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: March 4, 2014
Last verified: March 2014
  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: Allocation: Non-Randomized
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:


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: June 2016
Estimated Primary Completion Date: May 2016 (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
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
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:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: March 4, 2014
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 April 17, 2014