Trial · NCT02891850

Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy

NCT02891850, Phase 4, Completed, Bayer; results first posted 2021-01-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy. Trials, record NCT02891850. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02891850

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy
NCT number: NCT02891850
Status: Completed
Phases: Phase 4
Enrollment: 225 participants, actual
Lead sponsor: Bayer
Conditions: Pulmonary Arterial Hypertension
Interventions: Riociguat (Adempas, BAY63-2521), Sildenafil, Tadalafil
First posted: 2016-09-08
Last updated: 2021-02-26
Other registries' IDs: eudract:2016-001067-36
Results first posted: 2021-01-22

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Satisfactory Clinical Response at Week 24	At Week 24	The treatment is assessed as efficient (participants with satisfactory clinical response) in case at least 2 out of the following 3 criteria were fulfilled * 6 Minute Walking Distance increase by ≥ 10% or ≥ 30 m from baseline to Week 24 * World Health Organization Functional Class (WHO FC) I or II at Week 24 * N-terminal pro-brain natriuretic peptide (NT-proBNP) reduction ≥ 30% from baseline to Week 24 (NT-proBNP ratio Week 24/baseline ≤ 0.7) and in absence of the defined criteria of clinical worsening
Secondary	Change in 6 Minute Walking Distance (6MWD) With Last Observation Carried Forward From Baseline to 24 Weeks	From baseline and up to 24 weeks	Six-minute walk distance (6MWD) was conducted to test the physical limitations of the participant by assessing the participant's exercise capacity. The distance walked by the participant in 6 minutes was measured.
Secondary	Change in N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) With Last Observation Carried Forward at Week 24	From baseline and up to 24 weeks	N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.
Secondary	Change in World Health Organization Functional Class (WHO FC) With Last Observation Carried Forward From Baseline to Week 24	From baseline and up to 24 weeks	The participant's functional class was determined by using the WHO classification. Possible classes range from I (patients with pulmonary hypertension (PH) but without resulting limitation of physical activity) to IV (patients with PH with inability to carry out any physical activity without symptoms).
Secondary	Number of Participants With Adjudicated Clinical Worsening at Week 24	Up to 24 weeks	Clinical worsening was defined as death of any cause, hospitalization due to worsening pulmonary arterial hypertension (PAH) (adjudicated) or disease progression (adjudicated).

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Satisfactory Clinical Response at Week 24	At Week 24	Full Analysis Set (FAS) with evaluable participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in 6 Minute Walking Distance (6MWD) With Last Observation Carried Forward From Baseline to 24 Weeks	From baseline and up to 24 weeks	Full Analysis Set (FAS) with evaluable participants	meters (m)	MEAN
SECONDARY	Change in N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) With Last Observation Carried Forward at Week 24	From baseline and up to 24 weeks	Full Analysis Set (FAS) with evaluable participants	picograms per milliliter (pg/mL)	MEAN
SECONDARY	Change in World Health Organization Functional Class (WHO FC) With Last Observation Carried Forward From Baseline to Week 24	From baseline and up to 24 weeks	Full Analysis Set (FAS) with evaluable participants	class	MEAN
SECONDARY	Number of Participants With Adjudicated Clinical Worsening at Week 24	Up to 24 weeks	Full Analysis Set (FAS) with evaluable participants	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Satisfactory Clinical Response at Week 24	Riociguat	With satisfactory clinical response	45		Participants
Number of Participants With Satisfactory Clinical Response at Week 24	PDE-5i	With satisfactory clinical response	23		Participants
Number of Participants With Satisfactory Clinical Response at Week 24	Riociguat	Without satisfactory clinical response	66		Participants
Number of Participants With Satisfactory Clinical Response at Week 24	PDE-5i	Without satisfactory clinical response	90		Participants
Change in 6 Minute Walking Distance (6MWD) With Last Observation Carried Forward From Baseline to 24 Weeks	Riociguat		36.448	Standard Deviation 65.9748	meters (m)
Change in 6 Minute Walking Distance (6MWD) With Last Observation Carried Forward From Baseline to 24 Weeks	PDE-5i		13.884	Standard Deviation 67.1552	meters (m)
Change in N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) With Last Observation Carried Forward at Week 24	Riociguat		-88.234	Standard Deviation 533.9179	picograms per milliliter (pg/mL)
Change in N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) With Last Observation Carried Forward at Week 24	PDE-5i		81.414	Standard Deviation 1267.6142	picograms per milliliter (pg/mL)
Change in World Health Organization Functional Class (WHO FC) With Last Observation Carried Forward From Baseline to Week 24	Riociguat		-0.5	Standard Deviation 0.58	class
Change in World Health Organization Functional Class (WHO FC) With Last Observation Carried Forward From Baseline to Week 24	PDE-5i		-0.2	Standard Deviation 0.62	class

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Riociguat	111
Overall Study	STARTED	PDE-5i	114
Overall Study	COMPLETED	Riociguat	104
Overall Study	COMPLETED	PDE-5i	107
Overall Study	NOT COMPLETED	Riociguat	7
Overall Study	NOT COMPLETED	PDE-5i	7

Source ClinicalTrials.gov

Adverse events374

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Riociguat	0	111	0
other	Anaemia	Blood and lymphatic system disorders	PDE-5i	1	114	1
other	Anaemia megaloblastic	Blood and lymphatic system disorders	Riociguat	0	111	0
other	Anaemia megaloblastic	Blood and lymphatic system disorders	PDE-5i	1	114	1
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Riociguat	2	111	2
other	Iron deficiency anaemia	Blood and lymphatic system disorders	PDE-5i	0	114	0
other	Leukopenia	Blood and lymphatic system disorders	Riociguat	0	111	0
other	Leukopenia	Blood and lymphatic system disorders	PDE-5i	2	114	2
other	Lymphopenia	Blood and lymphatic system disorders	Riociguat	0	111	0
other	Lymphopenia	Blood and lymphatic system disorders	PDE-5i	1	114	1

1 to 10 of 374Source ClinicalTrials.gov

See all 374 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Riociguat	0	111
Total, all-cause mortality	PDE-5i	4	114
Total, other adverse events	Riociguat	77	111
Total, other adverse events	PDE-5i	72	114
Total, serious adverse events	Riociguat	8	111
Total, serious adverse events	PDE-5i	19	114

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33773120	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Riociguat vs PDE-5i: Number of Participants With Adjudicated Clinical Worsening at Week 24	Trial comparisons
Riociguat vs PDE-5i: deaths from any cause	Trial comparisons
Riociguat vs PDE-5i: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02891850

GET https://conductscience.org/api/trials/v1/NCT02891850/events?page=2

API reference For AI assistants