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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: Completed Early Phase 1 study, sponsored by Janssen Research & Development.
NCT04193046 is a Early Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 907 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (1611% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood samples will be collected for micro Ribonucleic acid (miRNA) assay by qPCR to identify a biomarker signature for the early detection of pulmonary hypertension (PH).
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 |
What the finished NCT04193046 record still lists
NCT04193046 is an interventional study that assigns participants to a tested intervention. The registered 907 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (1611% higher).
The record links to 0 conditions, and to 1 intervention - of which Blood Sample is the first listed.
NCT04193046 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04193046's enrollment target sits among peer trials
907 12th of 2000 higher than 1,989 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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