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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00863681
First received: March 13, 2009
Last updated: October 28, 2014
Last verified: October 2014

March 13, 2009
October 28, 2014
March 2009
May 2016   (final data collection date for primary outcome measure)
Safety (adverse events collection) and tolerability [ Time Frame: Up to 4 years and 10 months ] [ Designated as safety issue: Yes ]
Safety (adverse events collection) and tolerability [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Change in 6MWD from baseline [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)
Ghofrani HA, Galiè N, Grimminger F, Grünig E, Humbert M, Jing ZC, Keogh AM, Langleben D, Kilama MO, Fritsch A, Neuser D, Rubin LJ; PATENT-1 Study Group. Riociguat for the treatment of pulmonary arterial hypertension. N Engl J Med. 2013 Jul 25;369(4):330-40. doi: 10.1056/NEJMoa1209655.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
396
June 2016
May 2016   (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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Poland,   Portugal,   Russian Federation,   Singapore,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   United Kingdom
 
NCT00863681
12935, 2008-003610-94
Yes
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2014

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