

Coimbra, Portugal

Status

Address

Coimbra, , 3000-075

Lisboa, Portugal

Status

Address

Lisboa, , 1169-024

Lisboa, Portugal

Status

Address

Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

Lisboa, , 1649-035

Moscow, Russian Federation

Status

Address

Moscow, , 121552

St. Petersburg, Russian Federation

Status

Address

St. Petersburg, , 197341

Singapore, Singapore

Status

Address

Singapore, , 119228

Singapore, Singapore

Status

Address

Singapore, , 168752

Umeå, Sweden

Status

Address

Umeå, , 901 85

Zürich, Switzerland

Status

Address

Zürich, , 8091

Kaoshiung, Taiwan

Status

Address

Kaoshiung, , 81346

Taipei, Taiwan

Status

Address

Taipei, , 10002

Taipei, Taiwan

Status

Address

Taipei, , 11217

Bangkok, Thailand

Status

Address

Bangkok, , 10330

Chiang Mai, Thailand

Status

Address

Chiang Mai, , 50200

Ankara, Turkey

Status

Address

Ankara, ,

Istanbul, Turkey

Status

Address

Istanbul, , 34098

Izmir, Turkey

Status

Address

Izmir, , 35-100

Cambridge, Cambridgeshire, United Kingdom

Status

Address

Cambridge, Cambridgeshire, CB23 3RE

Clydebank, West Dunbartonshire, United Kingdom

Status

Address

Clydebank, West Dunbartonshire, G81 4DY

London, United Kingdom

Status

Address

London, , NW3 2QG

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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