Trial Condition(s):

Pulmonary hypertension

A study to evaluate efficacy and safety of oral BAY63-2521 in patients with Pulmonary Arterial Hypertension (PAH) (PATENT-1)

Bayer Identifier:

12934

ClinicalTrials.gov Identifier:

NCT00810693

EudraCT Number:

2008-003482-68

Study Completed

Trial Purpose

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).

Inclusion Criteria
- 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.).
Exclusion Criteria
- All types of pulmonary hypertension except subtypes of Venice Group I specified in the inclusion criteria, severe COPD (chronic obstructive pulmonary disease), uncontrolled arterial hypertension, left heart failure.

Trial Summary

Enrollment Goal
445
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

München, Germany, 81377

Status
Completed
 
Locations

Investigative Site

Homburg, Germany, 66421

Status
Completed
 
Locations

Investigative Site

Gießen, Germany, 35392

Status
Completed
 
Locations

Investigative Site

Leipzig, Germany, 04103

Status
Completed
 
Locations

Investigative Site

Greifswald, Germany, 17475

Status
Completed
 
Locations

Investigative Site

Newcastle, United Kingdom, NE7 7DN

Status
Terminated
 
Locations

Investigative Site

Cambridge, United Kingdom, CB23 3RE

Status
Completed
 
Locations

Investigative Site

London, United Kingdom, NW3 2QG

Status
Completed
 
Locations

Investigative Site

Clydebank, United Kingdom, G81 4DY

Status
Completed
 
Locations

Investigative Site

London, United Kingdom, W12 0HS

Status
Completed
 
Locations

Investigative Site

Aurora, United States, 80045

Status
Completed
 
Locations

Investigative Site

Sacramento, United States, 95817

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02115

Status
Completed
 
Locations

Investigative Site

Columbus, United States, 43221

Status
Completed
 
Locations

Investigative Site

Dresden, Germany, 01307

Status
Completed
 
Locations

Investigative Site

Hannover, Germany, 30625

Status
Completed
 
Locations

Investigative Site

Köln, Germany, 50924

Status
Completed
 
Locations

Investigative Site

Heidelberg, Germany, 69126

Status
Completed
 
Locations

Investigative Site

Fairfield, United States, 45014

Status
Completed
 
Locations

Investigative Site

Torrance, United States, 90502

Status
Terminated
 
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Investigative Site

Boston, United States, 02111

Status
Completed
 
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Investigative Site

Miami, United States, 33136

Status
Terminated
 
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Investigative Site

Baltimore, United States, 21205

Status
Terminated
 
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Investigative Site

Birmingham, United States, 35233

Status
Terminated
 
Locations

Investigative Site

Lille Cedex, France, 59037

Status
Completed
 
Locations

Investigative Site

Caen, France, 14033

Status
Terminated
 
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Investigative Site

Asahikwa, Japan, 078-8510

Status
Terminated
 
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Investigative Site

Shinjuku-ku, Japan, 160-8582

Status
Completed
 
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Investigative Site

Dallas, United States, 75390

Status
Completed
 
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Investigative Site

Cleveland, United States, 44195

Status
Completed
 
Locations

Investigative Site

Rochester, United States, 55905

Status
Terminated
 
Locations

Investigative Site

Los Angeles, United States, 90073

Status
Completed
 
Locations

Investigative Site

Decatur, United States, 30030

Status
Terminated
 
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Investigative Site

Pittsburgh, United States, 15212

Status
Terminated
 
Locations

Investigative Site

Atlanta, United States, 30342

Status
Terminated
 
Locations

Investigative Site

Portland, United States, 04102

Status
Terminated
 
Locations

Investigative Site

Clamart Cedex, France, 92141

Status
Terminated
 
Locations

Investigative Site

Lille Cedex, France, 59037

Status
Terminated
 
Locations

Investigative Site

Bron, France, 69500

Status
Terminated
 
Locations

Investigative Site

BREST, France, F-29609

Status
Completed
 
Locations

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MONTPELLIER, France, 34059

Status
Completed
 
Locations

Investigative Site

GRENOBLE Cedex 09, France, 38043

Status
Completed
 
Locations

Investigative Site

Bunkyo-ku, Japan, 113-8655

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 467-8602

Status
Completed
 
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Kanazawa, Japan, 920-8641

Status
Completed
 
Locations

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Tomigusuku, Japan, 901-0243

Status
Completed
 
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Investigative Site

Kobe, Japan, 650-0017

Status
Completed
 
Locations

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Tokushima, Japan, 770-8503

Status
Terminated
 
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Tsukuba, Japan, 305-8576

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20123

Status
Completed
 
Locations

Investigative Site

Trieste, Italy, 34149

Status
Completed
 
Locations

Investigative Site

Torino, Italy, 10043

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28041

Status
Terminated
 
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Investigative Site

Quebec, Canada, G1V 4G5

Status
Terminated
 
Locations

Investigative Site

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Investigative Site

Monterrey, Mexico, 64020

Status
Completed
 
Locations

Investigative Site

Culiacan, Mexico, 80020

Status
Completed
 
Locations

Investigative Site

Lund, Sweden, 221 85

Status
Completed
 
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Investigative Site

Marseille, France, 13385

Status
Terminated
 
Locations

Investigative Site

Otwock, Poland, 05-400

Status
Completed
 
Locations

Investigative Site

Krakow, Poland, 31-202

Status
Terminated
 
Locations

Investigative Site

Sendai, Japan, 980-8574

Status
Completed
 
Locations

Investigative Site

Ota-ku, Japan, 143-8541

Status
Completed
 
Locations

Investigative Site

Sagamihara, Japan, 252-0375

Status
Completed
 
Locations

Investigative Site

Toyoake, Japan, 470-1192

Status
Terminated
 
Locations

Investigative Site

Okayama, Japan, 701-1192

Status
Completed
 
Locations

Investigative Site

Hiroshima, Japan, 734-8551

Status
Completed
 
Locations

Investigative Site

Hamamatsu, Japan, 430-0929

Status
Terminated
 
Locations

Investigative Site

Fukuoka, Japan, 812-8582

Status
Terminated
 
Locations

Investigative Site

Mitaka, Japan, 181-8611

Status
Completed
 
Locations

Investigative Site

Toride, Japan, 302-0022

Status
Completed
 
Locations

Investigative Site

Bologna, Italy, 40138

Status
Terminated
 
Locations

Investigative Site

Pavia, Italy, 27100

Status
Completed
 
Locations

Investigative Site

Umeå, Sweden, 901 85

Status
Completed
 
Locations

Investigative Site

Praha 2, Czech Republic, 12808

Status
Completed
 
Locations

Investigative Site

DARLINGHURST, Australia, 2010

Status
Completed
 
Locations

Investigative Site

Chermside, Australia, 4032

Status
Completed
 
Locations

Royal Hobart Hospital

HOBART, Australia, 7000

Status
Completed
 
Locations

Investigative Site

Heidelberg, Australia, 3084

Status
Terminated
 
Locations

Investigative Site

Porto, Portugal, 4099-001

Status
Completed
 
Locations

Investigative Site

Buenos Aires, Argentina, C1093AAS

Status
Terminated
 
Locations

Investigative Site

Buenos Aires, Argentina, C1120AAF

Status
Terminated
 
Locations

Investigative Site

Vicente López, Argentina, 1638

Status
Terminated
 
Locations

Investigative Site

Wien, Austria, 1090

Status
Completed
 
Locations

Investigative Site

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Investigative Site

Porto Alegre, Brazil, 90020 090

Status
Completed
 
Locations

Investigative Site

São Paulo, Brazil, 05403-000

Status
Terminated
 
Locations

Investigative Site

Roma, Italy, 00161

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08035

Status
Completed
 
Locations

Investigative Site

Sevilla, Spain, 41013

Status
Completed
 
Locations

Investigative Site

Toronto, Canada, M5G 2N2

Status
Completed
 
Locations

Investigative Site

Montreal, Canada, H3T 1E2

Status
Completed
 
Locations

Investigative Site

Calgary, Canada, T1Y 6J4

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

Investigative Site

AMSTERDAM, Netherlands, 1081 HV

Status
Terminated
 
Locations

Investigative Site

Mexico D.F., Mexico, 14080

Status
Completed
 
Locations

Investigative Site

Linköping, Sweden, 581 85

Status
Completed
 
Locations

Investigative Site

Aarhus N, Denmark, 8200

Status
Completed
 
Locations

Investigative Site

Jerusalem, Israel, 9112001

Status
Terminated
 
Locations

Investigative Site

Petah Tikva, Israel, 4941492

Status
Completed
 
Locations

Investigative Site

Rio de Janeiro, Brazil, 21941-900

Status
Completed
 
Locations

Investigative Site

St. Petersburg, Russia, 197341

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100020

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 05505

Status
Completed
 
Locations

Investigative Site

Zürich, Switzerland, 8091

Status
Completed
 
Locations

Investigative Site

Taipei, Taiwan, China, 10016

Status
Completed
 
Locations

Investigative Site

Kaoshiung, Taiwan, China, 81346

Status
Completed
 
Locations

Investigative Site

Christchurch, New Zealand, 8011

Status
Completed
 
Locations

Investigative Site

Tel Aviv, Israel, 6423906

Status
Terminated
 
Locations

Investigative Site

Auchenflower, Australia, 4066

Status
Completed
 
Locations

Investigative Site

PRAHRAN, Australia, 3181

Status
Completed
 
Locations

Investigative Site

New Lambton Heights, Australia, 2305

Status
Completed
 
Locations

Investigative Site

Coimbra, Portugal, 3000-075

Status
Completed
 
Locations

Investigative Site

Almada, Portugal, 2801-951

Status
Terminated
 
Locations

Investigative Site

Buenos Aires, Argentina, C1039AAO

Status
Terminated
 
Locations

Investigative Site

Linz, Austria, 4020

Status
Completed
 
Locations

Investigative Site

Ankara, Turkey

Status
Completed
 
Locations

Investigative Site

Izmir, Turkey, 35-100

Status
Completed
 
Locations

Investigative Site

Istanbul, Turkey, 34098

Status
Completed
 
Locations

Investigative Site

Haidari, Greece, 124 62

Status
Completed
 
Locations

Investigative Site

Kallithea / Athens, Greece, 17674

Status
Terminated
 
Locations

Investigative Site

São Paulo, Brazil, 04024-002

Status
Completed
 
Locations

Investigative Site

São Paulo, Brazil, 04012 180

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 121552

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100037

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200433

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200032

Status
Completed
 
Locations

Investigative Site

Guangzhou, China, 510100

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 135-710

Status
Completed
 
Locations

Investigative Site

Taipei, Taiwan, China, 11217

Status
Completed
 
Locations

Investigative Site

Taichung, Taiwan, China, 40705

Status
Terminated
 
Locations

Investigative Site

Singapore, Singapore, 168752

Status
Completed
 
Locations

Investigative Site

Singapore, Singapore, 119228

Status
Completed
 
Locations

Investigative Site

Dublin, Ireland

Status
Terminated
 
Locations

Investigative Site

Houston, United States, 77030

Status
Completed
 
Locations

Investigative Site

Newark, United States, 07103

Status
Terminated
 
Locations

Investigative Site

ROTTERDAM, Netherlands, 3015 CE

Status
Terminated
 
Locations

Investigative Site

Providence, United States, 02903

Status
Completed
 
Locations

Investigative Site

Rouen, France, 76031

Status
Completed
 
Locations

Investigative Site

Tours, France, 37000

Status
Terminated
 
Locations

Investigative Site

Gainesville, United States, 32610

Status
Terminated
 
Locations

Investigative Site

Cincinnati, United States, 45219

Status
Completed
 
Locations

Investigative Site

Yoshida, Japan, 910-1193

Status
Completed
 
Locations

Investigative Site

St. Louis, United States, 63110

Status
Terminated
 
Locations

Investigative Site

Iowa City, United States, 52242

Status
Terminated
 
Locations

Investigative Site

Sheffield, United Kingdom, S10 2JF

Status
Terminated
 
Locations

Investigative Site

Baltimore, United States, 21201

Status
Terminated
 
Locations

Investigative Site

Seoul, South Korea, 120-752

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02114

Status
Terminated
 
Locations

Investigative Site

El Paso, United States, 79902

Status
Completed
 
Locations

Investigative Site

Capital Federal, Argentina

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 03080

Status
Completed
 
Locations

Investigative Site

Omaha, United States, 68131

Status
Completed
 
Locations

Investigative Site

La Jolla, United States, 92037

Status
Completed
 
Locations

Investigative Site

New York, United States, 10032

Status
Completed
 
Locations

Investigative Site

Ann Arbor, United States, 48109

Status
Terminated
 
Locations

Investigative Site

Weston, United States, 33331

Status
Terminated
 
Locations

Investigative Site

Louisville, United States, 40202

Status
Completed
 
Locations

Investigative Site

Tuscon, United States, 85724

Status
Completed
 
Locations

Investigative Site

Guadalajara, Mexico, 44670

Status
Completed
 
Locations

Investigative Site

Guadalajara, Mexico, 44280

Status
Completed
 
Locations

Investigative Site

Querétaro, Mexico, 38000

Status
Completed
 
Locations

Investigative Site

Buenos Aires, Argentina, C1181ACH

Status
Terminated
 
Locations

Investigative Site

Cleveland, United States, 44106

Status
Terminated
 
Locations

Investigative Site

Istanbul, Turkey, 34304

Status
Terminated
 
Locations

Investigative Site

Chiang Mai, Thailand, 50200

Status
Completed
 
Locations

Investigative Site

Bangkok, Thailand, 10400

Status
Terminated
 
Locations

Investigative Site

Lisboa, Portugal, 1169-024

Status
Completed
 
Locations

Investigative Site

Lisboa, Portugal, 1649-035

Status
Completed
 
Locations

Investigative Site

PESSAC, France, 33604

Status
Completed
 
Locations

Investigative Site

Hamilton, Canada, L8L 2X2

Status
Terminated
 
Locations

Investigative Site

Bangkok, Thailand, 10330

Status
Completed
 
Locations

Investigative Site

NICE, France, 06200

Status
Completed
 
Locations

Investigative Site

Sarasota, United States, 34239

Status
Terminated
 
Locations

Investigative Site

BESANCON, France, 25030

Status
Completed
 
Locations

Investigative Site

Fresno, United States, 93721

Status
Terminated
 
Locations

Investigative Site

Rochester, United States, 14642

Status
Terminated
 

Trial Design