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:
EudraCT Number:
EU CT Number:
Not Available
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 | |
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Locations Investigative Site München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Homburg, Germany, 66421 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gießen, Germany, 35392 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leipzig, Germany, 04103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Greifswald, Germany, 17475 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cambridge, United Kingdom, CB23 3RE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, NW3 2QG | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Clydebank, United Kingdom, G81 4DY | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, W12 0HS | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aurora, United States, 80045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sacramento, United States, 95817 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boston, United States, 02115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43221 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Köln, Germany, 50924 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Germany, 69126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fairfield, United States, 45014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boston, United States, 02111 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lille Cedex, France, 59037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shinjuku-ku, Japan, 160-8582 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dallas, United States, 75390 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cleveland, United States, 44195 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90073 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BREST, France, F-29609 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MONTPELLIER, France, 34059 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GRENOBLE Cedex 09, France, 38043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bunkyo-ku, Japan, 113-8655 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 467-8602 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kanazawa, Japan, 920-8641 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tomigusuku, Japan, 901-0243 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kobe, Japan, 650-0017 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tsukuba, Japan, 305-8576 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Trieste, Italy, 34149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Torino, Italy, 10043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Monterrey, Mexico, 64020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Culiacan, Mexico, 80020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lund, Sweden, 221 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Otwock, Poland, 05-400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sendai, Japan, 980-8574 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ota-ku, Japan, 143-8541 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sagamihara, Japan, 252-0375 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Okayama, Japan, 701-1192 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hiroshima, Japan, 734-8551 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mitaka, Japan, 181-8611 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toride, Japan, 302-0022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Umeå, Sweden, 901 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 2, Czech Republic, 12808 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site DARLINGHURST, Australia, 2010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Herston, Australia, 4029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Hobart Hospital HOBART, Australia, 7000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Porto, Portugal, 4099-001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Porto Alegre, Brazil, 90020 090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00161 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sevilla, Spain, 41013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M5G 2N2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H3T 1E2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Calgary, Canada, T1Y 6J4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mexico D.F., Mexico, 14080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linköping, Sweden, 581 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aarhus N, Denmark, 8200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Petah Tikva, Israel, 4941492 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rio de Janeiro, Brazil, 21941-913 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 197341 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 05505 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zürich, Switzerland, 8091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kaohsiung City, Taiwan, China, 813414 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Christchurch, New Zealand, 8011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Auchenflower, Australia, 4066 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PRAHRAN, Australia, 3181 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Lambton Heights, Australia, 2305 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Coimbra, Portugal, 3000-075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linz, Austria, 4020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ankara, Turkey | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Izmir, Turkey, 35-100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Istanbul, Turkey, 34098 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chaidari, Greece, 124 62 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site São Paulo, Brazil, 04020-050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site São Paulo, Brazil, 04012 180 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 121552 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200433 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guangzhou, China, 510100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 06351 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 168752 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 119228 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Providence, United States, 02903 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rouen, France, 76031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cincinnati, United States, 45219 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yoshida, Japan, 910-1193 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 03722 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site El Paso, United States, 79902 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Capital Federal, Argentina | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 03080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Omaha, United States, 68131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site La Jolla, United States, 92037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New York, United States, 10032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Louisville, United States, 40202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tuscon, United States, 85724 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guadalajara, Mexico, 44670 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guadalajara, Mexico, 44280 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Querétaro, Mexico, 38000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chiang Mai, Thailand, 50200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lisboa, Portugal, 1169-024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lisboa, Portugal, 1649-035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PESSAC, France, 33604 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bangkok, Thailand, 10330 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NICE, France, 06200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BESANCON, France, 25030 | 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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