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)
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | ||
|---|---|---|---|
Locations Investigative Site München, Germany, 81377 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Homburg, Germany, 66421 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Gießen, Germany, 35392 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Leipzig, Germany, 04103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Greifswald, Germany, 17475 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Newcastle, United Kingdom, NE7 7DN | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Cambridge, United Kingdom, CB23 3RE | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site London, United Kingdom, NW3 2QG | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Clydebank, United Kingdom, G81 4DY | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site London, United Kingdom, W12 0HS | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Aurora, United States, 80045 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Sacramento, United States, 95817 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Boston, United States, 02115 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Columbus, United States, 43221 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Dresden, Germany, 01307 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Hannover, Germany, 30625 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Köln, Germany, 50924 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Heidelberg, Germany, 69126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Fairfield, United States, 45014 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Torrance, United States, 90502 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Boston, United States, 02111 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Miami, United States, 33136 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Baltimore, United States, 21205 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Birmingham, United States, 35233 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Lille Cedex, France, 59037 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Caen, France, 14033 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Asahikwa, Japan, 078-8510 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Shinjuku-ku, Japan, 160-8582 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Dallas, United States, 75390 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Cleveland, United States, 44195 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Rochester, United States, 55905 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Los Angeles, United States, 90073 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Decatur, United States, 30030 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Pittsburgh, United States, 15212 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Atlanta, United States, 30342 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Portland, United States, 04102 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Clamart Cedex, France, 92141 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Lille Cedex, France, 59037 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bron, France, 69500 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site BREST, France, F-29609 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site MONTPELLIER, France, 34059 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site GRENOBLE Cedex 09, France, 38043 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bunkyo-ku, Japan, 113-8655 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Nagoya, Japan, 467-8602 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kanazawa, Japan, 920-8641 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Tomigusuku, Japan, 901-0243 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kobe, Japan, 650-0017 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Tokushima, Japan, 770-8503 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Tsukuba, Japan, 305-8576 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Milano, Italy, 20123 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Trieste, Italy, 34149 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Torino, Italy, 10043 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Madrid, Spain, 28041 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Quebec, Canada, G1V 4G5 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Monterrey, Mexico, 64020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Culiacan, Mexico, 80020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Lund, Sweden, 221 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Marseille, France, 13385 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Otwock, Poland, 05-400 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Krakow, Poland, 31-202 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Sendai, Japan, 980-8574 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Ota-ku, Japan, 143-8541 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Sagamihara, Japan, 252-0375 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Toyoake, Japan, 470-1192 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Okayama, Japan, 701-1192 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Hiroshima, Japan, 734-8551 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Hamamatsu, Japan, 430-0929 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Fukuoka, Japan, 812-8582 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Mitaka, Japan, 181-8611 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Toride, Japan, 302-0022 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bologna, Italy, 40138 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Pavia, Italy, 27100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Umeå, Sweden, 901 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Praha 2, Czech Republic, 12808 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site DARLINGHURST, Australia, 2010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Chermside, Australia, 4032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Royal Hobart Hospital HOBART, Australia, 7000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Heidelberg, Australia, 3084 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Porto, Portugal, 4099-001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Buenos Aires, Argentina, C1093AAS | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Buenos Aires, Argentina, C1120AAF | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Vicente López, Argentina, 1638 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Innsbruck, Austria, 6020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Porto Alegre, Brazil, 90020 090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site São Paulo, Brazil, 05403-000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Roma, Italy, 00161 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Sevilla, Spain, 41013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Toronto, Canada, M5G 2N2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Montreal, Canada, H3T 1E2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Calgary, Canada, T1Y 6J4 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1070 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site AMSTERDAM, Netherlands, 1081 HV | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Mexico D.F., Mexico, 14080 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Linköping, Sweden, 581 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Aarhus N, Denmark, 8200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Jerusalem, Israel, 9112001 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Petah Tikva, Israel, 4941492 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Rio de Janeiro, Brazil, 21941-900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site St. Petersburg, Russia, 197341 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Beijing, China, 100020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Seoul, South Korea, 05505 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Zürich, Switzerland, 8091 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Taipei, Taiwan, China, 10016 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kaoshiung, Taiwan, China, 81346 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Christchurch, New Zealand, 8011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Tel Aviv, Israel, 6423906 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Auchenflower, Australia, 4066 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site PRAHRAN, Australia, 3181 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site New Lambton Heights, Australia, 2305 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Coimbra, Portugal, 3000-075 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Almada, Portugal, 2801-951 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Buenos Aires, Argentina, C1039AAO | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Linz, Austria, 4020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Ankara, Turkey | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Izmir, Turkey, 35-100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Istanbul, Turkey, 34098 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Haidari, Greece, 124 62 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kallithea / Athens, Greece, 17674 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site São Paulo, Brazil, 04024-002 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site São Paulo, Brazil, 04012 180 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Moscow, Russia, 121552 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Beijing, China, 100037 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Shanghai, China, 200433 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Shanghai, China, 200032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Guangzhou, China, 510100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Seoul, South Korea, 135-710 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Taipei, Taiwan, China, 11217 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Taichung, Taiwan, China, 40705 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Singapore, Singapore, 168752 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Singapore, Singapore, 119228 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Dublin, Ireland | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Houston, United States, 77030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Newark, United States, 07103 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site ROTTERDAM, Netherlands, 3015 CE | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Providence, United States, 02903 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Rouen, France, 76031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Tours, France, 37000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Gainesville, United States, 32610 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Cincinnati, United States, 45219 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Yoshida, Japan, 910-1193 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site St. Louis, United States, 63110 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Iowa City, United States, 52242 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Sheffield, United Kingdom, S10 2JF | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Baltimore, United States, 21201 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Seoul, South Korea, 120-752 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Boston, United States, 02114 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site El Paso, United States, 79902 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Capital Federal, Argentina | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Seoul, South Korea, 03080 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Omaha, United States, 68131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site La Jolla, United States, 92037 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site New York, United States, 10032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Ann Arbor, United States, 48109 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Weston, United States, 33331 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Louisville, United States, 40202 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Tuscon, United States, 85724 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Guadalajara, Mexico, 44670 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Guadalajara, Mexico, 44280 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Querétaro, Mexico, 38000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Buenos Aires, Argentina, C1181ACH | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Cleveland, United States, 44106 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Istanbul, Turkey, 34304 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Chiang Mai, Thailand, 50200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bangkok, Thailand, 10400 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Lisboa, Portugal, 1169-024 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Lisboa, Portugal, 1649-035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site PESSAC, France, 33604 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Hamilton, Canada, L8L 2X2 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bangkok, Thailand, 10330 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site NICE, France, 06200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Sarasota, United States, 34239 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site BESANCON, France, 25030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Fresno, United States, 93721 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Rochester, United States, 14642 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- 6 minutes walking distance (6MWD) - Change from baseline to week 12Timeframe: Baseline and week 12
Secondary Outcome
- Pulmonary vascular resistance (PVR) - Change from baseline to week 12Timeframe: Baseline and week 12
- N-terminal prohormone of brain natriuretic peptide (NT-proBNP) - Change from baseline to week 12Timeframe: Baseline and week 12
- World Health Organization (WHO) functional class - Change from baseline to week 12Timeframe: Baseline and week 12
- Percentage of participants with clinical worseningTimeframe: At week 12
- Borg CR 10 scale - Change from baseline to week 12Timeframe: Baseline and week 12
- EQ-5D utility score - Change from baseline to week 12Timeframe: Baseline and week 12
- Living with pulmonary hypertension (LPH) questionnaire - Change from baseline to week 12Timeframe: Baseline and week 12
Additional Information
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