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A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH) (PATENT-1)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00810693
First received: December 17, 2008
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 6 minute Walking Distance [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Pulmonary Vascular Resistance (PVR) [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in NT-pro BNP [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in WHO functional class [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
  • Time To Clinical Worsening [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Borg Dyspnoea Score [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in EQ-5D visual analogue scale [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
  • Health Economics questionnaires [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 445
Study Start Date: December 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Riociguat (BAY63-2521)
BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks
Experimental: Arm 2 Drug: Riociguat (BAY63-2521)
BAY63-2521: 1.5mg tid orally for 12 weeks
Active Comparator: Arm 3 Drug: Placebo
Matching Placebo tid orally for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients with symptomatic PAH (Idiopathic, Familial, Associated PAH due to connective tissue disease, congenital heart disease, portal hypertension with liver cirrhosis, or due to anorexigen or amphetamine use)
  • Treatment naive patients and patients pre-treated with an Endothelin Antagonist or a Prostacyclinanalogue (except I.V.).

Exclusion Criteria:

  • All types of pulmonary hypertension except subtypes of Venice Group I specified in the inclusion criteria, severe COPD, uncontrolled arterial hypertension, left heart failure.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810693

  Show 177 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

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00810693     History of Changes
Other Study ID Numbers: 12934, 2008-003482-68
Study First Received: December 17, 2008
Last Updated: June 19, 2012
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
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 May 16, 2013