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: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Hypertension, Pulmonary
Drug: Riociguat (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-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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Safety (adverse events collection) and tolerability [ Time Frame: Up to 4 years and 10 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in 6MWD (6 minute walking distance) from baseline [ Time Frame: Up to 4 years and 10 months ] [ Designated as safety issue: No ]

Enrollment: 396
Study Start Date: March 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Riociguat (BAY63-2521)
BAY63-2521: 1mg tid -2.5 mg tid oral 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00863681

  Show 177 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: NCT00863681     History of Changes
Other Study ID Numbers: 12935, 2008-003610-94
Study First Received: March 13, 2009
Last Updated: January 27, 2014
Health Authority: Argentina: National Administration of Drugs, Foods and Medical Technology
Austria: Ministry of Labor, Health and Social Affairs
Australia: Department of Health
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
Greece: Ministry of Health and Welfare
Ireland: Irisch Medicines Board
Israel: Ministry of Health
Italy: Ministry of Health
Japan: Ministry of Health and Welfare
Korea: Food and Drug Administration
Mexico: Ministry of Health
Netherlands: Medicines Evaluetion Board
New Zealand: Medicines and Medical Devices Safety Authority
Poland: Ministry of Health and Social Security - Drug Institute
Portugal: Ministry of Health
Russia: Ministry of Health
Singapore: Ministry of Health
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
Switzerland: Federal Office of Public Health
Thailand: Ministry of Public Health
Taiwan: Department of Health
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Bayer:
Pulmonary arterial hypertension
PH
Stimulator

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014