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


Tracking Information

Start Date  ICMJEDecember 2008
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: December 17, 2008)		6 minute Walking Distance [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00810693 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: September 28, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: December 17, 2008)
  • 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 ]

Descriptive Information

Brief Title  ICMJEA Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)
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 Symptomatic Pulmonary Arterial Hypertension (PAH)
Brief Summary

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).

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: 1mg tid - 2.5mg tid orally for 12 weeks
  • Drug: Riociguat (BAY63-2521)
    BAY63-2521: 1.5mg tid orally for 12 weeks
  • Drug: Placebo
    Matching Placebo tid orally for 12 weeks
Study Arms / Comparison Groups
  • Arm 1: Experimental
    Intervention: Drug: Riociguat (BAY63-2521)
  • Arm 2: Experimental
    Intervention: Drug: Riociguat (BAY63-2521)
  • Arm 3: Active Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE462
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 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.
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,   Greece,   Ireland,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Poland,   Portugal,   Russian Federation,   Singapore,   Slovakia,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00810693
Responsible PartyTherapeutic Area Head, Bayer Healthcare AG
Study ID Numbers  ICMJE12934, EudraCT: 2008-003482-68, Patent-1
Study Sponsor  ICMJEBayer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Bayer Study DirectorBayer
Information Provided ByBayer