A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH. - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00855465

Purpose

The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

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 Chronic Thromboembolic Pulmonary Hypertension.

Resource links provided by NLM:

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: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in Pulmonary Vascular Resistance (PVR) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Change from baseline in NT-pro BNP [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Change from baseline in WHO functional class [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Change from baseline in Borg Dyspnoea Score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Time to clinical worsening [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Change from baseline in EQ-5D and LPH. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Safety variables: adverse events, laboratory parameters, ECG, vital signs. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	270
Study Start Date:	February 2009
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: 1 mg tid - 2,5 mg tid orally for 16 weeks.
Arm 2: Placebo Comparator	Drug: Placebo Matching Placebo tid orally for 16 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 CTEPH either inoperable or with persistent or recurrent PH after surgery.

Exclusion Criteria:

All types of pulmonary hypertension except subtypes 4.1 and 4.2 of the Venice Clinical Classification of Pulmonary Hypertension.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855465

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 86 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

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	11348, EudraCT: 2007-00072-16, CHEST 1
Study First Received:	December 15, 2008
Last Updated:	September 7, 2009
ClinicalTrials.gov Identifier:	NCT00855465 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Chronic thromboembolic pulmonary hypertension, PH
Stimulator

Study placed in the following topic categories:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases
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 11, 2009