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


Tracking Information

Start Date  ICMJEFebruary 2009
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: March 3, 2009)		6 Minute Walking Distance [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00855465 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: December 14, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: March 3, 2009)
  • 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 ]

Descriptive Information

Brief Title  ICMJEA Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.
Official Title  ICMJERandomized, 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)
Brief Summary

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).

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEPulmonary Hypertension
Intervention  ICMJE
  • Drug: Riociguat (BAY63-2521)
    BAY63-2521: 1 mg tid - 2,5 mg tid orally for 16 weeks.
  • Drug: Placebo
    Matching Placebo tid orally for 16 weeks
Study Arms / Comparison Groups
  • Arm 1: Experimental
    Intervention: Drug: Riociguat (BAY63-2521)
  • Arm 2: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE270
Estimated Completion DateApril 2011
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages18 Years to 75 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Bayer Clinical Trials Contactclinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4')(+)1-888-84 22937
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Czech Republic,   Denmark,   France,   Germany,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Portugal,   Russian Federation,   Slovakia,   Spain,   Switzerland,   Taiwan,   Turkey,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00855465
Responsible PartyTherapeutic Area Head, Bayer Healthcare AG
Study ID Numbers  ICMJE11348, EudraCT: 2007-000072-16, CHEST 1
Study Sponsor  ICMJEBayer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Bayer Study DirectorBayer
Information Provided ByBayer