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

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00810693

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

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 questionnaries [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	462
Study Start Date:	December 2008
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Riociguat (BAY63-2521) BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks
Arm 2: Experimental	Drug: Riociguat (BAY63-2521) BAY63-2521: 1.5mg tid orally for 12 weeks
Arm 3: Active Comparator	Drug: Placebo Matching Placebo tid orally for 12 weeks

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients with symptomatic PAH
Treatment naive patients and patients pre-treated with an Endothelin Antagonist or a Prostacyclinanalogue.

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

Contacts

Contact: Bayer Clinical Trials Contact		clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4')	(+)1-888-84 22937

Show 119 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

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No publications provided

Responsible Party:	Bayer Healthcare AG ( Therapeutic Area Head )
Study ID Numbers:	12934, EudraCT: 2008-003482-68, Patent-1
Study First Received:	December 17, 2008
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00810693 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Pulmonary arterial hypertension
PH
Stimulator

Study placed in the following topic categories:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Idiopathic Pulmonary Hypertension
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on September 03, 2009