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A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH. (CHEST-1)
This study is currently recruiting participants.
Verified January 2012 by Bayer

First Received on December 15, 2008.   Last Updated on January 18, 2012   History of Changes
Sponsor: 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: 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 Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

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 CR 10 Scale [ 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 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Riociguat (BAY63-2521)
BAY63-2521: 1 mg tid - 2,5 mg tid orally for 16 weeks.
Placebo Comparator: Arm 2 Drug: Placebo
Matching Placebo tid orally for 16 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 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 131 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 AG
ClinicalTrials.gov Identifier: NCT00855465     History of Changes
Other Study ID Numbers: 11348, 2007-000072-16
Study First Received: December 15, 2008
Last Updated: January 18, 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;   Israel: Ministry of Health;   Italy: Ministry of Health;   Japan: Ministry of Health and Welfare;   Korea, Republic of: Food and Drug Administration;   Mexico: Ministry of Health;   Netherlands: Medicines Evaluation 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 Kingdom: Medicines and Healthcare Products Regulatory Agency;   United States: Food and Drug Administration

Keywords provided by Bayer:
Chronic thromboembolic pulmonary 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 February 09, 2012



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