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BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension (PATENT-2)

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ClinicalTrials.gov Identifier: NCT00863681
Recruitment Status : Active, not recruiting
First Posted : March 18, 2009
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

March 13, 2009
March 18, 2009
April 3, 2018
March 12, 2009
December 31, 2018   (Final data collection date for primary outcome measure)
Safety (adverse events collection) and tolerability [ Time Frame: Up to 4 years and 10 months ]
Safety (adverse events collection) and tolerability [ Time Frame: 3 years ]
Complete list of historical versions of study NCT00863681 on ClinicalTrials.gov Archive Site
Change in 6MWD (6 minute walking distance) from baseline [ Time Frame: Up to 4 years and 10 months ]
Change in 6MWD from baseline [ Time Frame: 3 years ]
Not Provided
Not Provided
 
BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension
Long-term Extension, Multicentre, Multi-national Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg,1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypertension, Pulmonary
Drug: Riociguat (BAY63-2521)
BAY63-2521: 1mg tid -2.5 mg tid oral until end of study
Experimental: Arm 1
Intervention: Drug: Riociguat (BAY63-2521)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
396
462
December 31, 2018
December 31, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
Czech Republic,   Ireland,   Israel,   Netherlands,   New Zealand,   Slovakia,   Spain
 
NCT00863681
12935
2008-003610-94 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP