BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: Riociguat (Adempas, BAY63-2521)	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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).

Resource links provided by NLM:

MedlinePlus related topics: Pulmonary Hypertension

Drug Information available for: Riociguat

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Safety and tolerability (e.g. adverse event collection) [ Time Frame: 5 years 2 months and 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in 6-Minute Walking Distance (6MWD) from baseline [ Time Frame: 5 years 2 months and 14 days ] [ Designated as safety issue: No ]


Enrollment:	237
Study Start Date:	July 2009
Estimated Study Completion Date:	April 2019
Estimated Primary Completion Date:	March 2019 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Riociguat (Adempas, BAY63-2521) BAY63-2521 - 1 mg tid - 2,5 mg tid orally until end of study

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910429

Show 129 Study Locations

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ghofrani HA, D'Armini AM, Grimminger F, Hoeper MM, Jansa P, Kim NH, Mayer E, Simonneau G, Wilkins MR, Fritsch A, Neuser D, Weimann G, Wang C; CHEST-1 Study Group. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl J Med. 2013 Jul 25;369(4):319-29. doi: 10.1056/NEJMoa1209657.


Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT00910429 History of Changes
Other Study ID Numbers:	11349 2008-003539-19
Study First Received:	May 27, 2009
Last Updated:	August 15, 2016
Health Authority:	Argentina: National Administration of Drugs, Foods and Medical Technology Australia: Department of Health Austria: Ministry of Labor, Health and Social Affairs Belgium: Ministry of Social Affairs, Public Health and the Environment Brazil: Ministry of Health Canada: Health Protection Branch China: Ministry of Health- State Food and Drug Administration Czech Republic: Ministry of Health Denmark: Danish Medicines Agency France: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Israel: Ministry of Health Italy: Ministry of Health Japan: Ministry of Health and Welfare Korea, Republic of:Korea: Food and Drug Administration Mexico: Ministry of Health Netherlands: Medicines Evaluetion Board Poland: Ministry of Health and Social Security- Drug Institute Portugal: Ministry of Health Russia: Ministry of Health Slovakia: State Institute for Drug Control Spain: Ministry of Health and Consumption Switzerland: Federal Office of Public Health Taiwan: Department of Health Turkey: Ministry of Health United States: Food and Drug Administration

Keywords provided by Bayer:


Chronic thromboembolic Hypertension PH soluble Guanylate Cyclase Stimulator sGC

Additional relevant MeSH terms:


Hypertension Hypertension, Pulmonary Vascular Diseases	Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 26, 2016

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