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

EU CT Number:

Not Available

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

Loading...
Locations
Locations
Locations

Investigative Site

München, Germany, 81377

Locations

Investigative Site

Homburg, Germany, 66421

Locations

Investigative Site

Gießen, Germany, 35392

Locations

Investigative Site

Leipzig, Germany, 04103

Locations

Investigative Site

Greifswald, Germany, 17475

Locations

Investigative Site

Newcastle, United Kingdom, NE7 7DN

Locations

Investigative Site

Cambridge, United Kingdom, CB23 3RE

Locations

Investigative Site

London, United Kingdom, NW3 2QG

Locations

Investigative Site

Clydebank, United Kingdom, G81 4DY

Locations

Investigative Site

London, United Kingdom, W12 0HS

Locations

Investigative Site

Aurora, United States, 80045

Locations

Investigative Site

Sacramento, United States, 95817

Locations

Investigative Site

Boston, United States, 02115

Locations

Investigative Site

Columbus, United States, 43221

Locations

Investigative Site

Dresden, Germany, 01307

Locations

Investigative Site

Hannover, Germany, 30625

Locations

Investigative Site

Köln, Germany, 50924

Locations

Investigative Site

Heidelberg, Germany, 69126

Locations

Investigative Site

Fairfield, United States, 45014

Locations

Investigative Site

Torrance, United States, 90502

Locations

Investigative Site

Boston, United States, 02111

Locations

Investigative Site

Miami, United States, 33136

Locations

Investigative Site

Baltimore, United States, 21205

Locations

Investigative Site

Birmingham, United States, 35233

Locations

Investigative Site

Lille Cedex, France, 59037

Locations

Investigative Site

Caen, France, 14033

Locations

Investigative Site

Asahikwa, Japan, 078-8510

Locations

Investigative Site

Shinjuku-ku, Japan, 160-8582

Locations

Investigative Site

Dallas, United States, 75390

Locations

Investigative Site

Cleveland, United States, 44195

Locations

Investigative Site

Rochester, United States, 55905

Locations

Investigative Site

Los Angeles, United States, 90073

Locations

Investigative Site

Decatur, United States, 30030

Locations

Investigative Site

Pittsburgh, United States, 15212

Locations

Investigative Site

Atlanta, United States, 30342

Locations

Investigative Site

Portland, United States, 04102

Locations

Investigative Site

Clamart Cedex, France, 92141

Locations

Investigative Site

Lille Cedex, France, 59037

Locations

Investigative Site

Bron, France, 69500

Locations

Investigative Site

BREST, France, F-29609

Locations

Investigative Site

MONTPELLIER, France, 34059

Locations

Investigative Site

GRENOBLE Cedex 09, France, 38043

Locations

Investigative Site

Bunkyo-ku, Japan, 113-8655

Locations

Investigative Site

Nagoya, Japan, 467-8602

Locations

Investigative Site

Kanazawa, Japan, 920-8641

Locations

Investigative Site

Tomigusuku, Japan, 901-0243

Locations

Investigative Site

Kobe, Japan, 650-0017

Locations

Investigative Site

Tokushima, Japan, 770-8503

Locations

Investigative Site

Tsukuba, Japan, 305-8576

Locations

Investigative Site

Milano, Italy, 20123

Locations

Investigative Site

Trieste, Italy, 34149

Locations

Investigative Site

Torino, Italy, 10043

Locations

Investigative Site

Madrid, Spain, 28041

Locations

Investigative Site

Quebec, Canada, G1V 4G5

Locations

Investigative Site

LEUVEN, Belgium, 3000

Locations

Investigative Site

Monterrey, Mexico, 64020

Locations

Investigative Site

Culiacan, Mexico, 80020

Locations

Investigative Site

Lund, Sweden, 221 85

Locations

Investigative Site

Marseille, France, 13385

Locations

Investigative Site

Otwock, Poland, 05-400

Locations

Investigative Site

Krakow, Poland, 31-202

Locations

Investigative Site

Sendai, Japan, 980-8574

Locations

Investigative Site

Ota-ku, Japan, 143-8541

Locations

Investigative Site

Sagamihara, Japan, 252-0375

Locations

Investigative Site

Toyoake, Japan, 470-1192

Locations

Investigative Site

Okayama, Japan, 701-1192

Locations

Investigative Site

Hiroshima, Japan, 734-8551

Locations

Investigative Site

Hamamatsu, Japan, 430-0929

Locations

Investigative Site

Fukuoka, Japan, 812-8582

Locations

Investigative Site

Mitaka, Japan, 181-8611

Locations

Investigative Site

Toride, Japan, 302-0022

Locations

Investigative Site

Bologna, Italy, 40138

Locations

Investigative Site

Pavia, Italy, 27100

Locations

Investigative Site

Umeå, Sweden, 901 85

Locations

Investigative Site

Praha 2, Czech Republic, 12808

Locations

Investigative Site

DARLINGHURST, Australia, 2010

Locations

Investigative Site

Chermside, Australia, 4032

Locations

Royal Hobart Hospital

HOBART, Australia, 7000

Locations

Investigative Site

Heidelberg, Australia, 3084

Locations

Investigative Site

Porto, Portugal, 4099-001

Locations

Investigative Site

Buenos Aires, Argentina, C1093AAS

Locations

Investigative Site

Buenos Aires, Argentina, C1120AAF

Locations

Investigative Site

Vicente López, Argentina, 1638

Locations

Investigative Site

Wien, Austria, 1090

Locations

Investigative Site

Innsbruck, Austria, 6020

Locations

Investigative Site

Porto Alegre, Brazil, 90020 090

Locations

Investigative Site

São Paulo, Brazil, 05403-000

Locations

Investigative Site

Roma, Italy, 00161

Locations

Investigative Site

Barcelona, Spain, 08036

Locations

Investigative Site

Barcelona, Spain, 08035

Locations

Investigative Site

Sevilla, Spain, 41013

Locations

Investigative Site

Toronto, Canada, M5G 2N2

Locations

Investigative Site

Montreal, Canada, H3T 1E2

Locations

Investigative Site

Calgary, Canada, T1Y 6J4

Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1070

Locations

Investigative Site

AMSTERDAM, Netherlands, 1081 HV

Locations

Investigative Site

Mexico D.F., Mexico, 14080

Locations

Investigative Site

Linköping, Sweden, 581 85

Locations

Investigative Site

Aarhus N, Denmark, 8200

Locations

Investigative Site

Jerusalem, Israel, 9112001

Locations

Investigative Site

Petah Tikva, Israel, 4941492

Locations

Investigative Site

Rio de Janeiro, Brazil, 21941-900

Locations

Investigative Site

St. Petersburg, Russia, 197341

Locations

Investigative Site

Beijing, China, 100020

Locations

Investigative Site

Seoul, South Korea, 05505

Locations

Investigative Site

Zürich, Switzerland, 8091

Locations

Investigative Site

Taipei, Taiwan, China, 10016

Locations

Investigative Site

Kaoshiung, Taiwan, China, 81346

Locations

Investigative Site

Christchurch, New Zealand, 8011

Locations

Investigative Site

Tel Aviv, Israel, 6423906

Locations

Investigative Site

Auchenflower, Australia, 4066

Locations

Investigative Site

PRAHRAN, Australia, 3181

Locations

Investigative Site

New Lambton Heights, Australia, 2305

Locations

Investigative Site

Coimbra, Portugal, 3000-075

Locations

Investigative Site

Almada, Portugal, 2801-951

Locations

Investigative Site

Buenos Aires, Argentina, C1039AAO

Locations

Investigative Site

Linz, Austria, 4020

Locations

Investigative Site

Ankara, Turkey

Locations

Investigative Site

Izmir, Turkey, 35-100

Locations

Investigative Site

Istanbul, Turkey, 34098

Locations

Investigative Site

Haidari, Greece, 124 62

Locations

Investigative Site

Kallithea / Athens, Greece, 17674

Locations

Investigative Site

São Paulo, Brazil, 04024-002

Locations

Investigative Site

São Paulo, Brazil, 04012 180

Locations

Investigative Site

Moscow, Russia, 121552

Locations

Investigative Site

Beijing, China, 100037

Locations

Investigative Site

Shanghai, China, 200433

Locations

Investigative Site

Shanghai, China, 200032

Locations

Investigative Site

Guangzhou, China, 510100

Locations

Investigative Site

Seoul, South Korea, 135-710

Locations

Investigative Site

Taipei, Taiwan, China, 11217

Locations

Investigative Site

Taichung, Taiwan, China, 40705

Locations

Investigative Site

Singapore, Singapore, 168752

Locations

Investigative Site

Singapore, Singapore, 119228

Locations

Investigative Site

Dublin, Ireland

Locations

Investigative Site

Houston, United States, 77030

Locations

Investigative Site

Newark, United States, 07103

Locations

Investigative Site

ROTTERDAM, Netherlands, 3015 CE

Locations

Investigative Site

Providence, United States, 02903

Locations

Investigative Site

Rouen, France, 76031

Locations

Investigative Site

Tours, France, 37000

Locations

Investigative Site

Gainesville, United States, 32610

Locations

Investigative Site

Cincinnati, United States, 45219

Locations

Investigative Site

Yoshida, Japan, 910-1193

Locations

Investigative Site

St. Louis, United States, 63110

Locations

Investigative Site

Iowa City, United States, 52242

Locations

Investigative Site

Sheffield, United Kingdom, S10 2JF

Locations

Investigative Site

Baltimore, United States, 21201

Locations

Investigative Site

Seoul, South Korea, 120-752

Locations

Investigative Site

Boston, United States, 02114

Locations

Investigative Site

El Paso, United States, 79902

Locations

Investigative Site

Capital Federal, Argentina

Locations

Investigative Site

Seoul, South Korea, 03080

Locations

Investigative Site

Omaha, United States, 68131

Locations

Investigative Site

La Jolla, United States, 92037

Locations

Investigative Site

New York, United States, 10032

Locations

Investigative Site

Ann Arbor, United States, 48109

Locations

Investigative Site

Weston, United States, 33331

Locations

Investigative Site

Louisville, United States, 40202

Locations

Investigative Site

Tuscon, United States, 85724

Locations

Investigative Site

Guadalajara, Mexico, 44670

Locations

Investigative Site

Guadalajara, Mexico, 44280

Locations

Investigative Site

Querétaro, Mexico, 38000

Locations

Investigative Site

Buenos Aires, Argentina, C1181ACH

Locations

Investigative Site

Cleveland, United States, 44106

Locations

Investigative Site

Istanbul, Turkey, 34304

Locations

Investigative Site

Chiang Mai, Thailand, 50200

Locations

Investigative Site

Bangkok, Thailand, 10400

Locations

Investigative Site

Lisboa, Portugal, 1169-024

Locations

Investigative Site

Lisboa, Portugal, 1649-035

Locations

Investigative Site

PESSAC, France, 33604

Locations

Investigative Site

Hamilton, Canada, L8L 2X2

Locations

Investigative Site

Bangkok, Thailand, 10330

Locations

Investigative Site

NICE, France, 06200

Locations

Investigative Site

Sarasota, United States, 34239

Locations

Investigative Site

BESANCON, France, 25030

Locations

Investigative Site

Fresno, United States, 93721

Locations

Investigative Site

Rochester, United States, 14642

Trial Design