Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy (REPLACE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02891850 |
Recruitment Status :
Completed
First Posted : September 8, 2016
Results First Posted : January 22, 2021
Last Update Posted : January 22, 2021
|
Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Pulmonary Arterial Hypertension |
Interventions |
Drug: Riociguat (Adempas, BAY63-2521) Drug: Sildenafil Drug: Tadalafil |
Enrollment | 225 |
Participant Flow
Recruitment Details | Study was conducted at multiple centers in 21 countries between 11-JAN-2017 (first participant first visit) and 03-MAR-2020 (last participant last visit). |
Pre-assignment Details | 293 participants were screened in this study. Of these, 67 participants did not enter the treatment period (60 screening failures; 2 withdraw during screening; 2 withdraw following physician decision; 3 withdraw due to other reasons). 226 participants were randomized, of which 1 participant withdraw before treated. |
Arm/Group Title | Riociguat | PDE-5i |
---|---|---|
![]() |
Participants received BAY63-2521 tablets at a dosage of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, and 2.5 mg three times a day (TID) for 24 weeks, started with 1.0 mg TID, followed by a dose adjustment period of 8 weeks, then stayed at the optimal dose period of 16 weeks. | Participants remained on their current pulmonary arterial hypertension (PAH) treatment on tadalafil (20 to 40 mg/day) or sildenafil (at least 60 mg/day) for 24 weeks at the discretion of the investigator. |
Period Title: Overall Study | ||
Started [1] | 111 | 114 |
Completed | 104 | 107 |
Not Completed | 7 | 7 |
Reason Not Completed | ||
Adverse Event | 3 | 0 |
Death | 0 | 4 |
Physician Decision | 1 | 0 |
Pregnancy | 1 | 0 |
Withdrawal by Subject | 2 | 3 |
[1]
Treated
|
Baseline Characteristics
Arm/Group Title | Riociguat | PDE-5i | Total | |
---|---|---|---|---|
![]() |
Participants received BAY63-2521 tablets at a dosage of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, and 2.5 mg three times a day (TID) for 24 weeks, started with 1.0 mg TID, followed by a dose adjustment period of 8 weeks, then stayed at the optimal dose period of 16 weeks. | Participants remained on their current pulmonary arterial hypertension (PAH) treatment on tadalafil (20 to 40 mg/day) or sildenafil (at least 60 mg/day) for 24 weeks at the discretion of the investigator. | Total of all reporting groups | |
Overall Number of Baseline Participants | 111 | 114 | 225 | |
![]() |
[Not Specified]
|
|||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 111 participants | 114 participants | 225 participants | |
49.4 (16.16) | 49.2 (15.64) | 49.3 (15.86) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 111 participants | 114 participants | 225 participants | |
Female |
82 73.9%
|
95 83.3%
|
177 78.7%
|
|
Male |
29 26.1%
|
19 16.7%
|
48 21.3%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 111 participants | 114 participants | 225 participants | |
Hispanic or Latino |
32 28.8%
|
31 27.2%
|
63 28.0%
|
|
Not Hispanic or Latino |
75 67.6%
|
80 70.2%
|
155 68.9%
|
|
Unknown or Not Reported |
4 3.6%
|
3 2.6%
|
7 3.1%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 111 participants | 114 participants | 225 participants | |
American Indian or Alaska Native |
1 0.9%
|
0 0.0%
|
1 0.4%
|
|
Asian |
17 15.3%
|
19 16.7%
|
36 16.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
4 3.6%
|
5 4.4%
|
9 4.0%
|
|
White |
86 77.5%
|
89 78.1%
|
175 77.8%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
3 2.7%
|
1 0.9%
|
4 1.8%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Therapeutic Area Head |
Organization: | Bayer |
Phone: | (+) 1-888-8422937 |
EMail: | clinical-trials-contact@bayer.com |
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT02891850 |
Other Study ID Numbers: |
18588 2016-001067-36 ( EudraCT Number ) |
First Submitted: | August 26, 2016 |
First Posted: | September 8, 2016 |
Results First Submitted: | January 4, 2021 |
Results First Posted: | January 22, 2021 |
Last Update Posted: | January 22, 2021 |