Trial Outcomes & Findings for Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF (NCT NCT03043651)
NCT ID: NCT03043651
Last Updated: 2020-10-22
Results Overview
The primary objective of this study was to evaluate the long-term safety of oral treprostinil in subjects with PH associated with HFpEF for subjects who completed Study TDE-HF-301. The number of subjects with adverse events during the study is reported as the primary outcome measure, which was the only outcome measurement reported for this Sponsor-terminated study.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
48 participants
Primary outcome timeframe
Baseline through study completion, up to approximately 25 months
Results posted on
2020-10-22
Participant Flow
Participant milestones
| Measure |
Oral Treprostinil
Sustained-release tablets for TID administration
Oral Treprostinil: Sustained-release oral tablets for TID administration
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
48
|
Reasons for withdrawal
| Measure |
Oral Treprostinil
Sustained-release tablets for TID administration
Oral Treprostinil: Sustained-release oral tablets for TID administration
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Progressive Disease
|
2
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Study Terminated by Sponsor
|
39
|
Baseline Characteristics
Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF
Baseline characteristics by cohort
| Measure |
Oral Treprostinil
n=48 Participants
Sustained-release tablets for TID administration
Oral Treprostinil: Sustained-release oral tablets for TID administration
|
|---|---|
|
Age, Continuous
|
76.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through study completion, up to approximately 25 monthsPopulation: Safety Population
The primary objective of this study was to evaluate the long-term safety of oral treprostinil in subjects with PH associated with HFpEF for subjects who completed Study TDE-HF-301. The number of subjects with adverse events during the study is reported as the primary outcome measure, which was the only outcome measurement reported for this Sponsor-terminated study.
Outcome measures
| Measure |
Oral Treprostinil
n=48 Participants
Sustained-release tablets for TID administration
Oral Treprostinil: Sustained-release oral tablets for TID administration
|
|---|---|
|
Long-term Safety of Oral Treprostinil in Subjects With PH Associated With HFpEF for Subjects Who Completed Study TDE-HF-301
|
47 Participants
|
Adverse Events
Oral Treprostinil
Serious events: 19 serious events
Other events: 47 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Oral Treprostinil
n=48 participants at risk
Sustained-release tablets for TID administration
Oral Treprostinil: Sustained-release oral tablets for TID administration
|
|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
General disorders
Chest pain
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Psychiatric disorders
Confusional state
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
General disorders
Death
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Investigations
Electrocardiogram QT prolonged
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Infections and infestations
Endocarditis
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Metabolism and nutrition disorders
Fluid overload
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Gastrointestinal disorders
Gastrointestinal angiectasia
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Nervous system disorders
Headache
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Gastrointestinal disorders
Melaena
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Nervous system disorders
Metabolic encephalopathy
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Infections and infestations
Sepsis
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Cardiac disorders
Sinus bradycardia
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Cardiac disorders
Sinus node dysfunction
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Nervous system disorders
Syncope
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Cardiac disorders
Tachyarrhythmia
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Renal and urinary disorders
Acute kidney injury
|
8.3%
4/48 • Number of events 5 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Cardiac disorders
Cardiac failure
|
6.2%
3/48 • Number of events 3 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
4.2%
2/48 • Number of events 2 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Cardiac disorders
Cardiac failure acute
|
4.2%
2/48 • Number of events 2 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Cardiac disorders
Cardiac failure congestive
|
4.2%
2/48 • Number of events 2 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.2%
2/48 • Number of events 2 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.2%
2/48 • Number of events 3 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Infections and infestations
Pneumonia
|
4.2%
2/48 • Number of events 3 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Renal and urinary disorders
Azotaemia
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Cardiac disorders
Cardiomyopathy
|
2.1%
1/48 • Number of events 1 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
Other adverse events
| Measure |
Oral Treprostinil
n=48 participants at risk
Sustained-release tablets for TID administration
Oral Treprostinil: Sustained-release oral tablets for TID administration
|
|---|---|
|
Nervous system disorders
Headache
|
64.6%
31/48 • Number of events 35 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Gastrointestinal disorders
Diarrhoea
|
54.2%
26/48 • Number of events 28 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Gastrointestinal disorders
Nausea
|
35.4%
17/48 • Number of events 20 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
General disorders
Fatigue
|
31.2%
15/48 • Number of events 17 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
27.1%
13/48 • Number of events 20 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Nervous system disorders
Dizziness
|
18.8%
9/48 • Number of events 10 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.8%
9/48 • Number of events 10 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
General disorders
Oedema peripheral
|
18.8%
9/48 • Number of events 9 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
8/48 • Number of events 8 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
8/48 • Number of events 8 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
14.6%
7/48 • Number of events 7 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
6/48 • Number of events 8 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
6/48 • Number of events 6 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Renal and urinary disorders
Acute kidney injury
|
10.4%
5/48 • Number of events 7 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Investigations
Blood creatinine increased
|
10.4%
5/48 • Number of events 5 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
General disorders
Chest pain
|
10.4%
5/48 • Number of events 6 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Vascular disorders
Flushing
|
10.4%
5/48 • Number of events 5 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.4%
5/48 • Number of events 5 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Infections and infestations
Pneumonia
|
10.4%
5/48 • Number of events 6 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.4%
5/48 • Number of events 5 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
4/48 • Number of events 4 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Cardiac disorders
Atrial fibrillation
|
8.3%
4/48 • Number of events 6 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
4/48 • Number of events 4 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
4/48 • Number of events 4 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Vascular disorders
Hypotension
|
8.3%
4/48 • Number of events 5 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
General disorders
Oedema
|
8.3%
4/48 • Number of events 4 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
4/48 • Number of events 4 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Infections and infestations
Sinusitis
|
8.3%
4/48 • Number of events 4 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
4/48 • Number of events 5 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
3/48 • Number of events 3 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
3/48 • Number of events 3 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.2%
3/48 • Number of events 3 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Cardiac disorders
Cardiac failure
|
6.2%
3/48 • Number of events 4 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
3/48 • Number of events 3 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.2%
3/48 • Number of events 3 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
3/48 • Number of events 3 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
3/48 • Number of events 4 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
6.2%
3/48 • Number of events 3 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Cardiac disorders
Palpitations
|
6.2%
3/48 • Number of events 3 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
3/48 • Number of events 4 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Nervous system disorders
Presyncope
|
6.2%
3/48 • Number of events 3 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
3/48 • Number of events 4 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Ear and labyrinth disorders
Vertigo
|
6.2%
3/48 • Number of events 3 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.2%
3/48 • Number of events 4 • The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
|
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 the 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