Trial · NCT01065454

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

NCT01065454, Phase 2, Terminated, Bayer; results first posted 2013-12-25

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction. Trials, record NCT01065454. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01065454

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Trial

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

Title: A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction
NCT number: NCT01065454
Status: Terminated
Phases: Phase 2
Enrollment: 202 participants, actual
Lead sponsor: Bayer
Conditions: Hypertension, Pulmonary, Ventricular Dysfunction, Left
Interventions: Riociguat (Adempas, BAY63-2521), Riociguat (Adempas, BAY63-2521), Riociguat (Adempas, BAY63-2521), Placebo
First posted: 2010-02-09
Last updated: 2026-08-20
Other registries' IDs: eudract:2009-015878-35
Results first posted: 2013-12-25
Limitations and caveats: Subjects had advanced disease and were heavily pretreated. Baseline values were not comparable between treatment groups.

Source ClinicalTrials.gov

Registered outcomes26

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

List	Outcome	Time frame	Description
Primary	Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization.
Secondary	Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	The mixed venous oxygen saturation rate (SvO2) is a directly measured hemodynamic parameter. SvO2 is recorded during a right heart catheterization.
Secondary	Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80\*(PAPmean - PCWP)/CO
Secondary	Pulmonary Vascular Resistance Index (PVRi) - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	The pulmonary vascular resistance index (PVRi) is a calculated hemodynamic parameter. PVRi is derived from the pulmonary vascular resistance (PVR) normalized by the body surface area (BSA). Formula: PVRi = 80\(PAPmean - PCWP)\BSA/CO
Secondary	Systemic Vascular Resistance (SVR) - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	The systemic vascular resistance (SVR) is a calculated hemodynamic parameter. SVR is derived from the directly measured parameter mean right atrial pressure (RAPmean) and the calculated parameter mean systemic arterial pressure (SAPmean) divided by the cardiac output (CO). RAPmean is acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: SVR = 80\*(SAPmean - RAPmean)/CO
Secondary	Systemic Vascular Resistance Index (SVRi) - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	The systemic vascular resistance index (SVRi) is a calculated hemodynamic parameter. SVRi is derived from the systemic vascular resistance (SVR) normalized by the body surface area (BSA). Formula: SVRi = 80\(SAPmean - RAPmean)\BSA/CO
Secondary	Transpulmonary Pressure Gradient (TPG) - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	The transpulmonary pressure gradient (TPG) is a calculated hemodynamic parameter. TPG is calculated from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP). These 2 parameters are acquired during a right heart catheterization. Formula: TPG = PAPmean - PCWP
Secondary	Pulmonary Capillary Wedge Pressure (PCWP) - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	Pulmonary capillary wedge pressure (PCWP) is a directly measured hemodynamic parameter acquired during a right heart catheterization.
Secondary	Tricuspid Annular Plane Systolic Excursion (TAPSE) - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	The tricuspid annular plane systolic excursion (TAPSE) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.
Secondary	Systolic Pulmonary Arterial Pressure (PAPsyst) - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	Systolic pulmonary arterial pressure (PAPsyst) is a directly measured hemodynamic parameter acquired during a right heart catheterization.

1 to 10 of 26Source ClinicalTrials.gov

See all 26 registered outcomes

Outcomes26

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF \[safety analysis set\]/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.	mmHg	MEAN
SECONDARY	Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.	Percentage	MEAN
SECONDARY	Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.	dynscm^-5	MEAN
SECONDARY	Pulmonary Vascular Resistance Index (PVRi) - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.	dynscm^-5*m^2	MEAN
SECONDARY	Systemic Vascular Resistance (SVR) - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.	dynscm^-5	MEAN
SECONDARY	Systemic Vascular Resistance Index (SVRi) - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.	dynscm^-5*m^2	MEAN
SECONDARY	Transpulmonary Pressure Gradient (TPG) - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.	mmHg	MEAN
SECONDARY	Pulmonary Capillary Wedge Pressure (PCWP) - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.	mmHg	MEAN
SECONDARY	Tricuspid Annular Plane Systolic Excursion (TAPSE) - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.	mm	MEAN
SECONDARY	Systolic Pulmonary Arterial Pressure (PAPsyst) - Change From Baseline to Week 16	Baseline and visit 6 (16 weeks)	Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.	mmHg	MEAN

1 to 10 of 26Source ClinicalTrials.gov

See all 26 outcomes

Results by group112

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

Outcome	Group	Value	Spread	Units
Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16	Riociguat (Adempas, BAY63-2521) up to 2 mg	-6.1	Standard Deviation 9.68	mmHg
Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16	Riociguat (Adempas, BAY63-2521) up to 1 mg	-0.8	Standard Deviation 8.41	mmHg
Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg	-4.5	Standard Deviation 7.35	mmHg
Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16	Placebo	-4.0	Standard Deviation 9.00	mmHg
Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16	Riociguat (Adempas, BAY63-2521) up to 2 mg	1.98	Standard Deviation 7.084	Percentage
Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16	Riociguat (Adempas, BAY63-2521) up to 1 mg	0.46	Standard Deviation 7.866	Percentage
Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg	-0.21	Standard Deviation 5.969	Percentage
Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16	Placebo	1.28	Standard Deviation 9.259	Percentage
Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16	Riociguat (Adempas, BAY63-2521) up to 2 mg	-78.15	Standard Deviation 125.261	dynscm^-5
Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16	Riociguat (Adempas, BAY63-2521) up to 1 mg	-33.05	Standard Deviation 99.322	dynscm^-5

1 to 10 of 112Source ClinicalTrials.gov

See all 112 results by group

Participant flow28

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

Period	Milestone	Group	Participants
Treatment	STARTED	Riociguat (Adempas, BAY63-2521) up to 2 mg	67
Treatment	STARTED	Riociguat (Adempas, BAY63-2521) up to 1 mg	33
Treatment	STARTED	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg	32
Treatment	STARTED	Placebo	69
Treatment	COMPLETED	Riociguat (Adempas, BAY63-2521) up to 2 mg	54
Treatment	COMPLETED	Riociguat (Adempas, BAY63-2521) up to 1 mg	28
Treatment	COMPLETED	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg	23
Treatment	COMPLETED	Placebo	57
Treatment	NOT COMPLETED	Riociguat (Adempas, BAY63-2521) up to 2 mg	13
Treatment	NOT COMPLETED	Riociguat (Adempas, BAY63-2521) up to 1 mg	5

1 to 10 of 28Source ClinicalTrials.gov

See all 28 participant flow

Adverse events860

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 (Adempas, BAY63-2521) up to 2 mg	2	67	2
other	Anaemia	Blood and lymphatic system disorders	Riociguat (Adempas, BAY63-2521) up to 1 mg	4	33	4
other	Anaemia	Blood and lymphatic system disorders	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg	0	32	0
other	Anaemia	Blood and lymphatic system disorders	Placebo	2	69	3
other	Aortic valve incompetence	Cardiac disorders	Riociguat (Adempas, BAY63-2521) up to 2 mg	0	67	0
other	Aortic valve incompetence	Cardiac disorders	Riociguat (Adempas, BAY63-2521) up to 1 mg	1	33	1
other	Aortic valve incompetence	Cardiac disorders	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg	0	32	0
other	Aortic valve incompetence	Cardiac disorders	Placebo	0	69	0
other	Atrial fibrillation	Cardiac disorders	Riociguat (Adempas, BAY63-2521) up to 2 mg	6	67	7
other	Atrial fibrillation	Cardiac disorders	Riociguat (Adempas, BAY63-2521) up to 1 mg	0	33	0

1 to 10 of 860Source ClinicalTrials.gov

See all 860 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Riociguat (Adempas, BAY63-2521) up to 2 mg
Total, all-cause mortality	Riociguat (Adempas, BAY63-2521) up to 1 mg
Total, all-cause mortality	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Riociguat (Adempas, BAY63-2521) up to 2 mg	57	67
Total, other adverse events	Riociguat (Adempas, BAY63-2521) up to 1 mg	28	33
Total, other adverse events	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg	25	32
Total, other adverse events	Placebo	49	69
Total, serious adverse events	Riociguat (Adempas, BAY63-2521) up to 2 mg	23	67
Total, serious adverse events	Riociguat (Adempas, BAY63-2521) up to 1 mg	7	33

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22719060	RESULT	PubMed
23775260	RESULT	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 comparisons0

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

None in this release.

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.

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