Adults 18 to 80, any sex, with Hypertension, Pulmonary or Ventricular Dysfunction, Left. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16Primary· 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.
Group
Value
95% CI
Riociguat (Adempas, BAY63-2521) up to 2 mg
-6.1
± 9.68
Riociguat (Adempas, BAY63-2521) up to 1 mg
-0.8
± 8.41
Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg
-4.5
± 7.35
Placebo
-4.0
± 9.00
Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16Secondary· 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.
Group
Value
95% CI
Riociguat (Adempas, BAY63-2521) up to 2 mg
1.98
± 7.084
Riociguat (Adempas, BAY63-2521) up to 1 mg
0.46
± 7.866
Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg
-0.21
± 5.969
Placebo
1.28
± 9.259
Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16Secondary· 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
Group
Value
95% CI
Riociguat (Adempas, BAY63-2521) up to 2 mg
-78.15
± 125.261
Riociguat (Adempas, BAY63-2521) up to 1 mg
-33.05
± 99.322
Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg
-51.44
± 124.107
Placebo
-36.97
± 157.523
Pulmonary Vascular Resistance Index (PVRi) - Change From Baseline to Week 16Secondary· 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
Group
Value
95% CI
Riociguat (Adempas, BAY63-2521) up to 2 mg
-152.60
± 250.366
Riociguat (Adempas, BAY63-2521) up to 1 mg
-61.763
± 202.138
Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg
-91.65
± 237.256
Placebo
-76.47
± 311.693
Systemic Vascular Resistance (SVR) - Change From Baseline to Week 16Secondary· 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
Group
Value
95% CI
Riociguat (Adempas, BAY63-2521) up to 2 mg
-340.44
± 394.87
Riociguat (Adempas, BAY63-2521) up to 1 mg
-118.72
± 369.865
Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg
-67.46
± 315.097
Placebo
-94.37
± 431.049
Systemic Vascular Resistance Index (SVRi) - Change From Baseline to Week 16Secondary· 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
Group
Value
95% CI
Riociguat (Adempas, BAY63-2521) up to 2 mg
-651.98
± 757.617
Riociguat (Adempas, BAY63-2521) up to 1 mg
-217.14
± 742.465
Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg
-100.31
± 612.460
Placebo
-195.11
± 853.927
Transpulmonary Pressure Gradient (TPG) - Change From Baseline to Week 16Secondary· 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
Group
Value
95% CI
Riociguat (Adempas, BAY63-2521) up to 2 mg
-2.16
± 4.795
Riociguat (Adempas, BAY63-2521) up to 1 mg
-1.01
± 5.224
Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg
-1.65
± 4.652
Placebo
-1.37
± 7.001
Pulmonary Capillary Wedge Pressure (PCWP) - Change From Baseline to Week 16Secondary· Baseline and visit 6 (16 weeks)
Pulmonary capillary wedge pressure (PCWP) is a directly measured hemodynamic parameter acquired during a right heart catheterization.
Group
Value
95% CI
Riociguat (Adempas, BAY63-2521) up to 2 mg
-3.93
± 9.381
Riociguat (Adempas, BAY63-2521) up to 1 mg
0.25
± 9.001
Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg
-2.818
± 7.842
Placebo
-2.68
± 7.791
Tricuspid Annular Plane Systolic Excursion (TAPSE) - Change From Baseline to Week 16Secondary· 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.
Group
Value
95% CI
Riociguat (Adempas, BAY63-2521) up to 2 mg
0.584
± 2.344
Riociguat (Adempas, BAY63-2521) up to 1 mg
1.140
± 2.986
Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg
0.304
± 2.109
Placebo
0.393
± 1.586
Systolic Pulmonary Arterial Pressure (PAPsyst) - Change From Baseline to Week 16Secondary· Baseline and visit 6 (16 weeks)
Systolic pulmonary arterial pressure (PAPsyst) is a directly measured hemodynamic parameter acquired during a right heart catheterization.
Group
Value
95% CI
Riociguat (Adempas, BAY63-2521) up to 2 mg
-7.69
± 14.251
Riociguat (Adempas, BAY63-2521) up to 1 mg
-2.89
± 12.333
Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg
-5.86
± 11.589
Placebo
-4.49
± 13.717
Left Ventricular Ejection Fraction (LVEF) - Change From Baseline to Week 16Secondary· Baseline and visit 6 (16 weeks)
The left ventricular ejection fraction work index (LVEF) is a calculated echocardiography parameter. LVEF is derived from the directly measured parameters left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV). These 2 parameters are acquired during a non-invasive echocardiography examination. Formula: LEVF = 100\*(LVEDV - LVESV)/LVEDV
Group
Value
95% CI
Riociguat (Adempas, BAY63-2521) up to 2 mg
6.599
± 43.187
Riociguat (Adempas, BAY63-2521) up to 1 mg
12.659
± 41.769
Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg
5.529
± 48.322
Placebo
11.121
± 42.989
Left Ventricular End-systolic Volume (LVESV) - Change From Baseline to Week 16Secondary· Baseline and visit 6 (16 weeks)
Left ventricular end-systolic volume (LVESV) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.
Group
Value
95% CI
Riociguat (Adempas, BAY63-2521) up to 2 mg
1.805
± 31.735
Riociguat (Adempas, BAY63-2521) up to 1 mg
6.415
± 28.832
Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg
1.507
± 34.033
Placebo
7.295
± 32.311
Adverse events — posted to ClinicalTrials.gov
Time frame: All Adverse Events occurring between the subject has signed the informed consent and 30 days after the definite stop of study medication (over a period approximately 25 months) were reported..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Riociguat (Adempas, BAY63-2521) up to 2 mg
Serious: 23/67 (34%)
Deaths: —
Riociguat (Adempas, BAY63-2521) up to 1 mg
Serious: 7/33 (21%)
Deaths: —
Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg
Serious: 7/32 (22%)
Deaths: —
Placebo
Serious: 18/69 (26%)
Deaths: —
Serious adverse events (60 terms)
Reaction
System
Riociguat (Adempas, BAY63-…
Riociguat (Adempas, BAY63-…
Riociguat (Adempas, BAY63-…
Placebo
Cardiac failure
Cardiac disorders
—
—
—
—
Atrial fibrillation
Cardiac disorders
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—
—
—
Cardiac failure acute
Cardiac disorders
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—
—
—
Cardiac failure congestive
Cardiac disorders
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—
—
—
Ventricular tachycardia
Cardiac disorders
—
—
—
—
Gastroenteritis
Infections and infestations
—
—
—
—
Anaemia
Blood and lymphatic system disorders
—
—
—
—
Cardiac arrest
Cardiac disorders
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—
—
—
Cardiac failure chronic
Cardiac disorders
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—
—
—
Cardiac tamponade
Cardiac disorders
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—
—
—
Coronary artery disease
Cardiac disorders
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—
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—
Right ventricular failure
Cardiac disorders
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—
—
—
Sinus tachycardia
Cardiac disorders
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—
—
—
Ventricular fibrillation
Cardiac disorders
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—
—
—
Abdominal pain upper
Gastrointestinal disorders
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—
—
—
Gastritis erosive
Gastrointestinal disorders
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—
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Gastrointestinal haemorrhage
Gastrointestinal disorders
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—
—
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Intestinal obstruction
Gastrointestinal disorders
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—
—
—
Faecaloma
Gastrointestinal disorders
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—
—
—
Cyst
General disorders
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—
—
—
Hernia
General disorders
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—
—
—
Pyrexia
General disorders
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—
—
—
General physical health deterioration
General disorders
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—
—
—
Medical device complication
General disorders
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—
—
—
Device malfunction
General disorders
—
—
—
—
Other adverse events (155 terms — click to expand)
The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04813926 — A Study to Learn About How Well Riociguat Works, How Safe it is and How it is Used Under Real World Conditions in Patien
· completed
NCT02891850 — Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy
· Phase 4
· completed
NCT02562235 — Riociguat in Children With Pulmonary Arterial Hypertension (PAH)
· Phase 3
· active not recruiting
NCT02545465 — A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic
· completed
NCT02283762 — Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis
· Phase 2
· completed
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Currently open trials in the same condition.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 28 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01065454.