Trial Outcomes & Findings for Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction (NCT NCT03037580)
NCT ID: NCT03037580
Last Updated: 2020-11-10
Results Overview
The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
84 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2020-11-10
Participant Flow
Participant milestones
| Measure |
Oral Treprostinil
Sustained-release oral tablets for TID administration
Oral treprostinil: Sustained-release oral tablets for TID administration
|
Placebo
Placebo (sugar pill) for TID oral administration
Placebo: Placebo (sugar pill) for TID oral administration
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
43
|
|
Overall Study
COMPLETED
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
16
|
16
|
Reasons for withdrawal
| Measure |
Oral Treprostinil
Sustained-release oral tablets for TID administration
Oral treprostinil: Sustained-release oral tablets for TID administration
|
Placebo
Placebo (sugar pill) for TID oral administration
Placebo: Placebo (sugar pill) for TID oral administration
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
12
|
15
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction
Baseline characteristics by cohort
| Measure |
Oral Treprostinil
n=41 Participants
Sustained-release oral tablets for TID administration
Oral treprostinil: Sustained-release oral tablets for TID administration
|
Placebo
n=43 Participants
Placebo (sugar pill) for TID oral administration
Placebo: Placebo (sugar pill) for TID oral administration
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.0 years
n=5 Participants
|
74.0 years
n=7 Participants
|
74.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Etiology of HFpEF
Hypertension
|
21 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Etiology of HFpEF
Coronary artery disease
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Etiology of HFpEF
Obesity
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Etiology of HFpEF
Diabetes
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Etiology of HFpEF
Other
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Safety Population
The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.
Outcome measures
| Measure |
Oral Treprostinil
n=29 Participants
Sustained-release oral tablets for TID administration
Oral treprostinil: Sustained-release oral tablets for TID administration
|
Placebo
n=28 Participants
Placebo (sugar pill) for TID oral administration
Placebo: Placebo (sugar pill) for TID oral administration
|
|---|---|---|
|
Change in 6MWD From Baseline to Week 24
|
21.0 meters
Interval -195.0 to 62.0
|
23.3 meters
Interval -140.0 to 104.0
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Safety Population
The NT-proBNP concentration is a biomarker associated with changes in right heart morphology and function.
Outcome measures
| Measure |
Oral Treprostinil
n=28 Participants
Sustained-release oral tablets for TID administration
Oral treprostinil: Sustained-release oral tablets for TID administration
|
Placebo
n=30 Participants
Placebo (sugar pill) for TID oral administration
Placebo: Placebo (sugar pill) for TID oral administration
|
|---|---|---|
|
Change in NT-proBNP Levels From Baseline to Week 24
|
9.5 pmol/L
Interval -133.0 to 499.0
|
11.5 pmol/L
Interval -231.0 to 172.0
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Safety Population
Clinical worsening was defined as the occurrence of any 1 of the following clinical worsening events: hospitalization due to a cardiopulmonary indication (a non-elective hospitalization lasting at least 24 hours in duration caused by clinical conditions directly related to PH and/or heart failure), outpatient administration of IV diuretics, death (all causes), decrease in 6MWD \>15% from Baseline (or the subject was too ill to walk, and the cause was directly related to the disease under study) at 2 consecutive visits on different days (except Week 24).
Outcome measures
| Measure |
Oral Treprostinil
n=41 Participants
Sustained-release oral tablets for TID administration
Oral treprostinil: Sustained-release oral tablets for TID administration
|
Placebo
n=43 Participants
Placebo (sugar pill) for TID oral administration
Placebo: Placebo (sugar pill) for TID oral administration
|
|---|---|---|
|
Number of Subjects With First Clinical Worsening Event From Baseline to Week 24
First Clinical Worsening Event
|
6 Participants
|
5 Participants
|
|
Number of Subjects With First Clinical Worsening Event From Baseline to Week 24
No clinical worsening event
|
35 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Safety Population
The WHO functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment).
Outcome measures
| Measure |
Oral Treprostinil
n=41 Participants
Sustained-release oral tablets for TID administration
Oral treprostinil: Sustained-release oral tablets for TID administration
|
Placebo
n=43 Participants
Placebo (sugar pill) for TID oral administration
Placebo: Placebo (sugar pill) for TID oral administration
|
|---|---|---|
|
Change in WHO FC From Baseline to Week 24
Baseline · WHO FC I
|
1 Participants
|
1 Participants
|
|
Change in WHO FC From Baseline to Week 24
Baseline · WHO FC II
|
19 Participants
|
17 Participants
|
|
Change in WHO FC From Baseline to Week 24
Baseline · WHO FC III
|
21 Participants
|
24 Participants
|
|
Change in WHO FC From Baseline to Week 24
Baseline · WHO FC IV
|
0 Participants
|
1 Participants
|
|
Change in WHO FC From Baseline to Week 24
Baseline · Not analyzed
|
0 Participants
|
0 Participants
|
|
Change in WHO FC From Baseline to Week 24
Week 24 · WHO FC I
|
4 Participants
|
1 Participants
|
|
Change in WHO FC From Baseline to Week 24
Week 24 · WHO FC II
|
10 Participants
|
16 Participants
|
|
Change in WHO FC From Baseline to Week 24
Week 24 · WHO FC III
|
15 Participants
|
11 Participants
|
|
Change in WHO FC From Baseline to Week 24
Week 24 · WHO FC IV
|
0 Participants
|
0 Participants
|
|
Change in WHO FC From Baseline to Week 24
Week 24 · Not analyzed
|
12 Participants
|
15 Participants
|
Adverse Events
Oral Treprostinil
Serious events: 11 serious events
Other events: 37 other events
Deaths: 0 deaths
Placebo
Serious events: 8 serious events
Other events: 38 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Oral Treprostinil
n=41 participants at risk
Sustained-release oral tablets for TID administration
Oral treprostinil: Sustained-release oral tablets for TID administration
|
Placebo
n=43 participants at risk
Placebo (sugar pill) for TID oral administration
Placebo: Placebo (sugar pill) for TID oral administration
|
|---|---|---|
|
Metabolism and nutrition disorders
Fluid overload
|
4.9%
2/41 • Number of events 2 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
2.3%
1/43 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.4%
1/41 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
0.00%
0/43 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/41 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
2.3%
1/43 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Infections and infestations
Bronchitis viral
|
2.4%
1/41 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
0.00%
0/43 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Cardiac disorders
Cardiac failure acute
|
2.4%
1/41 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
4.7%
2/43 • Number of events 3 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/41 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
2.3%
1/43 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
2.4%
1/41 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
0.00%
0/43 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Gastrointestinal disorders
Gastritis erosive
|
2.4%
1/41 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
0.00%
0/43 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.4%
1/41 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
0.00%
0/43 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.4%
1/41 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
0.00%
0/43 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
1/41 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
0.00%
0/43 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
General disorders
Non-cardiac chest pain
|
2.4%
1/41 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
0.00%
0/43 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Infections and infestations
Sepsis
|
2.4%
1/41 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
0.00%
0/43 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/41 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
2.3%
1/43 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/41 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
2.3%
1/43 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/41 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
2.3%
1/43 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/41 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
2.3%
1/43 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/41 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
2.3%
1/43 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/41 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
2.3%
1/43 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
Other adverse events
| Measure |
Oral Treprostinil
n=41 participants at risk
Sustained-release oral tablets for TID administration
Oral treprostinil: Sustained-release oral tablets for TID administration
|
Placebo
n=43 participants at risk
Placebo (sugar pill) for TID oral administration
Placebo: Placebo (sugar pill) for TID oral administration
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
46.3%
19/41 • Number of events 23 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
37.2%
16/43 • Number of events 19 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Nervous system disorders
Headache
|
53.7%
22/41 • Number of events 27 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
27.9%
12/43 • Number of events 14 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Gastrointestinal disorders
Nausea
|
31.7%
13/41 • Number of events 14 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
14.0%
6/43 • Number of events 7 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
General disorders
Fatigue
|
19.5%
8/41 • Number of events 10 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
23.3%
10/43 • Number of events 13 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.1%
7/41 • Number of events 7 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
20.9%
9/43 • Number of events 10 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Nervous system disorders
Dizziness
|
12.2%
5/41 • Number of events 7 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
20.9%
9/43 • Number of events 10 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
General disorders
Oedema peripheral
|
12.2%
5/41 • Number of events 5 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
14.0%
6/43 • Number of events 6 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.1%
7/41 • Number of events 10 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
7.0%
3/43 • Number of events 3 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
3/41 • Number of events 3 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
16.3%
7/43 • Number of events 7 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.2%
5/41 • Number of events 8 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
9.3%
4/43 • Number of events 5 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
General disorders
Chest pain
|
9.8%
4/41 • Number of events 4 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
7.0%
3/43 • Number of events 3 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Vascular disorders
Flushing
|
12.2%
5/41 • Number of events 5 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
4.7%
2/43 • Number of events 2 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.9%
2/41 • Number of events 3 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
11.6%
5/43 • Number of events 5 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Gastrointestinal disorders
Vomiting
|
12.2%
5/41 • Number of events 5 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
4.7%
2/43 • Number of events 2 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.8%
4/41 • Number of events 4 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
4.7%
2/43 • Number of events 2 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.4%
1/41 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
11.6%
5/43 • Number of events 5 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Gastrointestinal disorders
Flatulence
|
7.3%
3/41 • Number of events 3 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
7.0%
3/43 • Number of events 3 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Vascular disorders
Hypotension
|
12.2%
5/41 • Number of events 6 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
2.3%
1/43 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
4.9%
2/41 • Number of events 2 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
9.3%
4/43 • Number of events 4 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.8%
4/41 • Number of events 4 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
2.3%
1/43 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Infections and infestations
Bronchitis
|
9.8%
4/41 • Number of events 4 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
2.3%
1/43 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Gastrointestinal disorders
Constipation
|
4.9%
2/41 • Number of events 2 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
7.0%
3/43 • Number of events 3 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.9%
2/41 • Number of events 2 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
7.0%
3/43 • Number of events 3 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
1/41 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
9.3%
4/43 • Number of events 4 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.3%
3/41 • Number of events 3 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
4.7%
2/43 • Number of events 2 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
General disorders
Pain
|
9.8%
4/41 • Number of events 4 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
2.3%
1/43 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
4.9%
2/41 • Number of events 2 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
7.0%
3/43 • Number of events 3 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.9%
2/41 • Number of events 2 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
7.0%
3/43 • Number of events 3 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Musculoskeletal and connective tissue disorders
Decreased appetite
|
7.3%
3/41 • Number of events 3 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
2.3%
1/43 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.3%
3/41 • Number of events 3 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
2.3%
1/43 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.3%
3/41 • Number of events 3 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
2.3%
1/43 • Number of events 1 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Investigations
Weight increased
|
9.8%
4/41 • Number of events 4 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
0.00%
0/43 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Investigations
Blood creatinine increased
|
7.3%
3/41 • Number of events 3 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
0.00%
0/43 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/41 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
7.0%
3/43 • Number of events 4 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/41 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
7.0%
3/43 • Number of events 3 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.3%
3/41 • Number of events 4 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
0.00%
0/43 • The Treatment Phase was 24 weeks for each subject. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and/or Principal Investigator agree not to publish or publicly present any interim results of the study without the prior written consent of Sponsor, not to be unreasonably withheld or delayed. Institution and/or Principal Investigator further agree to provide Sponsor with drafts of any such publication or presentation for review and approval no less than 30 days prior to submission for publication or the date of public presentation.
- Publication restrictions are in place
Restriction type: OTHER