Trial Outcomes & Findings for Study of Ralinepag on Exercise Capacity by Cardiopulmonary Exercise Testing (CPET) in WHO Group 1 PH Subjects (NCT NCT04084678)
NCT ID: NCT04084678
Last Updated: 2026-07-06
Results Overview
Peak VO2 by CPET was measured at Baseline (prior to starting study drug) and Week 28
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
10 participants
Primary outcome timeframe
Baseline to Week 28
Results posted on
2026-07-06
Participant Flow
Participant milestones
| Measure |
Ralinepag
Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the individual maximum tolerated dose (maximum dose of 1400 mcg)
Ralinepag: Oral ralinepag
|
Placebo
Matching placebo tablets (oral)
Placebo: Matching oral tablets
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
Ralinepag
Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the individual maximum tolerated dose (maximum dose of 1400 mcg)
Ralinepag: Oral ralinepag
|
Placebo
Matching placebo tablets (oral)
Placebo: Matching oral tablets
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
4
|
0
|
Baseline Characteristics
Study of Ralinepag on Exercise Capacity by Cardiopulmonary Exercise Testing (CPET) in WHO Group 1 PH Subjects
Baseline characteristics by cohort
| Measure |
Placebo
n=2 Participants
Matching placebo tablets (oral)
Placebo: Matching oral tablets
|
Total
n=10 Participants
Total of all reporting groups
|
Ralinepag
n=8 Participants
Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the individual maximum tolerated dose (maximum dose of 1400 mcg)
Ralinepag: Oral ralinepag
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
5 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
6 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=27 Participants
|
1 participants
n=267 Participants
|
1 participants
n=9 Participants
|
|
Region of Enrollment
Brazil
|
1 participants
n=27 Participants
|
3 participants
n=267 Participants
|
2 participants
n=9 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=27 Participants
|
2 participants
n=267 Participants
|
2 participants
n=9 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=27 Participants
|
2 participants
n=267 Participants
|
2 participants
n=9 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=27 Participants
|
1 participants
n=267 Participants
|
1 participants
n=9 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=27 Participants
|
1 participants
n=267 Participants
|
0 participants
n=9 Participants
|
|
Baseline Weight
|
68.75 kg
n=27 Participants
|
72.80 kg
n=267 Participants
|
72.80 kg
n=9 Participants
|
|
Baseline Height
|
157.0 cm
n=27 Participants
|
161.5 cm
n=267 Participants
|
165.5 cm
n=9 Participants
|
|
Baseline Body Mass Index
|
27.40 kg/m^2
n=27 Participants
|
26.95 kg/m^2
n=267 Participants
|
26.95 kg/m^2
n=9 Participants
|
|
Age, Continuous
|
45.0 years
n=27 Participants
|
53.0 years
n=267 Participants
|
59.0 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
7 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 28Population: The study was discontinued by the Sponsor on 27 February 2023 due to slow enrollment.
Peak VO2 by CPET was measured at Baseline (prior to starting study drug) and Week 28
Outcome measures
| Measure |
Ralinepag
n=2 Participants
Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the individual maximum tolerated dose (maximum dose of 1400 mcg)
Ralinepag: Oral ralinepag
|
Placebo
n=2 Participants
Matching placebo tablets (oral)
|
|---|---|---|
|
Change From Baseline in Peak VO2 Assessed by CPET
|
-1.953 mL/kg/min
Interval -3.46 to -0.45
|
0.929 mL/kg/min
Interval -0.73 to 2.59
|
Adverse Events
Ralinepag
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ralinepag
n=8 participants at risk
Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the individual maximum tolerated dose (maximum dose of 1400 mcg)
Ralinepag: Oral ralinepag
|
Placebo
n=2 participants at risk
Matching placebo tablets (oral)
Placebo: Matching oral tablets
|
|---|---|---|
|
Infections and infestations
Submandibular space abscess
|
12.5%
1/8 • Number of events 2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
Other adverse events
| Measure |
Ralinepag
n=8 participants at risk
Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the individual maximum tolerated dose (maximum dose of 1400 mcg)
Ralinepag: Oral ralinepag
|
Placebo
n=2 participants at risk
Matching placebo tablets (oral)
Placebo: Matching oral tablets
|
|---|---|---|
|
Nervous system disorders
Headache
|
87.5%
7/8 • Number of events 14 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
100.0%
2/2 • Number of events 3 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
75.0%
6/8 • Number of events 9 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
4/8 • Number of events 7 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
37.5%
3/8 • Number of events 11 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
37.5%
3/8 • Number of events 7 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
2/8 • Number of events 4 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
2/8 • Number of events 2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • Number of events 2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Investigations
Electrocardiogram QT prolonged
|
12.5%
1/8 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Vascular disorders
Flushing
|
12.5%
1/8 • Number of events 3 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
50.0%
1/2 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Investigations
Heart rate decreased
|
12.5%
1/8 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Investigations
N-terminal prohormone brain natriuretic peptide decreased
|
12.5%
1/8 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
General disorders
Oedema peripheral
|
12.5%
1/8 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
General disorders
Peripheral swelling
|
12.5%
1/8 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Nervous system disorders
Somnolence
|
12.5%
1/8 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Gastrointestinal disorders
Vomitting
|
12.5%
1/8 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
0.00%
0/2 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/8 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
50.0%
1/2 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/8 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
50.0%
1/2 • Number of events 1 • The Treatment Phase of the study lasted up to 28 weeks. From Screening until the completion of study termination assessments, subjects participated in the study for approximately 226 days. This study was terminated early by the Sponsor due to to slow enrollment; all safety data were collected for each subject from screening until the subject's last scheduled visit.
|
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