Trial record 1 of 1 for: 2018-003289-15

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Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure (SEQUOIA)

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ClinicalTrials.gov Identifier: NCT03750552

Recruitment Status : Completed

First Posted : November 23, 2018

Results First Posted : September 14, 2022

Last Update Posted : September 14, 2022

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Sponsor:

Information provided by (Responsible Party):

Theravance Biopharma

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Symptomatic Neurogenic Orthostatic Hypotension
Interventions	Drug: ampreloxetine Drug: Placebo
Enrollment	195

Participant Flow

Recruitment Details	195 participants were enrolled across 76 sites in Australia, Austria, Bulgaria, Canada, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Portugal, Spain, Russia, Ukraine, United Kingdom and the United States.
Pre-assignment Details	Overall, 194 randomized participants received at least one dose of study drug. Eight participants from one site were excluded from all analysis sets except the Randomized Analysis Set due to data integrity concerns.


Arm/Group Title	Ampreloxetine	Placebo
Arm/Group Description	Participants received ampreloxetine...	Participants received placebo QD fo...
Arm/Group Description	Participants received ampreloxetine at a dose of 10 mg once daily (QD) for 4 weeks. Ampreloxetine: Oral tablet, QD	Participants received placebo QD for 4 weeks. Placebo: Oral tablet, QD
Period Title: Overall Study
Started	98	97
Safety Analysis Set	96	90
Full Analysis Set	94	90
Completed	90	95
Not Completed	8	2
Reason Not Completed
Adverse Event	5	1
Withdrawal by Subject	1	1
Other	2	0

Baseline Characteristics

Arm/Group Title		Ampreloxetine	Placebo	Total
Arm/Group Description		Participants received ampreloxetine...	Participants received placebo once ...	Total of all reporting groups
Arm/Group Description		Participants received ampreloxetine at a dose of 10 mg once daily (QD) for 4 weeks. Ampreloxetine: Oral tablet, QD	Participants received placebo once daily (QD) for 4 weeks. Placebo: Oral tablet, QD	Total of all reporting groups
Overall Number of Baseline Participants		98	97	195
Baseline Analysis Population Description		...
Baseline Analysis Population Description		The Baseline Analysis Population includes all participants from the Randomized Analysis Set.
Age, Customized Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	98 participants	97 participants	195 participants
< 65 years		28 28.6%	25 25.8%	53 27.2%
≥ 65 years		70 71.4%	72 74.2%	142 72.8%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	98 participants	97 participants	195 participants
	Female	37 37.8%	29 29.9%	66 33.8%
	Male	61 62.2%	68 70.1%	129 66.2%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	98 participants	97 participants	195 participants
	Hispanic or Latino	1 1.0%	3 3.1%	4 2.1%
	Not Hispanic or Latino	92 93.9%	91 93.8%	183 93.8%
	Unknown or Not Reported	5 5.1%	3 3.1%	8 4.1%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	98 participants	97 participants	195 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	1 1.0%	2 2.1%	3 1.5%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	1 1.0%	0 0.0%	1 0.5%
	White	96 98.0%	94 96.9%	190 97.4%
	More than one race	0 0.0%	1 1.0%	1 0.5%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1.Primary Outcome


Title	Change From Baseline in Orthostatic Hypotension Symptom Assessment (OHSA) Question #1 Score at Week 4
Description	OHSA is an assessment of the severity of symptoms from low blood press...
Description	OHSA is an assessment of the severity of symptoms from low blood pressure. OHSA is a 6 question symptom assessment scale where each question uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. Question #1 assesses dizziness, lightheadedness, feeling faint, or feeling like you might blackout. A mean negative change from baseline indicates a better outcome.
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description

Participants included in the Full Analysis Set, defined as all randomized participants who received at least one dose of study medication and had at least 1 post-baseline measurement of Orthostatic Hypotension Symptom Assessment (OHSA) question 1, were included in this analysis.


Arm/Group Title	Ampreloxetine	Placebo
Arm/Group Description:	Participants received ampreloxetine...	Participants received placebo once ...
Arm/Group Description:	Participants received ampreloxetine at a dose of 10 mg once daily (QD) for 4 weeks. Ampreloxetine: Oral tablet, QD	Participants received placebo once daily (QD) for 4 weeks. Placebo: Oral tablet, QD
Overall Number of Participants Analyzed	94	90
Least Squares Mean (Standard Error) Unit of Measure: score on a scale
	-1.69 (0.290)	-1.45 (0.293)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ampreloxetine, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.574
	Comments	[Not Specified]
	Method	Mixed Model Repeated Measures
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.23
	Confidence Interval	(2-Sided) 95% -1.05 to 0.58
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.413
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Change From Baseline in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score at Week 4
Description	OHSA is an assessment of the severity of symptoms from low blood press...
Description	OHSA is an assessment of the severity of symptoms from low blood pressure. OHSA is a 6 question symptom assessment scale in which the composite score uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. A mean negative change from baseline indicates a better outcome.
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Ampreloxetine	Placebo
Arm/Group Description:	Participants received ampreloxetine...	Participants received placebo once ...
Arm/Group Description:	Participants received ampreloxetine at a dose of 10 mg once daily (QD) for 4 weeks. Ampreloxetine: Oral tablet, QD	Participants received placebo once daily (QD) for 4 weeks. Placebo: Oral tablet, QD
Overall Number of Participants Analyzed	90	87
Least Squares Mean (Standard Error) Unit of Measure: score on a scale
	-1.32 (0.200)	-1.05 (0.202)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ampreloxetine, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.331
	Comments	[Not Specified]
	Method	Mixed Model Repeated Measures
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.28
	Confidence Interval	(2-Sided) 95% -0.84 to 0.28
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.284
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Change From Baseline in Orthostatic Hypotension Daily Activities Scale (OHDAS) Composite Score at Week 4
Description	OHDAS is an assessment of how low blood pressure symptoms affect daily...
Description	OHDAS is an assessment of how low blood pressure symptoms affect daily life. OHDAS is a 4 item assessment in which the composite score uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. A mean negative change from baseline indicates a better outcome.
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Ampreloxetine	Placebo
Arm/Group Description:	Participants received ampreloxetine...	Participants received placebo once ...
Arm/Group Description:	Participants received ampreloxetine at a dose of 10 mg once daily (QD) for 4 weeks. Ampreloxetine: Oral tablet, QD	Participants received placebo once daily (QD) for 4 weeks. Placebo: Oral tablet, QD
Overall Number of Participants Analyzed	87	85
Least Squares Mean (Standard Error) Unit of Measure: score on a scale
	-1.22 (0.265)	-0.95 (0.267)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ampreloxetine, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.481
	Comments	[Not Specified]
	Method	Mixed Model Repeated Measures
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.27
	Confidence Interval	(2-Sided) 95% -1.01 to 0.48
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.376
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Number of Participants Who Experienced an Improvement From Baseline in Patient Global Impression of Change (PGI-C) Score at Week 4
Description	PGI-C was assessed using a 5-point scale where participants were asked...
Description	PGI-C was assessed using a 5-point scale where participants were asked to compare their current condition to their condition at baseline from 1 to 5, with 1 indicating the condition is very much improved and 5 indicating the condition is very much worse. These scores were analyzed in 2 categories: better and no change/worse.
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Ampreloxetine	Placebo
Arm/Group Description:	Participants received ampreloxetine...	Participants receives placebo once ...
Arm/Group Description:	Participants received ampreloxetine at a dose of 10 mg once daily (QD) for 4 weeks. Ampreloxetine: Oral tablet, QD	Participants receives placebo once daily (QD) for 4 weeks. Placebo: Oral tablet, QD
Overall Number of Participants Analyzed	91	87
Measure Type: Count of Participants Unit of Measure: Participants
	49 53.8%	45 51.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ampreloxetine, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.740
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by disease type

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95% -0.12 to 0.17
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.073
	Estimation Comments	The assumed common risk difference estimate and standard error are calculated using Mantel-Haenszel stratum weights and the Sato variance estimator. Mantel-Haenszel confidence limits are shown.

5.Secondary Outcome


Title	Number of Participants Who Experienced at Least One Fall
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Up to Week 4

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Ampreloxetine	Placebo
Arm/Group Description:	Participants received ampreloxetine...	Participants received placebo once ...
Arm/Group Description:	Participants received ampreloxetine at a dose of 10 mg once daily (QD) for 4 weeks. Ampreloxetine: Oral tablet, QD	Participants received placebo once daily (QD) for 4 weeks. Placebo: Oral tablet, QD
Overall Number of Participants Analyzed	93	90
Measure Type: Count of Participants Unit of Measure: Participants
	33 35.5%	22 24.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ampreloxetine, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0903
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by disease type

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 95% -0.02 to 0.24
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.064
	Estimation Comments	The assumed common risk difference estimate and standard error are calculated using Mantel-Haenszel stratum weights and the Sato variance estimator. Mantel-Haenszel confidence limits are shown.

Adverse Events

Time Frame	Up to Day 43
Adverse Event Reporting Description	Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.

Arm/Group Title	Ampreloxetine	Placebo
Arm/Group Description	Participants received ampreloxetine...	Participants received placebo once ...
Arm/Group Description	Participants received ampreloxetine at a dose of 10 mg once daily (QD) for 4 weeks. Ampreloxetine: Oral tablet, QD	Participants received placebo once daily (QD) for 4 weeks. Placebo: Oral tablet, QD
All-Cause Mortality
	Ampreloxetine	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/96 (0.00%)	0/90 (0.00%)
Serious Adverse Events Serious Adverse Events
	Ampreloxetine	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	4/96 (4.17%)	2/90 (2.22%)
General disorders
Asthenia ^† 1	1/96 (1.04%)	0/90 (0.00%)
Infections and infestations
Pneumonia ^† 1	1/96 (1.04%)	0/90 (0.00%)
Respiratory tract infection ^† 1	0/96 (0.00%)	1/90 (1.11%)
Urinary tract infection ^† 1	1/96 (1.04%)	0/90 (0.00%)
Renal and urinary disorders
Haematuria ^† 1	1/96 (1.04%)	0/90 (0.00%)
Vascular disorders
Orthostatic hypotension ^† 1	0/96 (0.00%)	1/90 (1.11%)
1 Term from vocabulary, MedDRA (24.0) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Ampreloxetine	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	42/96 (43.75%)	38/90 (42.22%)
Blood and lymphatic system disorders
Lymphadenopathy ^† 1	0/96 (0.00%)	1/90 (1.11%)
Gastrointestinal disorders
Nausea ^† 1	2/96 (2.08%)	2/90 (2.22%)
Constipation ^† 1	1/96 (1.04%)	1/90 (1.11%)
Dry mouth ^† 1	2/96 (2.08%)	0/90 (0.00%)
Vomiting ^† 1	1/96 (1.04%)	1/90 (1.11%)
Abdominal discomfort ^† 1	0/96 (0.00%)	1/90 (1.11%)
Duodenitis ^† 1	0/96 (0.00%)	1/90 (1.11%)
Gastric ulcer haemorrhage ^† 1	0/96 (0.00%)	1/90 (1.11%)
Gingival bleeding ^† 1	1/96 (1.04%)	0/90 (0.00%)
Large intestine polyp ^† 1	0/96 (0.00%)	1/90 (1.11%)
Salivary hypersecretion ^† 1	1/96 (1.04%)	0/90 (0.00%)
General disorders
Fatigue ^† 1	3/96 (3.13%)	1/90 (1.11%)
Asthenia ^† 1	1/96 (1.04%)	1/90 (1.11%)
Catheter site pain ^† 1	0/96 (0.00%)	1/90 (1.11%)
Chest discomfort ^† 1	1/96 (1.04%)	0/90 (0.00%)
Chest pain ^† 1	1/96 (1.04%)	0/90 (0.00%)
Gait disturbance ^† 1	1/96 (1.04%)	0/90 (0.00%)
Illness ^† 1	0/96 (0.00%)	1/90 (1.11%)
Influenza like illness ^† 1	1/96 (1.04%)	0/90 (0.00%)
Injection site pain ^† 1	0/96 (0.00%)	1/90 (1.11%)
Malaise ^† 1	0/96 (0.00%)	1/90 (1.11%)
Non-cardiac chest pain ^† 1	0/96 (0.00%)	1/90 (1.11%)
Oedema peripheral ^† 1	0/96 (0.00%)	1/90 (1.11%)
Pyrexia ^† 1	0/96 (0.00%)	1/90 (1.11%)
Temperature regulation disorder ^† 1	0/96 (0.00%)	1/90 (1.11%)
Hepatobiliary disorders
Hepatomegaly ^† 1	0/96 (0.00%)	1/90 (1.11%)
Infections and infestations
Urinary tract infection ^† 1	3/96 (3.13%)	4/90 (4.44%)
Upper respiratory tract infection ^† 1	0/96 (0.00%)	2/90 (2.22%)
Bacterial disease carrier ^† 1	1/96 (1.04%)	0/90 (0.00%)
Cystitis ^† 1	1/96 (1.04%)	0/90 (0.00%)
Oral candidiasis ^† 1	0/96 (0.00%)	1/90 (1.11%)
Injury, poisoning and procedural complications
Contusion ^† 1	0/96 (0.00%)	1/90 (1.11%)
Eye contusion ^† 1	0/96 (0.00%)	1/90 (1.11%)
Joint injury ^† 1	1/96 (1.04%)	0/90 (0.00%)
Skin abrasion ^† 1	1/96 (1.04%)	0/90 (0.00%)
Skin laceration ^† 1	1/96 (1.04%)	0/90 (0.00%)
Thermal burn ^† 1	0/96 (0.00%)	1/90 (1.11%)
Investigations
Blood creatinine phosphokinase increased ^† 1	1/96 (1.04%)	1/90 (1.11%)
Blood creatinine increased ^† 1	0/96 (0.00%)	1/90 (1.11%)
Blood urea increased ^† 1	0/96 (0.00%)	1/90 (1.11%)
Blood urea nitrogen/creatine ratio increased ^† 1	1/96 (1.04%)	0/90 (0.00%)
Crystal urine present ^† 1	1/96 (1.04%)	0/90 (0.00%)
Eosinophil count increased ^† 1	0/96 (0.00%)	1/90 (1.11%)
Gastric pH decreased ^† 1	1/96 (1.04%)	0/90 (0.00%)
Glomerular filtration rate decreased ^† 1	0/96 (0.00%)	1/90 (1.11%)
Lymphocyte count decreased ^† 1	0/96 (0.00%)	1/90 (1.11%)
Mean cell haemoglobin increased ^† 1	0/96 (0.00%)	1/90 (1.11%)
Mean cell volume increased ^† 1	0/96 (0.00%)	1/90 (1.11%)
Protein urine ^† 1	1/96 (1.04%)	0/90 (0.00%)
Weight increased ^† 1	0/96 (0.00%)	1/90 (1.11%)
White blood cell count increased ^† 1	0/96 (0.00%)	1/90 (1.11%)
Neutrophil count increased ^† 1	0/96 (0.00%)	1/90 (1.11%)
Metabolism and nutrition disorders
Hypokalaemia ^† 1	0/96 (0.00%)	1/90 (1.11%)
Musculoskeletal and connective tissue disorders
Muscle spasms ^† 1	2/96 (2.08%)	1/90 (1.11%)
Arthralgia ^† 1	1/96 (1.04%)	1/90 (1.11%)
Back pain ^† 1	0/96 (0.00%)	2/90 (2.22%)
Joint swelling ^† 1	1/96 (1.04%)	1/90 (1.11%)
Muscular weakness ^† 1	0/96 (0.00%)	1/90 (1.11%)
Myalgia ^† 1	0/96 (0.00%)	1/90 (1.11%)
Pain in extremity ^† 1	1/96 (1.04%)	0/90 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer ^† 1	0/96 (0.00%)	1/90 (1.11%)
Nervous system disorders
Headache ^† 1	5/96 (5.21%)	3/90 (3.33%)
Dizziness ^† 1	3/96 (3.13%)	0/90 (0.00%)
Somnolence ^† 1	2/96 (2.08%)	0/90 (0.00%)
Amnesia ^† 1	1/96 (1.04%)	0/90 (0.00%)
Balance disorder ^† 1	0/96 (0.00%)	1/90 (1.11%)
Bulbar palsy ^† 1	1/96 (1.04%)	0/90 (0.00%)
Depressed level of consciousness ^† 1	1/96 (1.04%)	0/90 (0.00%)
Dizziness postural ^† 1	1/96 (1.04%)	0/90 (0.00%)
Dysgeusia ^† 1	1/96 (1.04%)	0/90 (0.00%)
Hypoaesthesia ^† 1	1/96 (1.04%)	0/90 (0.00%)
Lethargy ^† 1	1/96 (1.04%)	0/90 (0.00%)
Loss of consciousness ^† 1	1/96 (1.04%)	0/90 (0.00%)
Paraesthesia ^† 1	1/96 (1.04%)	0/90 (0.00%)
Psychiatric disorders
Insomnia ^† 1	3/96 (3.13%)	1/90 (1.11%)
Anxiety ^† 1	2/96 (2.08%)	1/90 (1.11%)
Abnormal dreams ^† 1	1/96 (1.04%)	0/90 (0.00%)
Disorientation ^† 1	0/96 (0.00%)	1/90 (1.11%)
Renal and urinary disorders
Haematuria ^† 1	0/96 (0.00%)	1/90 (1.11%)
Bladder pain ^† 1	1/96 (1.04%)	0/90 (0.00%)
Nephrolithiasis ^† 1	0/96 (0.00%)	1/90 (1.11%)
Pollakiuria ^† 1	1/96 (1.04%)	0/90 (0.00%)
Urinary retention ^† 1	1/96 (1.04%)	0/90 (0.00%)
Urinary tract inflammation ^† 1	0/96 (0.00%)	1/90 (1.11%)
Urine flow decreased ^† 1	1/96 (1.04%)	0/90 (0.00%)
Renal cyst ^† 1	0/96 (0.00%)	1/90 (1.11%)
Reproductive system and breast disorders
Prostatitis ^† 1	0/96 (0.00%)	1/90 (1.11%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	0/96 (0.00%)	1/90 (1.11%)
Epistaxis ^† 1	1/96 (1.04%)	0/90 (0.00%)
Oropharyngeal pain ^† 1	1/96 (1.04%)	0/90 (0.00%)
Rhinorrhoea ^† 1	1/96 (1.04%)	0/90 (0.00%)
Skin and subcutaneous tissue disorders
Erythema ^† 1	1/96 (1.04%)	1/90 (1.11%)
Rash ^† 1	1/96 (1.04%)	1/90 (1.11%)
Pruritus ^† 1	1/96 (1.04%)	0/90 (0.00%)
Skin lesion ^† 1	0/96 (0.00%)	1/90 (1.11%)
Vascular disorders
Supine hypertension ^† 1	1/96 (1.04%)	3/90 (3.33%)
Hypertension ^† 1	3/96 (3.13%)	0/90 (0.00%)
Orthostatic hypotension ^† 1	0/96 (0.00%)	1/90 (1.11%)
Flushing ^† 1	1/96 (1.04%)	0/90 (0.00%)
Hot flush ^† 1	0/96 (0.00%)	1/90 (1.11%)
1 Term from vocabulary, MedDRA (24.0) † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Medical Monitor
Organization:	Theravance Biopharma Inc
Phone:	1-855-633-8479
EMail:	medinfo@theravance.com

Layout table for additonal information

Responsible Party:	Theravance Biopharma
ClinicalTrials.gov Identifier:	NCT03750552
Other Study ID Numbers:	0169 2018-003289-15 ( EudraCT Number )
First Submitted:	November 20, 2018
First Posted:	November 23, 2018
Results First Submitted:	July 20, 2022
Results First Posted:	September 14, 2022
Last Update Posted:	September 14, 2022

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