Trial · NCT02138825

Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP)

NCT02138825, Phase 2, Terminated, Bayer; results first posted 2017-06-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP). Trials, record NCT02138825. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02138825

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Trial

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

Title: Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP)
NCT number: NCT02138825
Status: Terminated
Phases: Phase 2
Enrollment: 147 participants, actual
Lead sponsor: Bayer
Conditions: Idiopathic Interstitial Pneumonias / Hypertension,Pulmonary
Interventions: Riociguat (Adempas, BAY63-2521), Placebo
First posted: 2014-05-15
Last updated: 2017-12-04
Other registries' IDs: eudract:2010-024332-42
Results first posted: 2017-06-05
Limitations and caveats: The study was prematurely terminated following a recommendation from the independent Data Monitoring Committee, as patients receiving Riociguat showed an increased risk of mortality and serious adverse events as compared to patients receiving Placebo

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Mean Change in 6 Minute Walking Distance (6MWD) From Baseline to Week 26	Baseline to 26 weeks	The 6MWD test is designed to evaluate a patient's exercise capacity while performing an everyday activity.
Secondary	Number of Participants With Clinical Worsening	From baseline to week 26	The combined endpoint "time to clinical worsening", made up of the following components, defined by the first occurrence: all-cause mortality; need for hospitalization due to worsening cardiopulmonary (CP) status, attributable to progression of disease (including but not limited to increased shortness of breath or increased leg swelling); \>15% decrease in the 6MWD test; worsening of WHO functional class.

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	Mean Change in 6 Minute Walking Distance (6MWD) From Baseline to Week 26	Baseline to 26 weeks	Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication.	Meter	MEAN
SECONDARY	Number of Participants With Clinical Worsening	From baseline to week 26	Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication.	Participants	NUMBER
POST_HOC	Number of Deaths Per Study Phase for Riociguat Group	From start of treatment to end of study	Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication.	Participants	NUMBER
POST_HOC	Number of Deaths Per Study Phase for Placebo Group	From start of treatment to end of study	Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication.	Participants	NUMBER
POST_HOC	Number of Serious Adverse Events During Safety Follow-up Phase	From start of safety follow-up phase until end of study	Safety analysis set: participants randomized and received at least one dose of study medication.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group21

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

Outcome	Group	Category	Value	Spread	Units
Mean Change in 6 Minute Walking Distance (6MWD) From Baseline to Week 26	Riociguat (Adempas, BAY63-2521)		3.63	Standard Deviation 60.80	Meter
Mean Change in 6 Minute Walking Distance (6MWD) From Baseline to Week 26	Placebo		-15.94	Standard Deviation 63.70	Meter
Number of Participants With Clinical Worsening	Riociguat (Adempas, BAY63-2521)	No clinical event	39		Participants
Number of Participants With Clinical Worsening	Placebo	No clinical event	38		Participants
Number of Participants With Clinical Worsening	Riociguat (Adempas, BAY63-2521)	>15% decrease in 6MWD	9		Participants
Number of Participants With Clinical Worsening	Placebo	>15% decrease in 6MWD	17		Participants
Number of Participants With Clinical Worsening	Riociguat (Adempas, BAY63-2521)	All-cause mortality	1		Participants
Number of Participants With Clinical Worsening	Placebo	All-cause mortality	0		Participants
Number of Participants With Clinical Worsening	Riociguat (Adempas, BAY63-2521)	Hospitalization due to worsening CP status	15		Participants
Number of Participants With Clinical Worsening	Placebo	Hospitalization due to worsening CP status	7		Participants

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Main Study Treatment	STARTED	Riociguat (Adempas, BAY63-2521)	73
Main Study Treatment	STARTED	Placebo	74
Main Study Treatment	COMPLETED	Riociguat (Adempas, BAY63-2521)	33
Main Study Treatment	COMPLETED	Placebo	39
Main Study Treatment	NOT COMPLETED	Riociguat (Adempas, BAY63-2521)	40
Main Study Treatment	NOT COMPLETED	Placebo	35
Long-term Extension	STARTED	Riociguat (Adempas, BAY63-2521)	32
Long-term Extension	STARTED	Placebo	38
Long-term Extension	COMPLETED	Riociguat (Adempas, BAY63-2521)	0
Long-term Extension	COMPLETED	Placebo	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events496

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
other	Right ventricular failure	Cardiac disorders	Riociguat up to 2.5 mg Tid	4	73
other	Right ventricular failure	Cardiac disorders	Placebo	0	74
other	Right ventricular failure	Cardiac disorders	Riociguat-Riociguat Transition	2	32
other	Right ventricular failure	Cardiac disorders	Placebo-Riociguat Transition	1	38
other	Abdominal pain upper	Gastrointestinal disorders	Riociguat up to 2.5 mg Tid	3	73
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	2	74
other	Abdominal pain upper	Gastrointestinal disorders	Riociguat-Riociguat Transition	2	32
other	Abdominal pain upper	Gastrointestinal disorders	Placebo-Riociguat Transition	0	38
other	Constipation	Gastrointestinal disorders	Riociguat up to 2.5 mg Tid	4	73
other	Constipation	Gastrointestinal disorders	Placebo	2	74

1 to 10 of 496Source ClinicalTrials.gov

See all 496 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Riociguat up to 2.5 mg Tid
Total, all-cause mortality	Placebo
Total, all-cause mortality	Riociguat-Riociguat Transition
Total, all-cause mortality	Placebo-Riociguat Transition
Total, other adverse events	Riociguat up to 2.5 mg Tid	54	73
Total, other adverse events	Placebo	52	74
Total, other adverse events	Riociguat-Riociguat Transition	26	32
Total, other adverse events	Placebo-Riociguat Transition	32	38
Total, serious adverse events	Riociguat up to 2.5 mg Tid	27	73
Total, serious adverse events	Placebo	17	74

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31416769	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 comparisons1

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

Comparison
Riociguat up to 2.5 mg Tid vs Placebo: Number of Serious Adverse Events During Safety Follow-up Phase

Source 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.

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