Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure With Reduced Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-REDUCED)
Study Details
Study Description
Brief Summary
Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Vericiguat (BAY1021189) (10 mg) 2.5 mg orally once daily for 2 weeks, up-titration to 5 mg orally once daily for 2 weeks, up-titration to 10 mg orally once daily for 8 weeks |
Drug: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Drug: Vericiguat (BAY1021189) (5 mg)
5 mg BAY1021189 tablets
|
Experimental: Vericiguat (BAY1021189) (5 mg) 2.5 mg orally once daily for 2 weeks, then 5 mg orally once daily for 10 weeks (with sham titration) |
Drug: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
Drug: Vericiguat (BAY1021189) (5 mg)
5 mg BAY1021189 tablets
|
Experimental: Vericiguat (BAY1021189) (2.5 mg) 2.5 mg orally once daily for 12 weeks (with sham titrations) |
Drug: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
|
Experimental: Vericiguat (BAY1021189) (1.25 mg) 1.25 mg orally once daily for 12 weeks (with sham titrations) |
Drug: Vericiguat (BAY1021189) (1.25 mg)
1.25 mg BAY1021189 tablets
|
Placebo Comparator: Placebo Orally once daily for 12 weeks (with sham titrations) |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Log-Transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) to Week 12 [Baseline, Week 12]
Log-Transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) is a circulating plasma biomarker of cardiovascular function and prognosis in heart failure.
Other Outcome Measures
- Changes in Heart Function as Measured by Echocardiography, Left Ventricular End-Diastolic Volume (LVEDV), and Left Ventricular End-Systolic Volume (LVESV) From Baseline to Week 12 [Baseline, Week 12]
Left Ventricular End-Diastolic Volume (LVEDV) and Left ventricular end-systolic volume (LVESV) are measured echocardiography parameter. These are acquired during a non-invasive echocardiography examination.
- Changes in Heart Function as Measured by Echocardiography, Left Ventricular Ejection Fraction (LVEF), From Baseline to Week 12 [Baseline, Week 12]
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 noninvasive echocardiography examination. Formula: LVEF = 100*(LVEDV - LVESV)/LVEDV.
- Change From Baseline in Systolic and Diastolic Blood Pressure to Week 12 [Baseline, Week 12]
Blood pressure was measured by monitor measurements after 10 minutes resting in a supine position (3 measurements taken approximately 2 minutes apart).The changes in blood pressure were recorded and the mean of the three measurements was analyzed.
- Change From Baseline in Heart Rate to Week 12 [Baseline, Week 12]
Heart rate was measured after 10 minutes resting in a supine position (3 measurements taken approximately 2 minutes apart). The changes in heart rate were recorded and the mean of the three measurements was analyzed.
- Number of Subjects With Clinical Events (Heart Failure [HF] Hospitalization and Cardio-Vascular [CV] Mortality) [Baseline until 16 weeks]
Clinical events (heart failure and mortality) were analyzed as CV death, and HF hospitalization at specified time points.
- Number of Subjects With Implantable Cardioverter Defibrillators Cardiac Resynchronization Therapy With Defibrillation (ICD/CRT-D) Therapy [Baseline upto 16 weeks]
ICD / CRT with defibrillation therapy (CRT-D) included previous appropriate interventions such as shocks or anti-tachycardic pacing (ATP) when diagnostic of sustained ventricular tachycardias in pre defined rapid zone.
- Number of Subjects With Treatment-Emergent Adverse Events [From the start of study treatment upto 5 days after the last dose of study drug]
An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; and another medically important serious event as judged by the investigator. AEs are considered to be treatment-emergent if they have started or worsened after first application of study drug up to 5 days after end of treatment with study drug.
- Change in Biomarkers From Baseline to Week 12: Osteopontin (ng/mL) [Baseline, Week 12]
- Change in Biomarkers From Baseline to Week 12: TIMP-4 (pg/mL) [Baseline, Week 12]
TIMP-4: tissue inhibitor of matrix metalloproteinases 4
- Change in Biomarkers From Baseline to Week 12: cGMP (Pmol/mL) [Baseline, Week 12]
cGMP: cyclic guanosine monophosphate
- Change in Biomarkers From Baseline to Week 12: PIIINP (mcg/L) [Baseline, Week 12]
PIIINP: pro-collagen III N-terminal peptide
- Change in Biomarkers From Baseline to Week 12: GDF-15 (pg/mL) [Baseline, Week 12]
GDF-15: growth differentiation factor 15
- Change in Biomarkers From Baseline to Week 12: ST2 (pg/mL) [Baseline, Week 12]
ST2: suppression of tumorigenicity 2
- Change in Biomarkers From Baseline to Week 12: Gal-3 (μg/mL) [Baseline, Week 12]
Gal-3: Galectin-3
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization
-
Left ventricular ejection fraction (LVEF) <45% by echocardiography at randomization
Exclusion Criteria:
- Intravenous inotropes at any time after hospitalization
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Fountain Valley | California | United States | 92708 | |
2 | Wilmington | Delaware | United States | 19803 | |
3 | Fort Lauderdale | Florida | United States | 33308 | |
4 | Jacksonville | Florida | United States | 32209 | |
5 | Naples | Florida | United States | 34102 | |
6 | Atlanta | Georgia | United States | 30342 | |
7 | Macon | Georgia | United States | 31201 | |
8 | New Orleans | Louisiana | United States | 70112-1396 | |
9 | Detroit | Michigan | United States | 48202 | |
10 | Minneapolis | Minnesota | United States | 55422 | |
11 | Jackson | Mississippi | United States | 39216-4505 | |
12 | Buffalo | New York | United States | 14215 | |
13 | Columbus | Ohio | United States | 43210 | |
14 | Fairfield | Ohio | United States | 45014 | |
15 | Charleston | South Carolina | United States | 29425 | |
16 | Germantown | Tennessee | United States | 38138 | |
17 | Nashville | Tennessee | United States | 37232-8802 | |
18 | Milwaukee | Wisconsin | United States | 53215 | |
19 | Darlinghurst | New South Wales | Australia | 2010 | |
20 | Hobart | Tasmania | Australia | 7000 | |
21 | Prahran | Victoria | Australia | 3181 | |
22 | St. Pölten | Niederösterreich | Austria | 3100 | |
23 | Linz | Oberösterreich | Austria | 4020 | |
24 | Graz | Steiermark | Austria | 8036 | |
25 | Salzburg | Austria | 5020 | ||
26 | Wien | Austria | 1220 | ||
27 | Brugge | Belgium | 8000 | ||
28 | Bruxelles - Brussel | Belgium | 1200 | ||
29 | Gent | Belgium | 9000 | ||
30 | Gilly | Belgium | 6060 | ||
31 | HUY | Belgium | 4500 | ||
32 | Mechelen | Belgium | 2800 | ||
33 | MOL | Belgium | 2400 | ||
34 | Roeselare | Belgium | 8800 | ||
35 | Sofia | Bulgaria | 1202 | ||
36 | Sofia | Bulgaria | 1233 | ||
37 | Sofia | Bulgaria | 1309 | ||
38 | Sofia | Bulgaria | 1527 | ||
39 | Stara Zagora | Bulgaria | 6000 | ||
40 | Toronto | Ontario | Canada | M5B 1W8 | |
41 | Montreal | Quebec | Canada | H1T 1C8 | |
42 | Montreal | Quebec | Canada | H2W 1T8 | |
43 | Saint-Jean-sur-Richelieu | Quebec | Canada | J3A 1C3 | |
44 | Sherbrooke | Quebec | Canada | J1G 2E8 | |
45 | Quebec | Canada | G1V 4G5 | ||
46 | Hradec kralove | Czechia | 500 05 | ||
47 | Kromeriz | Czechia | 767 01 | ||
48 | Fakultni nemocnice Ostrava | Ostrava | Czechia | 708 52 | |
49 | Praha 10 | Czechia | 10034 | ||
50 | Praha 2 | Czechia | 12808 | ||
51 | Praha 4 | Czechia | 140 21 | ||
52 | Praha 6 | Czechia | 169 02 | ||
53 | Slany | Czechia | 274 01 | ||
54 | Aalborg | Denmark | 9000 | ||
55 | Aarhus N | Denmark | 8200 | ||
56 | Hellerup | Denmark | DK-2900 | ||
57 | Viborg | Denmark | 8800 | ||
58 | BRON Cedex | France | 69677 | ||
59 | La Tronche | France | 38700 | ||
60 | Lille Cedex | France | 59037 | ||
61 | Paris Cedex 15 | France | 75908 | ||
62 | Pessac | France | 33604 | ||
63 | Rouen | France | 76031 | ||
64 | München | Bayern | Germany | 80331 | |
65 | Bad Homburg | Hessen | Germany | 61348 | |
66 | Frankfurt | Hessen | Germany | 60596 | |
67 | Greifswald | Mecklenburg-Vorpommern | Germany | 17475 | |
68 | Hannover | Niedersachsen | Germany | 30625 | |
69 | Köln | Nordrhein-Westfalen | Germany | 50924 | |
70 | Münster | Nordrhein-Westfalen | Germany | 48149 | |
71 | Homburg | Saarland | Germany | 66424 | |
72 | Erfurt | Thüringen | Germany | 99089 | |
73 | Hamburg | Germany | 20246 | ||
74 | Athens | Greece | 11527 | ||
75 | Nea Ionia | Greece | 14233 | ||
76 | Budapest | Hungary | 1032 | ||
77 | Kistarcsa | Hungary | H-2143 | ||
78 | Szekesfehervar | Hungary | 8000 | ||
79 | Afula | Israel | 1834111 | ||
80 | Ashkelon | Israel | 7830604 | ||
81 | Hadera | Israel | 3810101 | ||
82 | Jerusalem | Israel | 9103102 | ||
83 | Petah Tikva | Israel | 4941492 | ||
84 | Rehovot | Israel | 7610001 | ||
85 | Tel Aviv | Israel | 6423906 | ||
86 | Tiberias | Israel | 1528001 | ||
87 | Zrifin | Israel | 7030000 | ||
88 | Bergamo | Lombardia | Italy | 24127 | |
89 | Brescia | Lombardia | Italy | 25123 | |
90 | Como | Lombardia | Italy | 22020 | |
91 | Milano | Lombardia | Italy | 20017 | |
92 | Milano | Lombardia | Italy | 20138 | |
93 | Milano | Lombardia | Italy | 20149 | |
94 | Pavia | Lombardia | Italy | 27100 | |
95 | Ancona | Marche | Italy | 60126 | |
96 | Arezzo | Toscana | Italy | 52040 | |
97 | Verona | Veneto | Italy | 37045 | |
98 | Iizuka | Fukuoka | Japan | 820-8505 | |
99 | Himeji | Hyogo | Japan | 670-0981 | |
100 | Kanazawa | Ishikawa | Japan | 920-8650 | |
101 | Sagamihara | Kanagawa | Japan | 252-5188 | |
102 | Yokohama | Kanagawa | Japan | 236-0051 | |
103 | Yokosuka | Kanagawa | Japan | 238-8567 | |
104 | Sendai | Miyagi | Japan | 981-3133 | |
105 | Naha | Okinawa | Japan | 902-8511 | |
106 | Takatsuki | Osaka | Japan | 569-1096 | |
107 | Yao | Osaka | Japan | 581-0011 | |
108 | Ureshino | Saga | Japan | 843-0393 | |
109 | Komatsushima | Tokushima | Japan | 773-8502 | |
110 | Meguro-ku | Tokyo | Japan | 152-8902 | |
111 | Minato-ku | Tokyo | Japan | 106-0031 | |
112 | Fukui | Japan | 910-8526 | ||
113 | Hiroshima | Japan | 734-8530 | ||
114 | Kumamoto | Japan | 862-8505 | ||
115 | Nagasaki | Japan | 850-8555 | ||
116 | Tokushima | Japan | 770-8539 | ||
117 | Toyama | Japan | 930-8550 | ||
118 | Seoul | Korea, Republic of | 138-736 | ||
119 | Amsterdam | Netherlands | 1105 AZ | ||
120 | Deventer | Netherlands | 7416 SE | ||
121 | Heerenveen | Netherlands | 8441 PW | ||
122 | Leeuwarden | Netherlands | 8901 BR | ||
123 | Veldhoven | Netherlands | 5504 DB | ||
124 | Bialystok | Poland | 15-276 | ||
125 | Krakow | Poland | 31-202 | ||
126 | Legnica | Poland | 59-220 | ||
127 | Lodz | Poland | 92-213 | ||
128 | Olsztyn | Poland | 10-010 | ||
129 | Poznan | Poland | 61-848 | ||
130 | Warszawa | Poland | 02-507 | ||
131 | Singapore | Singapore | 119228 | ||
132 | Singapore | Singapore | 169609 | ||
133 | Singapore | Singapore | 308433 | ||
134 | Singapore | Singapore | 768828 | ||
135 | L'Hospitalet de Llobregat | Barcelona | Spain | 08907 | |
136 | Santander | Cantabria | Spain | 39008 | |
137 | Majadahonda | Madrid | Spain | 28222 | |
138 | Barcelona | Spain | 08003 | ||
139 | Barcelona | Spain | 08023 | ||
140 | Valencia | Spain | 46010 | ||
141 | Valencia | Spain | 46026 | ||
142 | Helsingborg | Sweden | 251 87 | ||
143 | Karlstad | Sweden | 651 85 | ||
144 | Linköping | Sweden | 581 85 | ||
145 | Malmö | Sweden | 205 02 | ||
146 | Stockholm | Sweden | 118 83 | ||
147 | Örebro | Sweden | 701 85 | ||
148 | Liestal | Basel-Landschaft | Switzerland | 4410 | |
149 | Bruderholz | Switzerland | 4101 | ||
150 | Lugano | Switzerland | 6900 | ||
151 | Zürich | Switzerland | 8091 | ||
152 | Kaohsiung | Taiwan | 813 | ||
153 | New Taipei City | Taiwan | 220 | ||
154 | Taipei | Taiwan | 10016 | ||
155 | Taipei | Taiwan | 11217 | ||
156 | Chesterfield | Derbyshire | United Kingdom | S44 5DX | |
157 | Stevenage | Hertfordshire | United Kingdom | SG1 4AB |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 15371
- 2013-002287-11
Study Results
Participant Flow
Recruitment Details | The study was conducted at 144 centers in 24 countries between 29 November 2013 (first subject first visit) and 09 June 2015 (last subject last visit). |
---|---|
Pre-assignment Detail | Overall 632 subjects were enrolled, of them 176 were screen failure and 456 were randomized. One subject did not receive study drug after randomization. Among the 455 subjects who received study drug 348 completed the study (that is completed both the treatment and follow-up periods) and 108 subjects did not complete the study. |
Arm/Group Title | Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg |
---|---|---|---|---|---|
Arm/Group Description | Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days. |
Period Title: Treatment Period | |||||
STARTED | 92 | 91 | 91 | 91 | 91 |
COMPLETED | 73 | 70 | 76 | 69 | 74 |
NOT COMPLETED | 19 | 21 | 15 | 22 | 17 |
Period Title: Treatment Period | |||||
STARTED | 87 | 88 | 88 | 87 | 88 |
COMPLETED | 79 | 79 | 84 | 76 | 78 |
NOT COMPLETED | 8 | 9 | 4 | 11 | 10 |
Baseline Characteristics
Arm/Group Title | Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg | Total |
---|---|---|---|---|---|---|
Arm/Group Description | Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days. | Total of all reporting groups |
Overall Participants | 92 | 91 | 91 | 91 | 91 | 456 |
Age (years) [Mean (Standard Deviation) ] | ||||||
Mean (Standard Deviation) [years] |
67
(13.1)
|
67.6
(12.9)
|
67.6
(11.5)
|
66.7
(11.6)
|
68.9
(12.4)
|
67.6
(12.3)
|
Age, Customized (Count of Participants) | ||||||
<65 |
38
41.3%
|
38
41.8%
|
30
33%
|
38
41.8%
|
28
30.8%
|
172
37.7%
|
65-75 |
26
28.3%
|
19
20.9%
|
37
40.7%
|
32
35.2%
|
34
37.4%
|
148
32.5%
|
> 75 |
28
30.4%
|
34
37.4%
|
24
26.4%
|
21
23.1%
|
29
31.9%
|
136
29.8%
|
Sex: Female, Male (Count of Participants) | ||||||
Female |
19
20.7%
|
21
23.1%
|
19
20.9%
|
17
18.7%
|
14
15.4%
|
90
19.7%
|
Male |
73
79.3%
|
70
76.9%
|
72
79.1%
|
74
81.3%
|
77
84.6%
|
366
80.3%
|
Outcome Measures
Title | Change From Baseline in Log-Transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) to Week 12 |
---|---|
Description | Log-Transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) is a circulating plasma biomarker of cardiovascular function and prognosis in heart failure. |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Per Protocol Set (PPS) |
Arm/Group Title | Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg | Pooled 2.5 mg up to 10 mg |
---|---|---|---|---|---|---|
Arm/Group Description | Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days. | The three highest dose arms (BAY1021189 2.5 mg, 2.5-5 mg, and 2.5-10 mg) were pooled. |
Measure Participants | 69 | 69 | 73 | 67 | 73 | 213 |
Mean (Standard Deviation) [log-transformed picograms per milliliter] |
-0.28
(0.8197)
|
-0.265
(0.7658)
|
-0.32
(0.7799)
|
-0.353
(0.8404)
|
-0.529
(0.9475)
|
-0.402
(0.8603)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Pooled 2.5 mg up to 10 mg |
---|---|---|
Comments | For the primary analysis, the three highest active treatment groups (BAY1021189 2.5mg, BAY1021189 2.5 to 5mg, BAY1021189 2.5 to 10mg) were pooled and compared to the assigned placebo treatment group with a one-sided two-sample t-test at the significance level of 5 percent (%). Results are reported including 90% confidence intervals (CI) for the difference of means. The difference between the pooled treatment group and the placebo group is difference of means on the log scale. | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | = 0.1506 |
Comments | ||
Method | t-test, 1 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Log-Scale mean difference |
Estimated Value | -0.122 | |
Confidence Interval |
(2-Sided) 90% -0.32 to 0.07 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Placebo, BAY1021189 From 2.5 to 10 mg |
---|---|---|
Comments | In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only, since the primary analyses were not significant. | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | = 0.0483 |
Comments | ||
Method | t-test, 1 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Log-Scale mean difference |
Estimated Value | -0.2494 | |
Confidence Interval |
(2-Sided) 90% -0.5 to 0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Placebo, BAY1021189 From 2.5 to 5 mg |
---|---|---|
Comments | In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only, since the primary analyses were not significant. | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | = 0.3042 |
Comments | ||
Method | t-test, 1 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Log-Scale mean difference |
Estimated Value | -0.0731 | |
Confidence Interval |
(2-Sided) 90% -0.31 to 0.16 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Placebo, BAY1021189 2.5 mg |
---|---|---|
Comments | In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only, since the primary analyses were not significant. | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | = 0.3841 |
Comments | ||
Method | t-test, 1 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Log-Scale mean difference |
Estimated Value | -0.0396 | |
Confidence Interval |
(2-Sided) 90% -0.26 to 0.18 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Placebo, BAY1021189 1.25 Milligram (mg) |
---|---|---|
Comments | In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only. | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | = 0.5444 |
Comments | ||
Method | t-test, 1 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Log-Scale mean difference |
Estimated Value | 0.0151 | |
Confidence Interval |
(2-Sided) 90% -0.21 to 0.24 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Changes in Heart Function as Measured by Echocardiography, Left Ventricular End-Diastolic Volume (LVEDV), and Left Ventricular End-Systolic Volume (LVESV) From Baseline to Week 12 |
---|---|
Description | Left Ventricular End-Diastolic Volume (LVEDV) and Left ventricular end-systolic volume (LVESV) are measured echocardiography parameter. These are acquired during a non-invasive echocardiography examination. |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Evaluable subjects in full analysis set (FAS). |
Arm/Group Title | Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg |
---|---|---|---|---|---|
Arm/Group Description | Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days. |
Measure Participants | 92 | 91 | 91 | 91 | 91 |
Change in LVEDV |
-7.259
(40.676)
|
-5.525
(34.75)
|
-9.632
(35.081)
|
-17.093
(53.307)
|
-7.324
(31.896)
|
Change in LVESV |
-6.83
(32.407)
|
-8.585
(27.385)
|
-10.935
(27.146)
|
-15.485
(43.191)
|
-11.017
(26.525)
|
Title | Changes in Heart Function as Measured by Echocardiography, Left Ventricular Ejection Fraction (LVEF), From Baseline to Week 12 |
---|---|
Description | 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 noninvasive echocardiography examination. Formula: LVEF = 100*(LVEDV - LVESV)/LVEDV. |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Evaluable subjects in full analysis set (FAS). |
Arm/Group Title | Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg |
---|---|---|---|---|---|
Arm/Group Description | Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days. |
Measure Participants | 92 | 91 | 91 | 91 | 91 |
Mean (Standard Deviation) [percentage] |
1.515
(4.736)
|
2.84
(3.635)
|
2.741
(4.371)
|
2.07
(4.808)
|
3.682
(6.19)
|
Title | Change From Baseline in Systolic and Diastolic Blood Pressure to Week 12 |
---|---|
Description | Blood pressure was measured by monitor measurements after 10 minutes resting in a supine position (3 measurements taken approximately 2 minutes apart).The changes in blood pressure were recorded and the mean of the three measurements was analyzed. |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Evaluable subjects in safety analysis set (SAF). |
Arm/Group Title | Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg |
---|---|---|---|---|---|
Arm/Group Description | Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days. |
Measure Participants | 92 | 91 | 90 | 91 | 91 |
Change in SBP |
-5.142
(12.829)
|
-4.033
(13.3)
|
-3.733
(16.509)
|
-3.043
(15.934)
|
-5.64
(15.509)
|
Change in DBP |
-4.173
(8.6)
|
-0.486
(9.298)
|
-2.938
(11.101)
|
-1.338
(9.528)
|
-4.045
(10.604)
|
Title | Change From Baseline in Heart Rate to Week 12 |
---|---|
Description | Heart rate was measured after 10 minutes resting in a supine position (3 measurements taken approximately 2 minutes apart). The changes in heart rate were recorded and the mean of the three measurements was analyzed. |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Evaluable subjects in safety analysis set (SAF). |
Arm/Group Title | Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg |
---|---|---|---|---|---|
Arm/Group Description | Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days. |
Measure Participants | 92 | 91 | 90 | 91 | 91 |
Mean (Standard Deviation) [Beats per minute] |
-0.562
(12.897)
|
-0.352
(10.153)
|
-1.556
(10.2)
|
-0.99
(11.295)
|
0.545
(10.636)
|
Title | Number of Subjects With Clinical Events (Heart Failure [HF] Hospitalization and Cardio-Vascular [CV] Mortality) |
---|---|
Description | Clinical events (heart failure and mortality) were analyzed as CV death, and HF hospitalization at specified time points. |
Time Frame | Baseline until 16 weeks |
Outcome Measure Data
Analysis Population Description |
---|
FAS |
Arm/Group Title | Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg |
---|---|---|---|---|---|
Arm/Group Description | Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days. |
Measure Participants | 92 | 91 | 91 | 91 | 91 |
HF hospitalizations |
21
22.8%
|
18
19.8%
|
20
22%
|
10
11%
|
9
9.9%
|
CV death |
6
6.5%
|
5
5.5%
|
4
4.4%
|
2
2.2%
|
4
4.4%
|
Title | Number of Subjects With Implantable Cardioverter Defibrillators Cardiac Resynchronization Therapy With Defibrillation (ICD/CRT-D) Therapy |
---|---|
Description | ICD / CRT with defibrillation therapy (CRT-D) included previous appropriate interventions such as shocks or anti-tachycardic pacing (ATP) when diagnostic of sustained ventricular tachycardias in pre defined rapid zone. |
Time Frame | Baseline upto 16 weeks |
Outcome Measure Data
Analysis Population Description |
---|
No analysis was performed for this end point. |
Arm/Group Title | Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg |
---|---|---|---|---|---|
Arm/Group Description | Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days. |
Measure Participants | 0 | 0 | 0 | 0 | 0 |
Title | Number of Subjects With Treatment-Emergent Adverse Events |
---|---|
Description | An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; and another medically important serious event as judged by the investigator. AEs are considered to be treatment-emergent if they have started or worsened after first application of study drug up to 5 days after end of treatment with study drug. |
Time Frame | From the start of study treatment upto 5 days after the last dose of study drug |
Outcome Measure Data
Analysis Population Description |
---|
SAF |
Arm/Group Title | Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg |
---|---|---|---|---|---|
Arm/Group Description | Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days. |
Measure Participants | 92 | 91 | 90 | 91 | 91 |
Count of Participants [Participants] |
66
71.7%
|
60
65.9%
|
62
68.1%
|
62
68.1%
|
56
61.5%
|
Title | Change in Biomarkers From Baseline to Week 12: Osteopontin (ng/mL) |
---|---|
Description | |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Evaluable subjects in FAS |
Arm/Group Title | Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg |
---|---|---|---|---|---|
Arm/Group Description | Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days. |
Measure Participants | 73 | 69 | 73 | 65 | 71 |
Mean (Standard Deviation) [nanogram(s)/milliliter (ng/mL)] |
2.79
(42.049)
|
3.812
(39.248)
|
3.266
(52.957)
|
8.485
(41.97)
|
3.709
(36.048)
|
Title | Change in Biomarkers From Baseline to Week 12: TIMP-4 (pg/mL) |
---|---|
Description | TIMP-4: tissue inhibitor of matrix metalloproteinases 4 |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Evaluable subjects in FAS |
Arm/Group Title | Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg |
---|---|---|---|---|---|
Arm/Group Description | Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days. |
Measure Participants | 73 | 69 | 72 | 67 | 72 |
Mean (Standard Deviation) [picogram(s)/millilitre (pg/mL)] |
451.889
(1392.03)
|
1128.635
(1949.351)
|
643.626
(1441.954)
|
876.584
(1559.768)
|
397.603
(1420.223)
|
Title | Change in Biomarkers From Baseline to Week 12: cGMP (Pmol/mL) |
---|---|
Description | cGMP: cyclic guanosine monophosphate |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Evaluable subjects in FAS |
Arm/Group Title | Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg |
---|---|---|---|---|---|
Arm/Group Description | Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days. |
Measure Participants | 73 | 69 | 73 | 66 | 71 |
Mean (Standard Deviation) [picomole(s)/milliliter (pmol/mL)] |
78.874
(143.321)
|
79.767
(123.031)
|
92.352
(121.477)
|
80.888
(114.09)
|
63.563
(127.448)
|
Title | Change in Biomarkers From Baseline to Week 12: PIIINP (mcg/L) |
---|---|
Description | PIIINP: pro-collagen III N-terminal peptide |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Evaluable subjects in FAS |
Arm/Group Title | Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg |
---|---|---|---|---|---|
Arm/Group Description | Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days. |
Measure Participants | 70 | 69 | 72 | 67 | 73 |
Mean (Standard Deviation) [microgram(s)/liter (mcg/L)] |
-0.701
(7.246)
|
0.092
(3.958)
|
0.106
(5.145)
|
-0.71
(3.774)
|
-0.321
(4.452)
|
Title | Change in Biomarkers From Baseline to Week 12: GDF-15 (pg/mL) |
---|---|
Description | GDF-15: growth differentiation factor 15 |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Evaluable subjects in FAS |
Arm/Group Title | Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg |
---|---|---|---|---|---|
Arm/Group Description | Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days. |
Measure Participants | 73 | 69 | 73 | 66 | 71 |
Mean (Standard Deviation) [pg/mL] |
429.432
(3212.229)
|
496.456
(3132.738)
|
285.472
(2837.237)
|
468.369
(1786.062)
|
244.63
(2906.763)
|
Title | Change in Biomarkers From Baseline to Week 12: ST2 (pg/mL) |
---|---|
Description | ST2: suppression of tumorigenicity 2 |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Evaluable subjects in FAS |
Arm/Group Title | Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg |
---|---|---|---|---|---|
Arm/Group Description | Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days. |
Measure Participants | 73 | 69 | 72 | 67 | 72 |
Mean (Standard Deviation) [pg/mL] |
9457.677
(54702.45)
|
1623.869
(25086.72)
|
-1217.77
(35166.41)
|
6933.941
(20747.71)
|
3681.668
(32293.77)
|
Title | Change in Biomarkers From Baseline to Week 12: Gal-3 (μg/mL) |
---|---|
Description | Gal-3: Galectin-3 |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Evaluable subjects in FAS |
Arm/Group Title | Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg |
---|---|---|---|---|---|
Arm/Group Description | Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days. |
Measure Participants | 72 | 68 | 73 | 64 | 71 |
Mean (Standard Deviation) [mcg/L] |
0.802
(13.818)
|
0.233
(6.208)
|
-0.287
(3.729)
|
0.064
(5.64)
|
-0.38
(4.551)
|
Adverse Events
Time Frame | Treatment-emergent AEs were collected after first application of study medication up to 5 calendar days after end of treatment with study medication. | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||||
Arm/Group Title | Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg | |||||
Arm/Group Description | Subjects received placebo matched to vericiguat (Verquvo, BAY1021189) orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 1.25 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) 2.5 mg orally once daily for 12 weeks. Sham titrations included on Days 14 and 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 or 28 days. Sham titration included on Day 28. | Subjects received vericiguat (Verquvo, BAY1021189) for 12 weeks, starting on 2.5 mg once daily with potential up-titration to 5 mg once daily after 14 days, and up-titration to 10 mg once daily after 28 days. | |||||
All Cause Mortality |
||||||||||
Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 6/92 (6.5%) | 6/91 (6.6%) | 5/90 (5.6%) | 3/91 (3.3%) | 4/91 (4.4%) | |||||
Serious Adverse Events |
||||||||||
Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 30/92 (32.6%) | 26/91 (28.6%) | 26/90 (28.9%) | 20/91 (22%) | 25/91 (27.5%) | |||||
Blood and lymphatic system disorders | ||||||||||
Anaemia | 1/92 (1.1%) | 1 | 1/91 (1.1%) | 1 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 1/91 (1.1%) | 1 |
Thrombocytopenia | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Cardiac disorders | ||||||||||
Angina pectoris | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Atrial fibrillation | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 2/91 (2.2%) | 2 |
Cardiac arrest | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Cardiac failure | 8/92 (8.7%) | 14 | 13/91 (14.3%) | 14 | 10/90 (11.1%) | 11 | 3/91 (3.3%) | 4 | 3/91 (3.3%) | 4 |
Cardiac failure acute | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 1/91 (1.1%) | 1 | 0/91 (0%) | 0 |
Cardiac failure chronic | 5/92 (5.4%) | 5 | 2/91 (2.2%) | 3 | 5/90 (5.6%) | 5 | 3/91 (3.3%) | 6 | 4/91 (4.4%) | 4 |
Cardiac failure congestive | 1/92 (1.1%) | 1 | 2/91 (2.2%) | 3 | 3/90 (3.3%) | 3 | 2/91 (2.2%) | 2 | 3/91 (3.3%) | 4 |
Ventricular fibrillation | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 1/91 (1.1%) | 1 | 0/91 (0%) | 0 |
Ventricular tachycardia | 1/92 (1.1%) | 1 | 1/91 (1.1%) | 1 | 0/90 (0%) | 0 | 1/91 (1.1%) | 1 | 0/91 (0%) | 0 |
Ischaemic cardiomyopathy | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Left ventricular dysfunction | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/90 (1.1%) | 1 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Acute left ventricular failure | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 1/91 (1.1%) | 1 | 0/91 (0%) | 0 |
Gastrointestinal disorders | ||||||||||
Abdominal pain | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 1/91 (1.1%) | 1 |
Abdominal pain upper | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/90 (1.1%) | 1 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Diarrhoea | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Gastrointestinal haemorrhage | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 1/91 (1.1%) | 1 | 0/91 (0%) | 0 |
Melaena | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 1/91 (1.1%) | 1 |
Small intestinal obstruction | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 1/91 (1.1%) | 1 | 0/91 (0%) | 0 |
Upper gastrointestinal haemorrhage | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/90 (1.1%) | 1 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Mechanical ileus | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Incarcerated umbilical hernia | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
General disorders | ||||||||||
Chest pain | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/90 (0%) | 0 | 1/91 (1.1%) | 1 | 1/91 (1.1%) | 1 |
Death | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/90 (1.1%) | 1 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Multi-organ failure | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 1/91 (1.1%) | 1 | 0/91 (0%) | 0 |
Oedema peripheral | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 1/91 (1.1%) | 1 |
Sudden death | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 1/91 (1.1%) | 1 | 1/91 (1.1%) | 1 |
General physical health deterioration | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 1/91 (1.1%) | 1 |
Device dislocation | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 1/91 (1.1%) | 1 | 0/91 (0%) | 0 |
Hepatobiliary disorders | ||||||||||
Cholangitis | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 1/91 (1.1%) | 1 |
Cholecystitis | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 1/91 (1.1%) | 1 |
Infections and infestations | ||||||||||
Bronchitis | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 1/91 (1.1%) | 1 | 2/91 (2.2%) | 2 |
Escherichia sepsis | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Pneumonia | 1/92 (1.1%) | 1 | 1/91 (1.1%) | 1 | 0/90 (0%) | 0 | 2/91 (2.2%) | 2 | 1/91 (1.1%) | 1 |
Gastroenteritis | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/90 (1.1%) | 1 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Urinary tract infection | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Pneumococcal sepsis | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/90 (1.1%) | 1 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||||||
Fall | 2/92 (2.2%) | 2 | 2/91 (2.2%) | 2 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Hip fracture | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 1/91 (1.1%) | 1 |
Contusion | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Incision site haemorrhage | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 1/91 (1.1%) | 2 |
Investigations | ||||||||||
Transplant evaluation | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Metabolism and nutrition disorders | ||||||||||
Fluid overload | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Gout | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Hyperglycaemia | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Hyperkalaemia | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Hypoglycaemia | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/90 (1.1%) | 1 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Hypokalaemia | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 2/90 (2.2%) | 2 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Metabolic acidosis | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Type 2 diabetes mellitus | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 1/91 (1.1%) | 1 | 0/91 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||||||
Arthralgia | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/90 (1.1%) | 1 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
Gastric cancer | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 1/91 (1.1%) | 1 |
Intra-abdominal haemangioma | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/90 (1.1%) | 1 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Non-small cell lung cancer | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 1/91 (1.1%) | 1 | 0/91 (0%) | 0 |
Nervous system disorders | ||||||||||
Cerebrovascular accident | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/90 (1.1%) | 1 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Cervicobrachial syndrome | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 1/91 (1.1%) | 1 |
Subarachnoid haemorrhage | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/90 (1.1%) | 1 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Headache | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 1/91 (1.1%) | 1 |
Syncope | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 1/91 (1.1%) | 1 |
Renal and urinary disorders | ||||||||||
Renal failure | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/90 (1.1%) | 1 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Urinary retention | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 1/90 (1.1%) | 1 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Acute kidney injury | 3/92 (3.3%) | 3 | 4/91 (4.4%) | 4 | 2/90 (2.2%) | 2 | 1/91 (1.1%) | 1 | 3/91 (3.3%) | 3 |
Respiratory, thoracic and mediastinal disorders | ||||||||||
Acute pulmonary oedema | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/90 (0%) | 0 | 1/91 (1.1%) | 1 | 0/91 (0%) | 0 |
Acute respiratory failure | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 1/91 (1.1%) | 1 |
Chronic obstructive pulmonary disease | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 1/90 (1.1%) | 1 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Dyspnoea | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/90 (0%) | 0 | 1/91 (1.1%) | 1 | 1/91 (1.1%) | 1 |
Pneumonia aspiration | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Pulmonary congestion | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 1/91 (1.1%) | 1 |
Pulmonary oedema | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 1/91 (1.1%) | 1 | 0/91 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||||||||
Rash | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 1/91 (1.1%) | 1 |
Rash pruritic | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 1/91 (1.1%) | 1 |
Surgical and medical procedures | ||||||||||
Catheter placement | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Vascular disorders | ||||||||||
Hypertension | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Hypotension | 0/92 (0%) | 0 | 0/91 (0%) | 0 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 1/91 (1.1%) | 1 |
Deep vein thrombosis | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/90 (0%) | 0 | 0/91 (0%) | 0 | 0/91 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||
Placebo | BAY1021189 1.25 Milligram (mg) | BAY1021189 2.5 mg | BAY1021189 From 2.5 to 5 mg | BAY1021189 From 2.5 to 10 mg | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 24/92 (26.1%) | 25/91 (27.5%) | 20/90 (22.2%) | 23/91 (25.3%) | 28/91 (30.8%) | |||||
Cardiac disorders | ||||||||||
Cardiac failure chronic | 4/92 (4.3%) | 5 | 1/91 (1.1%) | 1 | 5/90 (5.6%) | 5 | 2/91 (2.2%) | 2 | 0/91 (0%) | 0 |
Gastrointestinal disorders | ||||||||||
Abdominal pain upper | 2/92 (2.2%) | 2 | 5/91 (5.5%) | 6 | 1/90 (1.1%) | 1 | 1/91 (1.1%) | 1 | 0/91 (0%) | 0 |
Dyspepsia | 0/92 (0%) | 0 | 1/91 (1.1%) | 1 | 0/90 (0%) | 0 | 1/91 (1.1%) | 1 | 5/91 (5.5%) | 7 |
Nausea | 3/92 (3.3%) | 4 | 5/91 (5.5%) | 6 | 3/90 (3.3%) | 3 | 1/91 (1.1%) | 1 | 1/91 (1.1%) | 1 |
General disorders | ||||||||||
Asthenia | 3/92 (3.3%) | 3 | 0/91 (0%) | 0 | 2/90 (2.2%) | 2 | 5/91 (5.5%) | 5 | 2/91 (2.2%) | 2 |
Metabolism and nutrition disorders | ||||||||||
Hyperuricaemia | 1/92 (1.1%) | 1 | 0/91 (0%) | 0 | 2/90 (2.2%) | 2 | 5/91 (5.5%) | 5 | 0/91 (0%) | 0 |
Hypokalaemia | 3/92 (3.3%) | 3 | 5/91 (5.5%) | 5 | 2/90 (2.2%) | 2 | 2/91 (2.2%) | 2 | 5/91 (5.5%) | 6 |
Nervous system disorders | ||||||||||
Dizziness | 5/92 (5.4%) | 6 | 3/91 (3.3%) | 3 | 2/90 (2.2%) | 2 | 2/91 (2.2%) | 2 | 5/91 (5.5%) | 5 |
Respiratory, thoracic and mediastinal disorders | ||||||||||
Dyspnoea | 5/92 (5.4%) | 5 | 1/91 (1.1%) | 1 | 3/90 (3.3%) | 3 | 2/91 (2.2%) | 3 | 4/91 (4.4%) | 4 |
Cough | 6/92 (6.5%) | 7 | 8/91 (8.8%) | 8 | 4/90 (4.4%) | 4 | 4/91 (4.4%) | 4 | 4/91 (4.4%) | 4 |
Vascular disorders | ||||||||||
Hypotension | 6/92 (6.5%) | 6 | 5/91 (5.5%) | 5 | 5/90 (5.6%) | 6 | 4/91 (4.4%) | 4 | 14/91 (15.4%) | 17 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title | Therapeutic Area Head |
---|---|
Organization | Bayer AG |
Phone | (+) 1-888-8422937 |
clinical-trials-contact@bayer.com |
- 15371
- 2013-002287-11