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BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension (CHEST-2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00910429
First received: May 27, 2009
Last updated: February 15, 2017
Last verified: February 2017

May 27, 2009
February 15, 2017
July 2009
December 2018   (Final data collection date for primary outcome measure)
Safety and tolerability (e.g. adverse event collection) [ Time Frame: 5 years 2 months and 14 days ]
Safety (adverse event collection) and tolerability [ Time Frame: 3 years ]
Complete list of historical versions of study NCT00910429 on ClinicalTrials.gov Archive Site
Change in 6-Minute Walking Distance (6MWD) from baseline [ Time Frame: 5 years 2 months and 14 days ]
Change in 6-Minute Walking Distance (6MWD) from baseline [ Time Frame: 3 years ]
Not Provided
Not Provided
 
BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension
Long-term Extension, Multicentre, Multi-international 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 Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Pulmonary Hypertension
Drug: Riociguat (Adempas, BAY63-2521)
BAY63-2521 - 1 mg tid - 2,5 mg tid orally until end of study
Experimental: Arm 1
Intervention: Drug: Riociguat (Adempas, 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
237
December 2018
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1

Exclusion Criteria:

  • Patients who have an ongoing serious adverse event from CHEST 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
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Czech Republic,   Denmark,   France,   Germany,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Portugal,   Russian Federation,   Slovakia,   Spain,   Switzerland,   Taiwan,   Turkey,   United Kingdom
 
 
NCT00910429
11349
2008-003539-19 ( EudraCT Number )
Yes
Not Provided
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
February 2017

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