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Evaluation of the Pharmacodynamic Effect of the Combination of Sildenafil and Riociguat on Blood Pressure and Other Safety Parameters. (PATENT PLUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01179334
Recruitment Status : Completed
First Posted : August 11, 2010
Results First Posted : December 25, 2013
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pulmonary Hypertension
Interventions Drug: Riociguat (Adempas, BAY63-2521)
Drug: Placebo
Drug: Sildenafil
Enrollment 18
Recruitment Details Only participants with symptomatic Pulmonary arterial hypertension (PAH) could participate in this study. Subjects must be on pre-treatment with sildenafil at a dose of 20 mg three times daily (tid) (20 or 25 mg tid in New Zealand) for at least 90 days.
Pre-assignment Details 24 subjects were enrolled in 11 study centers in 5 European countries. Six of the 24 subjects were screened but not randomized (screen failure [6]). 18 of the 24 participants were randomized. All of the 18 randomized participants received study medication.
Arm/Group Title Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT Placebo
Hide Arm/Group Description Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions. Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Period Title: Treatment Period
Started 12 6
Participants Received Treatment 12 6
Completed 11 6
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Period Title: Long-term Extension (LTE) Period
Started 11 6
Completed 0 [1] 0 [1]
Not Completed 11 6
Reason Not Completed
Study terminated by sponsor             6             2
Death             3             0
Adverse Event             2             4
[1]
LTE phase was terminated by sponsor
Arm/Group Title Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT Placebo Total
Hide Arm/Group Description Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions. Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions. Total of all reporting groups
Overall Number of Baseline Participants 12 6 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 6 participants 18 participants
58.3  (10.7) 61.3  (10.0) 59.3  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 6 participants 18 participants
Female
8
  66.7%
4
  66.7%
12
  66.7%
Male
4
  33.3%
2
  33.3%
6
  33.3%
1.Primary Outcome
Title Maximum Change From Baseline in Supine Systolic Blood Pressure (SBP) Within 4 Hours Post-dose at Visit 6 (Week 12)
Hide Description Systolic blood pressure (SBP) was measured as standard vital sign parameter. Range allowed in this study: <= 180 mmHg. In addition, SBP must be >=95 mmHg in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent SBP measurements in that profile) within 4 hours post-dose. Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.
Time Frame Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
pharmacodynamic(s) (PD) analysis set
Arm/Group Title Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT Placebo
Hide Arm/Group Description:
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Overall Number of Participants Analyzed 10 5
Mean (Standard Deviation)
Unit of Measure: mmHg
-20.70  (17.97) -20.20  (12.91)
2.Secondary Outcome
Title Maximum Change From Baseline in Standing Systolic Blood Pressure (SBP) Within 4 Hours Post-dose at Visit 6 (Week 12)
Hide Description Systolic blood pressure (SBP) was measured as standard vital sign parameter. Range allowed in this study: <= 180 mmHg. In addition, SBP must be >=95 mmHg in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent SBP measurements in that profile) within 4 hours post-dose. Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.
Time Frame Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set
Arm/Group Title Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT Placebo
Hide Arm/Group Description:
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Overall Number of Participants Analyzed 10 5
Mean (Standard Deviation)
Unit of Measure: mmHg
-18.00  (16.50) -16.80  (10.62)
3.Secondary Outcome
Title Maximum Change From Baseline in Supine Diastolic Blood Pressure (DBP) Within 4 Hours Post-dose at Visit 6 (Week 12)
Hide Description Diastolic blood pressure (DBP) was measured as standard vital sign parameter. Range allowed in this study: <= 110 mmHg. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent DBP measurements in that profile) within 4 hours post-dose. Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.
Time Frame Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set
Arm/Group Title Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT Placebo
Hide Arm/Group Description:
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Overall Number of Participants Analyzed 10 5
Mean (Standard Deviation)
Unit of Measure: mmHg
-13.70  (11.72) -13.80  (12.85)
4.Secondary Outcome
Title Maximum Change From Baseline in Standing Diastolic Blood Pressure (DBP) Within 4 Hours Post-dose at Visit 6 (Week 12)
Hide Description Diastolic blood pressure (DBP) was measured as standard vital sign parameter. Range allowed in this study: <= 110 mmHg. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent DBP measurements in that profile) within 4 hours post-dose. Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.
Time Frame Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set
Arm/Group Title Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT Placebo
Hide Arm/Group Description:
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Overall Number of Participants Analyzed 10 5
Mean (Standard Deviation)
Unit of Measure: mmHg
-14.40  (10.59) -14.20  (10.03)
5.Secondary Outcome
Title Maximum Change From Baseline in Supine Heart Rate (HR) Within 4 Hours Post-dose at Visit 6 (Week 12)
Hide Description Heart rate (HR) was measured as standard vital sign parameter. Range allowed in this study: <= 105 beats per minute (bpm) in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum increase from baseline (or zero if baseline was higher than all subsequent HR measurements in that profile) within 4 hours post-dose. Baseline was the last HR recorded at and within 30 minutes before intake of study drug.
Time Frame Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set
Arm/Group Title Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT Placebo
Hide Arm/Group Description:
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Overall Number of Participants Analyzed 10 5
Mean (Standard Deviation)
Unit of Measure: Beats/min
5.90  (7.14) 9.60  (5.50)
6.Secondary Outcome
Title Maximum Change From Baseline in Standing Heart Rate (HR) Within 4 Hours Post-dose at Visit 6 (Week 12)
Hide Description Heart rate (HR) was measured as standard vital sign parameter. Range allowed in this study: <= 105 beats per minute (bpm) in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum increase from baseline (or zero if baseline was higher than all subsequent HR measurements in that profile) within 4 hours post-dose. Baseline was the last HR recorded at and within 30 minutes before intake of study drug.
Time Frame Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set
Arm/Group Title Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT Placebo
Hide Arm/Group Description:
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Overall Number of Participants Analyzed 10 5
Mean (Standard Deviation)
Unit of Measure: Beats/min
6.50  (7.17) 10.40  (6.54)
7.Secondary Outcome
Title Area Under Effect Curve (AUEC) of Supine SBP Within 4 Hours Post-dose at Visit 6 (Week 12)
Hide Description The area under the effect curve (AUEC) at each visit of supine SBP describes an average within-subject change in SBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.
Time Frame Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set
Arm/Group Title Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT Placebo
Hide Arm/Group Description:
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Overall Number of Participants Analyzed 10 5
Mean (Standard Deviation)
Unit of Measure: mmHg*h
46.32  (53.57) 42.44  (28.19)
8.Secondary Outcome
Title Area Under Effect Curve (AUEC) of Standing SBP Within 4 Hours Post-dose at Visit 6 (Week 12)
Hide Description The area under effect curve (AUEC) at each visit of standing SBP describes an average within-subject change in SBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.
Time Frame Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set
Arm/Group Title Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT Placebo
Hide Arm/Group Description:
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Overall Number of Participants Analyzed 10 5
Mean (Standard Deviation)
Unit of Measure: mmHg*h
38.96  (47.51) 30.41  (33.35)
9.Secondary Outcome
Title Area Under Effect Curve (AUEC) of Supine DBP Within 4 Hours Post-dose at Visit 6 (Week 12)
Hide Description The area under effect curve (AUEC) at each visit of supine DBP describes an average within-subject change in DBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.
Time Frame Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set
Arm/Group Title Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT Placebo
Hide Arm/Group Description:
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Overall Number of Participants Analyzed 10 5
Mean (Standard Deviation)
Unit of Measure: mmHg*h
30.79  (35.66) 32.92  (35.68)
10.Secondary Outcome
Title Area Under Effect Curve (AUEC) of Standing DBP Within 4 Hours Post-dose at Visit 6 (Week 12)
Hide Description The area under effect curve (AUEC) at each visit of standing DBP describes an average within-subject change in DBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.
Time Frame Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set
Arm/Group Title Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT Placebo
Hide Arm/Group Description:
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Overall Number of Participants Analyzed 10 5
Mean (Standard Deviation)
Unit of Measure: mmHg*h
32.50  (34.04) 24.20  (22.54)
11.Secondary Outcome
Title Area Under Effect Curve (AUEC) of Supine HR Within 4 Hours Post-dose at Visit 6 (Week 12)
Hide Description The area under effect curve (AUEC) at each visit of supine HR describes an average within-subject change in HR from baseline over a time-period of 4 hours post-dose (Note that the area only takes values above the individual baseline for the respective visit into account. The area that would result from a decrease from baseline is not taken into account for the calculation of the area). Baseline was the last HR recorded at and within 30 minutes before intake of study drug.
Time Frame Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set
Arm/Group Title Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT Placebo
Hide Arm/Group Description:
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Overall Number of Participants Analyzed 10 5
Mean (Standard Deviation)
Unit of Measure: Beats/min*h
9.86  (13.08) 18.85  (14.86)
12.Secondary Outcome
Title Area Under Effect Curve (AUEC) of Standing HR Within 4 Hours Post-dose at Visit 6 (Week 12)
Hide Description The area under effect curve (AUEC) at each visit of standing HR describes an average within-subject increase in HR from baseline over a time-period of 4 hours post-dose (Note that the area only takes values above the individual baseline for the respective visit into account. The area that would result from a decrease from baseline is not taken into account for the calculation of the area). Baseline was the last HR recorded at and within 30 minutes before intake of study drug.
Time Frame Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
PD analysis set
Arm/Group Title Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT Placebo
Hide Arm/Group Description:
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Overall Number of Participants Analyzed 10 5
Mean (Standard Deviation)
Unit of Measure: Beats/min*h
13.18  (15.11) 15.69  (11.81)
Time Frame Adverse event data were collected after signing the informed consent until 2 days after end of treatment with the study medication.
Adverse Event Reporting Description Participants completing the main 12-week study phase were allowed to enter a long-term extension phase receiving individual titrated Riociguat at their optimal dose. Long-term extension phase was planned to last until regulatory approval of riociguat but was prematurely terminated by the sponsor.
 
Arm/Group Title Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT Placebo
Hide Arm/Group Description Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions. Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
All-Cause Mortality
Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   7/12 (58.33%)   2/6 (33.33%) 
Cardiac disorders     
Angina pectoris * 1  0/12 (0.00%)  1/6 (16.67%) 
Atrial fibrillation * 1  1/12 (8.33%)  0/6 (0.00%) 
Cardiac arrest * 1  1/12 (8.33%)  0/6 (0.00%) 
Right ventricular failure * 1  1/12 (8.33%)  0/6 (0.00%) 
Acute right ventricular failure * 1  1/12 (8.33%)  0/6 (0.00%) 
Chronic right ventricular failure * 1  1/12 (8.33%)  0/6 (0.00%) 
Gastrointestinal disorders     
Colitis * 1  1/12 (8.33%)  0/6 (0.00%) 
Constipation * 1  1/12 (8.33%)  0/6 (0.00%) 
Infections and infestations     
Erysipelas * 1  1/12 (8.33%)  0/6 (0.00%) 
Pneumonia * 1  1/12 (8.33%)  0/6 (0.00%) 
Injury, poisoning and procedural complications     
Joint dislocation * 1  1/12 (8.33%)  0/6 (0.00%) 
Subdural haematoma * 1  1/12 (8.33%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion * 1  1/12 (8.33%)  0/6 (0.00%) 
Nervous system disorders     
Loss of consciousness * 1  1/12 (8.33%)  0/6 (0.00%) 
Syncope * 1  1/12 (8.33%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure * 1  1/12 (8.33%)  0/6 (0.00%) 
Hypoxia * 1  1/12 (8.33%)  0/6 (0.00%) 
Interstitial lung disease * 1  1/12 (8.33%)  0/6 (0.00%) 
Vascular disorders     
Hypotension * 1  1/12 (8.33%)  1/6 (16.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   12/12 (100.00%)   6/6 (100.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  3/12 (25.00%)  1/6 (16.67%) 
Lymphadenopathy * 1  1/12 (8.33%)  0/6 (0.00%) 
Cardiac disorders     
Atrial fibrillation * 1  1/12 (8.33%)  0/6 (0.00%) 
Palpitations * 1  0/12 (0.00%)  2/6 (33.33%) 
Chronic right ventricular failure * 1  1/12 (8.33%)  0/6 (0.00%) 
Ear and labyrinth disorders     
Vertigo * 1  2/12 (16.67%)  0/6 (0.00%) 
Endocrine disorders     
Hypothyroidism * 1  1/12 (8.33%)  0/6 (0.00%) 
Eye disorders     
Eye swelling * 1  0/12 (0.00%)  1/6 (16.67%) 
Eyelid oedema * 1  1/12 (8.33%)  0/6 (0.00%) 
Vision blurred * 1  1/12 (8.33%)  1/6 (16.67%) 
Gastrointestinal disorders     
Abdominal pain * 1  2/12 (16.67%)  1/6 (16.67%) 
Abdominal pain upper * 1  0/12 (0.00%)  1/6 (16.67%) 
Anal fissure * 1  1/12 (8.33%)  0/6 (0.00%) 
Constipation * 1  1/12 (8.33%)  0/6 (0.00%) 
Diarrhoea * 1  3/12 (25.00%)  1/6 (16.67%) 
Dry mouth * 1  1/12 (8.33%)  0/6 (0.00%) 
Dyspepsia * 1  2/12 (16.67%)  3/6 (50.00%) 
Flatulence * 1  1/12 (8.33%)  0/6 (0.00%) 
Gastritis * 1  0/12 (0.00%)  1/6 (16.67%) 
Gastrooesophageal reflux disease * 1  1/12 (8.33%)  1/6 (16.67%) 
Hiatus hernia * 1  0/12 (0.00%)  1/6 (16.67%) 
Mouth ulceration * 1  1/12 (8.33%)  0/6 (0.00%) 
Nausea * 1  0/12 (0.00%)  1/6 (16.67%) 
Rectal haemorrhage * 1  1/12 (8.33%)  0/6 (0.00%) 
Tongue ulceration * 1  1/12 (8.33%)  0/6 (0.00%) 
Vomiting * 1  2/12 (16.67%)  2/6 (33.33%) 
Epigastric discomfort * 1  0/12 (0.00%)  1/6 (16.67%) 
Regurgitation * 1  1/12 (8.33%)  0/6 (0.00%) 
General disorders     
Asthenia * 1  2/12 (16.67%)  0/6 (0.00%) 
Chest discomfort * 1  1/12 (8.33%)  0/6 (0.00%) 
Chills * 1  1/12 (8.33%)  0/6 (0.00%) 
Fatigue * 1  3/12 (25.00%)  0/6 (0.00%) 
Oedema * 1  2/12 (16.67%)  1/6 (16.67%) 
Oedema peripheral * 1  7/12 (58.33%)  0/6 (0.00%) 
Pyrexia * 1  2/12 (16.67%)  1/6 (16.67%) 
Inflammation * 1  1/12 (8.33%)  0/6 (0.00%) 
Infections and infestations     
Bronchitis * 1  1/12 (8.33%)  0/6 (0.00%) 
Erysipelas * 1  2/12 (16.67%)  0/6 (0.00%) 
Gastroenteritis * 1  1/12 (8.33%)  0/6 (0.00%) 
Influenza * 1  0/12 (0.00%)  1/6 (16.67%) 
Nasopharyngitis * 1  3/12 (25.00%)  0/6 (0.00%) 
Periodontitis * 1  1/12 (8.33%)  0/6 (0.00%) 
Sialoadenitis * 1  1/12 (8.33%)  0/6 (0.00%) 
Pharyngotonsillitis * 1  1/12 (8.33%)  0/6 (0.00%) 
Peritonitis bacterial * 1  1/12 (8.33%)  0/6 (0.00%) 
Oral herpes * 1  1/12 (8.33%)  0/6 (0.00%) 
Injury, poisoning and procedural complications     
Fall * 1  1/12 (8.33%)  0/6 (0.00%) 
Road traffic accident * 1  0/12 (0.00%)  1/6 (16.67%) 
Subcutaneous haematoma * 1  1/12 (8.33%)  0/6 (0.00%) 
Contusion * 1  0/12 (0.00%)  1/6 (16.67%) 
Meniscus injury * 1  1/12 (8.33%)  0/6 (0.00%) 
Investigations     
Alanine aminotransferase increased * 1  1/12 (8.33%)  1/6 (16.67%) 
Alpha 1 foetoprotein increased * 1  1/12 (8.33%)  0/6 (0.00%) 
Aspartate aminotransferase increased * 1  1/12 (8.33%)  1/6 (16.67%) 
Blood bilirubin increased * 1  1/12 (8.33%)  0/6 (0.00%) 
Blood cholinesterase decreased * 1  1/12 (8.33%)  0/6 (0.00%) 
Blood creatine phosphokinase increased * 1  1/12 (8.33%)  0/6 (0.00%) 
Blood creatinine increased * 1  1/12 (8.33%)  0/6 (0.00%) 
Blood lactate dehydrogenase increased * 1  1/12 (8.33%)  0/6 (0.00%) 
Blood potassium decreased * 1  0/12 (0.00%)  2/6 (33.33%) 
Blood pressure systolic decreased * 1  1/12 (8.33%)  0/6 (0.00%) 
Electrocardiogram QT prolonged * 1  0/12 (0.00%)  1/6 (16.67%) 
Gamma-glutamyltransferase increased * 1  0/12 (0.00%)  1/6 (16.67%) 
Glomerular filtration rate decreased * 1  1/12 (8.33%)  0/6 (0.00%) 
Lymphocyte count decreased * 1  1/12 (8.33%)  0/6 (0.00%) 
Neutrophil count increased * 1  1/12 (8.33%)  0/6 (0.00%) 
Weight decreased * 1  0/12 (0.00%)  1/6 (16.67%) 
Glutamate dehydrogenase increased * 1  1/12 (8.33%)  0/6 (0.00%) 
Blood alkaline phosphatase increased * 1  1/12 (8.33%)  0/6 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycaemia * 1  1/12 (8.33%)  0/6 (0.00%) 
Hypokalaemia * 1  4/12 (33.33%)  0/6 (0.00%) 
Hypomagnesaemia * 1  1/12 (8.33%)  0/6 (0.00%) 
Hyponatraemia * 1  1/12 (8.33%)  0/6 (0.00%) 
Iron deficiency * 1  1/12 (8.33%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/12 (8.33%)  0/6 (0.00%) 
Arthritis * 1  1/12 (8.33%)  0/6 (0.00%) 
Back pain * 1  2/12 (16.67%)  1/6 (16.67%) 
Joint swelling * 1  1/12 (8.33%)  0/6 (0.00%) 
Muscle spasms * 1  1/12 (8.33%)  0/6 (0.00%) 
Musculoskeletal pain * 1  0/12 (0.00%)  1/6 (16.67%) 
Myalgia * 1  1/12 (8.33%)  1/6 (16.67%) 
Neck pain * 1  0/12 (0.00%)  1/6 (16.67%) 
Pain in extremity * 1  1/12 (8.33%)  0/6 (0.00%) 
Intervertebral disc protrusion * 1  1/12 (8.33%)  0/6 (0.00%) 
Nervous system disorders     
Dizziness * 1  4/12 (33.33%)  2/6 (33.33%) 
Headache * 1  3/12 (25.00%)  3/6 (50.00%) 
Sciatica * 1  0/12 (0.00%)  1/6 (16.67%) 
Psychiatric disorders     
Insomnia * 1  1/12 (8.33%)  0/6 (0.00%) 
Renal and urinary disorders     
Renal failure * 1  1/12 (8.33%)  0/6 (0.00%) 
Renal failure chronic * 1  1/12 (8.33%)  0/6 (0.00%) 
Reproductive system and breast disorders     
Menorrhagia * 1  1/12 (8.33%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchitis chronic * 1  1/12 (8.33%)  0/6 (0.00%) 
Bronchospasm * 1  1/12 (8.33%)  0/6 (0.00%) 
Chronic obstructive pulmonary disease * 1  1/12 (8.33%)  0/6 (0.00%) 
Cough * 1  3/12 (25.00%)  1/6 (16.67%) 
Dyspnoea * 1  1/12 (8.33%)  0/6 (0.00%) 
Epistaxis * 1  0/12 (0.00%)  1/6 (16.67%) 
Hypoxia * 1  1/12 (8.33%)  0/6 (0.00%) 
Nasal congestion * 1  1/12 (8.33%)  0/6 (0.00%) 
Nasal obstruction * 1  0/12 (0.00%)  1/6 (16.67%) 
Pleural effusion * 1  1/12 (8.33%)  0/6 (0.00%) 
Pulmonary fibrosis * 1  1/12 (8.33%)  0/6 (0.00%) 
Sleep apnoea syndrome * 1  1/12 (8.33%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders     
Night sweats * 1  1/12 (8.33%)  0/6 (0.00%) 
Pruritus * 1  1/12 (8.33%)  1/6 (16.67%) 
Skin ulcer * 1  1/12 (8.33%)  0/6 (0.00%) 
Surgical and medical procedures     
Cataract operation * 1  1/12 (8.33%)  0/6 (0.00%) 
Vascular disorders     
Capillary fragility * 1  0/12 (0.00%)  1/6 (16.67%) 
Hypertension * 1  1/12 (8.33%)  0/6 (0.00%) 
Hypotension * 1  6/12 (50.00%)  2/6 (33.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (16.0)
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The embargo can be up to 6 months (equal to the 180 days), moreover if it is necessary the embargo period can be prolonged to expiry of priority year.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Bayer
EMail: clinical-trials-contact@bayerhealthcare.com
Publications of Results:
Galie N, Muller K, Scalise AV, Grunig E. PATENT PLUS: a blinded, randomised and extension study of riociguat plus sildenafil in pulmonary arterial hypertension. Eur Respir J. 2015 May;45(5):1314-22. doi: 10.1183/09031936.00105914. Epub 2015 Feb 5.
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01179334    
Other Study ID Numbers: 15096
2010-018863-40 ( EudraCT Number )
First Submitted: August 10, 2010
First Posted: August 11, 2010
Results First Submitted: November 6, 2013
Results First Posted: December 25, 2013
Last Update Posted: August 29, 2016