- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05918458
Discovering Clinical Study Experiences of Patients With Pulmonary Hypertension
Pulmonary Hypertension Clinical Trials: What Are Prevailing Patient Experiences in Pulmonary Hypertension Studies
Taking part in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.
This study will admit a wide range of data on the clinical trial experience of pulmonary hypertension patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.
It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future pulmonary hypertension patients.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Michael B Gill
- Phone Number: 415-900-4227
- Email: bask@withpower.com
Study Locations
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California
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San Francisco, California, United States, 94107
- Power Life Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged ≥ 18 years old
- Able to comprehend the investigational nature of the protocol and provide informed consent
- Diagnosis of pulmonary hypertension
Exclusion Criteria:
- No diagnosis of pulmonary hypertension confirmed
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients who decide to enroll in a pulmonary hypertension clinical research
Time Frame: 3 months
|
3 months
|
Rate of patients who remain in pulmonary hypertension clinical research to trial completion
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Michael B Gill, Power Life Sciences Inc.
Publications and helpful links
General Publications
- Jais X, Brenot P, Bouvaist H, Jevnikar M, Canuet M, Chabanne C, Chaouat A, Cottin V, De Groote P, Favrolt N, Horeau-Langlard D, Magro P, Savale L, Prevot G, Renard S, Sitbon O, Parent F, Tresorier R, Tromeur C, Piedvache C, Grimaldi L, Fadel E, Montani D, Humbert M, Simonneau G. Balloon pulmonary angioplasty versus riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (RACE): a multicentre, phase 3, open-label, randomised controlled trial and ancillary follow-up study. Lancet Respir Med. 2022 Oct;10(10):961-971. doi: 10.1016/S2213-2600(22)00214-4. Epub 2022 Aug 1.
- Divers C, Platt D, Wang E, Lin J, Lingohr-Smith M, Mathai SC. A Review of Clinical Trial Endpoints of Patients with Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension and How They Relate to Patient Outcomes in the United States. J Manag Care Spec Pharm. 2017 Jan;23(1):92-104. doi: 10.18553/jmcp.2017.23.1.92.
- Harder EM, Waxman AB. Clinical trials in group 3 pulmonary hypertension. Curr Opin Pulm Med. 2020 Sep;26(5):391-396. doi: 10.1097/MCP.0000000000000694.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 82814554
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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