Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy (REPLACE)
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ClinicalTrials.gov Identifier: NCT02891850 |
Recruitment Status :
Completed
First Posted : September 8, 2016
Last Update Posted : March 31, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | August 26, 2016 | ||||
First Posted Date ICMJE | September 8, 2016 | ||||
Last Update Posted Date | March 31, 2020 | ||||
Actual Study Start Date ICMJE | January 11, 2017 | ||||
Actual Primary Completion Date | January 29, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Efficacy (Y/N) [ Time Frame: at Week 24 ] The treatment is assessed efficient in case at least 2 out of the following 3 criteria were fulfilled
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy | ||||
Official Title ICMJE | A Prospective, Randomized, International, Multicenter, Double-arm, Controlled, Open-label Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Are on a Stable Dose of Phosphodiesterase-5 Inhibitors (PDE-5i) With or Without Endothelin Receptor Antagonist (ERA), But Not at Treatment Goal | ||||
Brief Summary | To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5 inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients | ||||
Detailed Description | Data from a previous single arm study (RESPITE) indicate that transition from PDE5i to riociguat may be feasible, safe and beneficial in patients not adequately responding to PDE5i. REPLACE is a randomized controlled study to confirm the potential clinical benefit of transition from PDE5i to riociguat. Satisfactory clinical response in patients who are on a stable dose of phosphodiesterase-5inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal will be compared between one group of patients randomized to maintain current treatment and another group where the PDE5i is replaced by riociguat. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Pulmonary Arterial Hypertension | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
225 | ||||
Original Estimated Enrollment ICMJE |
218 | ||||
Actual Study Completion Date ICMJE | March 3, 2020 | ||||
Actual Primary Completion Date | January 29, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Spain, Taiwan, Turkey, United Kingdom, United States | ||||
Removed Location Countries | Australia, Switzerland | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT02891850 | ||||
Other Study ID Numbers ICMJE | 18588 2016-001067-36 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Bayer | ||||
Study Sponsor ICMJE | Bayer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Bayer | ||||
Verification Date | March 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |