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History of Changes for Study: NCT00810693
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)
Latest version (submitted October 14, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 17, 2008 None (earliest Version on record)
2 January 8, 2009 Study Status
3 January 9, 2009 Contacts/Locations, Conditions, Oversight and Study Status
4 February 5, 2009 Contacts/Locations, Study Status, Conditions and Oversight
5 March 5, 2009 Contacts/Locations and Study Status
6 April 2, 2009 Contacts/Locations and Study Status
7 May 4, 2009 Contacts/Locations, Study Status and Study Identification
8 June 4, 2009 Contacts/Locations, Study Status, Study Identification and Conditions
9 July 1, 2009 Contacts/Locations and Study Status
10 August 19, 2009 Contacts/Locations, Study Status and Study Identification
11 September 8, 2009 Contacts/Locations and Study Status
12 September 28, 2009 Contacts/Locations, Outcome Measures and Study Status
13 October 19, 2009 Contacts/Locations and Study Status
14 November 11, 2009 Study Status and Contacts/Locations
15 December 7, 2009 Contacts/Locations and Study Status
16 January 4, 2010 Contacts/Locations and Study Status
17 January 28, 2010 Contacts/Locations and Study Status
18 February 3, 2010 Study Status and Study Identification
19 February 21, 2010 Contacts/Locations, Study Status and Study Identification
20 March 21, 2010 Contacts/Locations and Study Status
21 April 15, 2010 Study Status
22 June 30, 2010 Contacts/Locations and Study Status
23 July 30, 2010 Contacts/Locations and Study Status
24 August 30, 2010 Contacts/Locations and Study Status
25 September 9, 2010 Study Status and Contacts/Locations
26 September 28, 2010 Contacts/Locations, Eligibility and Study Status
27 October 25, 2010 Contacts/Locations and Study Status
28 November 19, 2010 Study Status and Contacts/Locations
29 December 9, 2010 Contacts/Locations and Study Status
30 January 6, 2011 Study Status and Contacts/Locations
31 January 30, 2011 Contacts/Locations and Study Status
32 February 28, 2011 Contacts/Locations and Study Status
33 March 28, 2011 Contacts/Locations and Study Status
34 April 28, 2011 Study Status and Contacts/Locations
35 May 5, 2011 Study Status and Contacts/Locations
36 June 7, 2011 Contacts/Locations and Study Status
37 July 4, 2011 Contacts/Locations and Study Status
38 August 4, 2011 Contacts/Locations and Study Status
39 August 16, 2011 Study Status, Contacts/Locations and Study Identification
40 August 24, 2011 Contacts/Locations and Study Status
41 September 20, 2011 Study Status and Contacts/Locations
42 October 18, 2011 Contacts/Locations, Study Status and Study Identification
43 November 9, 2011 Study Status and Contacts/Locations
44 December 8, 2011 Study Status, Contacts/Locations and Study Identification
45 January 4, 2012 Contacts/Locations and Study Status
46 January 17, 2012 Contacts/Locations and Study Status
47 February 15, 2012 Contacts/Locations and Study Status
48 March 6, 2012 Recruitment Status, Study Status, Contacts/Locations and Study Design
49 June 4, 2012 Recruitment Status and Study Status
50 June 19, 2012 Sponsor/Collaborators and Study Status
51 June 18, 2013 Study Status
52 January 24, 2014 Outcome Measures, Arms and Interventions, Study Status, Sponsor/Collaborators, References, Results, Contacts/Locations and Eligibility
53 October 27, 2014 Study Status and References
54 May 6, 2016 Study Status and References
55 October 14, 2016 Contacts/Locations, References and Study Status
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Study NCT00810693
Submitted Date:  December 17, 2008 (v1)

Open or close this module Study Identification
Unique Protocol ID: 12934
Brief Title: A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)
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)
Secondary IDs: EudraCT: 2008-003482-68
Patent-1
Open or close this module Study Status
Record Verification: December 2008
Overall Status: Recruiting
Study Start: December 2008
Primary Completion: November 2010 [Anticipated]
Study Completion: November 2010 [Anticipated]
First Submitted: December 17, 2008
First Submitted that
Met QC Criteria:
December 17, 2008
First Posted: December 18, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 17, 2008
Last Update Posted: December 18, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Bayer
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Pulmonary Hypertension
Keywords: Pulmonary arterial hypertension
PH
Stmulator
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 462 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm 1 Drug: Riociguat (BAY63-2521)
BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks
Experimental: Arm 2 Drug: Riociguat (BAY63-2521)
BAY63-2521: 1.5mg tid orally for 12 weeks
Active Comparator: Arm 3 Drug: Placebo
Matching Placebo tid orally for 12 weeks
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 6 minute Walking Distance
[ Time Frame: after 12 weeks ]

Secondary Outcome Measures:
1. Change from baseline in Pulmonary Vascular Resistance (PVR)
[ Time Frame: after 12 weeks ]

2. Change from baseline in NT-pro BNP
[ Time Frame: after 12 weeks ]

3. Change from baseline in WHO functional class
[ Time Frame: after 12 weeks ]

4. Time To Clinical Worsening
[ Time Frame: after 12 weeks ]

5. Change from baseline in Borg Dyspnoea Score
[ Time Frame: after 12 weeks ]

6. Change from baseline in EQ-5D visual analogue scale
[ Time Frame: after 12 weeks ]

7. Health Economics questionnaries
[ Time Frame: after 12 weeks ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Bayer Clinical Trials Contact
Email: clinical-trials-contact@bayerhealthcare.com
Central Contact Backup: For trial location information (Phone Menu Options '3' or '4')
Telephone: (+)1-888-84 22937
Study Officials: Bayer Study Director
Study Director
Bayer
Locations: United States, Alabama
[Not yet recruiting]
Mobile, Alabama, United States, 36617
United States, California
[Not yet recruiting]
Sacramento, California, United States, 95817
[Not yet recruiting]
Torrance, California, United States, 90502-2004
United States, Colorado
[Not yet recruiting]
Aurora, Colorado, United States, 80045
United States, Florida
[Not yet recruiting]
Miami, Florida, United States, 33125
United States, Georgia
[Not yet recruiting]
Atlanta, Georgia, United States, 30322
United States, Massachusetts
[Not yet recruiting]
Boston, Massachusetts, United States, 02111
[Not yet recruiting]
Boston, Massachusetts, United States, 02114-2696
United States, Ohio
[Not yet recruiting]
Cleveland, Ohio, United States, 44195
[Not yet recruiting]
Columbus, Ohio, United States, 43210-1240
[Not yet recruiting]
Fairfield, Ohio, United States, 45014
United States, Texas
[Not yet recruiting]
Dallas, Texas, United States, 75390
[Not yet recruiting]
Houston, Texas, United States, 77030
Argentina, Buenos Aires
[Not yet recruiting]
Vicente López, Buenos Aires, Argentina, B1602DOH
Argentina, Capital Federal
[Not yet recruiting]
Buenos Aires, Capital Federal, Argentina, 1078
[Not yet recruiting]
Buenos Aires, Capital Federal, Argentina, C1039AAO
[Not yet recruiting]
Buenos Aires, Capital Federal, Argentina, C1120AAF
Australia, New South Wales
[Not yet recruiting]
Sydney, New South Wales, Australia, 2010
Australia, Queensland
[Not yet recruiting]
Brisbane, Queensland, Australia, 4032
[Not yet recruiting]
Brisbane, Queensland, Australia, 4066
Australia, Western Australia
[Not yet recruiting]
Perth, Western Australia, Australia, 6000
Austria
[Not yet recruiting]
Wien, Austria, 1090
Austria, Tirol
[Not yet recruiting]
Innsbruck, Tirol, Austria, 6020
Belgium
[Not yet recruiting]
Bruxelles - Brussel, Belgium, 1070
[Not yet recruiting]
Leuven, Belgium, 3000
Brazil, RJ
[Not yet recruiting]
Rio de Janeiro, RJ, Brazil, 21949 900
Brazil, RS
[Not yet recruiting]
Porto Alegre, RS, Brazil, 90470 340
Brazil, SP
[Not yet recruiting]
Sao Paulo, SP, Brazil, 04012-000
[Not yet recruiting]
Sao Paulo, SP, Brazil, 04023-900
[Not yet recruiting]
Sao Paulo, SP, Brazil, 05403-900
Canada
[Not yet recruiting]
Quebec, Canada, G1V 4G5
Canada, Ontario
[Not yet recruiting]
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
[Not yet recruiting]
Montreal, Quebec, Canada, H3T 1E2
Czech Republic
[Not yet recruiting]
Praha 2, Czech Republic, 12808
[Not yet recruiting]
Praha 4, Czech Republic, 140 21
Denmark
[Not yet recruiting]
ask Contact, Denmark
France
[Not yet recruiting]
Brest, France, F-29609
[Not yet recruiting]
Bron, France, 69500
[Not yet recruiting]
Clamart Cedex, France, 92141
[Not yet recruiting]
Lille, France, 59037
[Not yet recruiting]
Lille Cedex, France, 59037
[Not yet recruiting]
Montpellier, France, 34059
[Not yet recruiting]
Strasbourg, France, 67091
[Not yet recruiting]
Vandoeuvre Les Nancy, France, 54511
Germany, Bayern
[Not yet recruiting]
München, Bayern, Germany, 81377
Germany, Hessen
[Recruiting]
Gießen, Hessen, Germany, 35392
Germany, Niedersachsen
[Not yet recruiting]
Hannover, Niedersachsen, Germany, 30625
Germany, Saarland
[Not yet recruiting]
Homburg, Saarland, Germany, 66421
Germany, Sachsen
[Not yet recruiting]
Dresden, Sachsen, Germany, 01307
Italy
[Not yet recruiting]
Bologna, Italy, 40138
[Not yet recruiting]
Pavia, Italy, 27100
[Not yet recruiting]
Roma, Italy, 00155
Japan
[Not yet recruiting]
Hiroshima, Japan, 734-8551
[Not yet recruiting]
Okayama, Japan, 700-8558
[Not yet recruiting]
Okayama, Japan, 701-1192
Japan, Aichi
[Not yet recruiting]
Nagoya, Aichi, Japan, 467-8602
[Not yet recruiting]
Toyoake, Aichi, Japan, 470-1192
Japan, Hokkaido
[Not yet recruiting]
Asahikwa, Hokkaido, Japan, 078-8802
Japan, Ishikawa
[Not yet recruiting]
Kanazawa, Ishikawa, Japan, 920-8641
Japan, Kanagawa
[Not yet recruiting]
Sagamihara, Kanagawa, Japan, 228-0829
Japan, Miyagi
[Not yet recruiting]
Sendai, Miyagi, Japan, 980-8574
Japan, Okinawa
[Not yet recruiting]
Tomigusuku, Okinawa, Japan, 901-0243
Japan, Shizuoka
[Not yet recruiting]
Hamamatsu, Shizuoka, Japan, 430-0929
Japan, Tokyo
[Not yet recruiting]
Bunkyo-ku, Tokyo, Japan, 113-8655
[Not yet recruiting]
Ota-ku, Tokyo, Japan, 143-8541
[Not yet recruiting]
Shinjuku-ku, Tokyo, Japan, 160-8582
Korea, Republic of
[Not yet recruiting]
Seoul, Korea, Republic of, 135-710
[Not yet recruiting]
Seoul, Korea, Republic of, 138-736
Netherlands
[Not yet recruiting]
Amsterdam, Netherlands, 1081 HV
Poland
[Not yet recruiting]
Krakow, Poland, 31-202
[Not yet recruiting]
Warszawa, Poland, 01-138
Singapore
[Not yet recruiting]
Singapore, Singapore, 119074
[Not yet recruiting]
Singapore, Singapore, 168752
Spain
[Not yet recruiting]
Barcelona, Spain, 08035
[Not yet recruiting]
Barcelona, Spain, 08036
[Not yet recruiting]
Madrid, Spain, 28041
[Not yet recruiting]
Sevilla, Spain, 41013
Sweden
[Not yet recruiting]
Göteborg, Sweden, 413 45
[Not yet recruiting]
Linköping, Sweden, 581 85
[Not yet recruiting]
Lund, Sweden, 221 85
[Not yet recruiting]
Stockholm, Sweden, 171 76
[Not yet recruiting]
Umeå, Sweden, 901 85
Switzerland
[Not yet recruiting]
Zürich, Switzerland, 8091
Taiwan
[Not yet recruiting]
Taichung, Taiwan, 40705
[Not yet recruiting]
Taipei, Taiwan, 100
[Not yet recruiting]
Taipei, Taiwan
United Kingdom, Cambridgeshire
[Not yet recruiting]
Cambridge, Cambridgeshire, United Kingdom, CB3 8RE
United Kingdom, Greater London
[Not yet recruiting]
London, Greater London, United Kingdom, NW3 2QG
United Kingdom, Strathclyde
[Not yet recruiting]
Glasgow, Strathclyde, United Kingdom, G81 4HX
United Kingdom, Tyne and Wear
[Not yet recruiting]
Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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