Last updated: 03/30/2019 07:40:28
Qualitative research to explore treatment preference in pulmonary arterial hypertension (PAH) subjects
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Qualitative research to explore patient preference for modes of administration in pulmonary arterial hypertension treatments
Trial description: GlaxoSmithKline (GSK) is embarking on a clinical program to assess the treatment of PAH with an Angiotensin converting enzyme 2 (ACE2). This new treatment may require subcutaneous administration, in comparison to current treatments which are taken orally. Hence, GSK would like to conduct this qualitative interview study with PAH subjects to explore subject’s perspective and preferences for various modes of treatment administration (daily or weekly subcutaneous injection versus current treatment options). This will be a qualitative study comprising the conduct of semi-structured telephone concept elicitation interviews with 8 to 10 PAH subjects (each approximately 30 minutes in duration) in the United States (US).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects who preferred subcutaneous injection versus current treatment options
Timeframe: Up to 30 minutes
Secondary outcomes:
Not applicable
Interventions:
Other: Telephone concept elicitation interview
Enrollment:
10
Observational study model:
Cohort
Primary completion date:
2018-10-04
Time perspective:
Cross-Sectional
Clinical publications:
Not applicable
Medical condition
Hypertension, Pulmonary
Product
GSK2586881
Collaborators
Adelphi Values
Study date(s)
November 2017 to April 2018
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Male or female, at least 18 years of age.
- Subject is willing and able to provide written informed consent.
- Subject has a diagnosis of other cardiac or pulmonary disease.
- Subject has a Type II-V diagnosis of PAH, as per the WHO clinical classification system.
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female, at least 18 years of age.
- Subject is willing and able to provide written informed consent.
- Subject must have a diagnosis of symptomatic Pulmonary Arterial Hypertension Type I as per the World Health Organization (WHO) clinical classification system.
- Subject must have the cognitive and linguistic capabilities sufficient to allow them to actively participate in an interview lasting 30 minutes.
Exclusion criteria:
- Subject has a diagnosis of other cardiac or pulmonary disease.
- Subject has a Type II-V diagnosis of PAH, as per the WHO clinical classification system.
- Subject is currently receiving treatment for PAH via modes of administration other than intravenously or orally.
Trial location(s)
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02210
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2018-10-04
Actual study completion date
2018-10-04
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Participate in clinical trial
Additional information
Results for study 207754 can be found on the GSK Clinical Study Register.
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