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NCT04193046 · ClinicalTrials.gov registry record · Early Phase 1
A Study for the Identification of Biomarker Signatures for Early Detection of Pulmonary Hypertension (PH)
A Early Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 907
- Enrollment target
NCT04193046 is a Early Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 907 participants.
The verdict
NCT04193046, a Early Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 907 participants
- Enrollment target
Study Summary
The primary purpose of this study is to identify and develop biomarker signatures based on circulating micro ribonucleic acid (RNA) in the blood samples associated with high risk of pulmonary hypertension (PH) to assist in the diagnosis of PH; to estimate the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures in identifying participants with PH by comparing the biomarker signatures to right heart catheterization (RHC) and to compare the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures with the sensitivity, specificity, positive predictive value, and negative predictive value of transthoracic echocardiogram (TTE) in identifying participants with PH documented by RHC.
Interventions
- OTHER Blood Sample
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 907 participants |
| Start Date | 2019-12-16 |
| Est. Completion | 2022-02-18 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04193046
The ClinicalTrials.gov registry entry for NCT04193046 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 907 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Blood Sample is the first listed.
NCT04193046 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04193046 about?
NCT04193046 is a clinical study titled "A Study for the Identification of Biomarker Signatures for Early Detection of Pulmonary Hypertension (PH)". The primary purpose of this study is to identify and develop biomarker signatures based on circulating micro ribonucleic acid (RNA) in the blood samples associated with high risk of pulmonary hypertension (PH) to assist in the diagnosis of PH; to estimate the sensitivity, specificity, positive predi...
What is the current status of trial NCT04193046?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 907 participants. The study started on 2019-12-16. Estimated completion is 2022-02-18.
What interventions are being tested in trial NCT04193046?
The interventions under investigation include: Blood Sample (OTHER).
Who is sponsoring clinical trial NCT04193046?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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